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epidural man

epidural man

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So is anyone concerned that NEVRO is in trouble with the FDA from not reporting the ridiculous amounts of infections they have had? Does it concern any of you that have gone completely over to Nevro?

Another question...did my first trial with the Boston's new battery. I liked it very much. Is this a game changer for anyone?

Finally a request - when naming the new battery...it was originally going to be called Ninja - but some fancy suit type at Boston Scientific didn't like that so they call it Wave Writer (so dumb....). So can we all just commit to call the new battery "Ninja"? I am going to do that.
 
epidural man said:
So is anyone concerned that NEVRO is in trouble with the FDA from not reporting the ridiculous amounts of infections they have had? Does it concern any of you that have gone completely over to Nevro?

Another question...did my first trial with the Boston's new battery. I liked it very much. Is this a game changer for anyone?

Finally a request - when naming the new battery...it was originally going to be called Ninja - but some fancy suit type at Boston Scientific didn't like that so they call it Wave Writer (so dumb....). So can we all just commit to call the new battery "Ninja"? I am going to do that.
Click to expand...

I've done a lot of Nevro implants, haven't noted an infection trend yet. Or with any device for that matter.

Was the issue an increased # of infections relative to other companies or simply that they withheld reporting it?
 
I think that since they have had the reps wait two weeks before starting the stim the infection rates have gone to normal.
Dirty fingers futzing with a fresh incision daily will lead to infection. Not rocket surgery.


I have had infections with every system and with 5 different docs implanting, including myself. I have done better since I started prescribing post op clinda or Bactrim.

@gdub25
 
epidural man said:
... NEVRO is in trouble with the FDA from not reporting the ridiculous amounts of infections they have had...
Click to expand...
Didn't know but I'm not surprised. I've never had a trial (done by me) or implant (referred out), get infected, until recently. Recently, I temporarily opened up to all the companies and did two Nevro trials. The trials went okay but, guess what? 1 of two got infected at implantation, and had to be explanted. 50% personal infection rate with Nevro!
 
Last edited:
BobBarker said:
I think that since they have had the reps wait two weeks before starting the stim the infection rates have gone to normal.
Dirty fingers futzing with a fresh incision daily will lead to infection. Not rocket surgery.


I have had infections with every system and with 5 different docs implanting, including myself. I have done better since I started prescribing post op clinda or Bactrim.

@gdub25
Click to expand...

? Are you referring to the patients charging daily over the fresh incision

My peeps wear abdominal binders 24/7 until I see them 8-10 days postop. I think they charge over the binder.

I do postop abx x 14 days for everyone
 
emd123 said:
OMG, Seriously!!!!?????

I've never had a trial (done by me) or implant (referred out), get infected, until recently.
I temporarily opened up to all the companies and did two Nevro trials. The trials went okay but, guess what? 1 of two got infected at implantation, had to be explanted. 50% personal infection rate with Nevro!
Click to expand...

It's a bigger bulkier battery. Definitely have to make a bigger pocket. I wonder if some of these "infections" are actually wound dehiscence secondary to poor closure techniques with people rushing to finish, running the fascial layer and then stapling..

- ex 61N
 
Yes. My patients were charging daily over the fresh incision. I wasn’t doing the implants st the time.
 
61November said:
It's a bigger bulkier battery. Definitely have to make a bigger pocket. I wonder if some of these "infections" are actually wound dehiscence secondary to poor closure techniques with people rushing to finish, running the fascial layer and then stapling..

- ex 61N
Click to expand...
I don't know about the others, but this one was red, hot, obviously infected and didn't dehisce. Pussed out.
 
I thought post-operative abx were shown to be detrimental and recommended against?

Our guys are just using that Medtronic Tyrx envelope in all implants to reduce risk. The literature from the cardiac pacemaker side makes it a no brainer.
A meta-analysis of antibacterial envelope use in prevention of cardiovascular implantable electronic device infection. - PubMed - NCBI

The charge burden and aggressive interacting early on with Nevro makes it higher risk for issues, as does the battery size, but if it really does work as well as they state, it might be worth the issues. I haven't had luck with it though.
 
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ANALYSIS OF MAUDE FDA REPORTS FOR NEVRO RECEIVED 1/12/18-2/28/18 (Dates are date of event, not reported date)- ANALYSIS OF The LAST 100 REPORTS RECEIVED (out of the 486 received)

46% of reports were due to infection
Many others were due to unrelated deaths
Other causes for reports are listed below:


TUOHY Detached from hub 1/31/18


CSF Leak during implantation 1/30/18, 11/2/17, 8/4/17


SUBCUTANEOUS HEMATOMA/PAIN- device explanted 1/26/18


EPIDURAL HEMATOMA- Device Explanted 1/26/18


PARALYSIS ONE LEG AFTER IMPLANTATION- Device explanted 2/01/18


WOUND HEALING ISSUES AT POCKET- Device explanted 1/30/18, 1/2/18


WOUND HEALING ISSUE AT POCKET- antibiotics given, wound debrided 1/24/18, 1/4/18, 1/5/18


WOUND HEALING ISSUE AT POCKET- pocket revision- no explant 1/17/18


WOUND HEALING ISSUE AT LEAD INCISION- 1/3/18


INFECTION AT LEAD INCISION SITE- device explanted 1/22/18, 1/5/18, 2/1/17, 11/18/16, 4/12/16, 9/13/16


INFECTION AT LEAD INCISION SITE- no explant 12/23/16


INFECTION AFTER IMPLANTATION- device explanted 1/26/18


HOSPITALIZED DUE TO CSF LEAK- blood patch 1/2/18


EROSION OF DEVICE THROUGH SKIN- IPG repositioned 1/25/18


EROSION OF ANCHORS/LEAD INCISION SITE- explanted due to patient being thin 1/9/18


INFECTION OF STIM SYSTEM FROM CELLULITIS OF LEGS- explanted 1/11/18


PATIENT FELL- INCISION OPENED, BECAME INFECTED- explanted 12/18/17


BLOOD CLOT FORMED AROUND DEVICE AFTER IMPLANT, PLACING PRESSURE ON A NERVE RENDERING ONE LEG IMMOBILE- explanted 1/19/18


INFECTION IPG SITE- not explanted 1/17/18, 10/10/17, 3/20/17, 11/21/17


INFECTION IPG SITE- explanted 1/16/17, 10/3/17, 1/16/18, 7/14/17, 1/10/18, 1/5/18, 10/17/17, 1/26/16, 9/8/15, 9/1/17, 8/10/17, 6/5/17, 8/1/17, 8/15/17, 2/23/17, 10/5/16, 2/16/16, 10/14/16, 11/30/16, 5/12/17, 11/09/16, 2/24/17, 12/27/17, 12/26/17, 3/17/16, 1/29/16, 8/30/17, 12/20/17, 12/21/17, 9/17/16


ITCHING THROUGHOUT BODY- 2 Nevro devices explanted 11/30/17


INFECTION IPG DUE TO FISTULA FORMING BETWEEN POCKET AND PREVIOUS INFECTION SURROUNDING SPINAL HARDWARE- device explanted 1/16/18


SECONDARY INFECTION of POCKET FROM UTI- explanted 1/5/18


LOW IMPEDENCE- New pain bil LE- explanted 11/30/17


SEROMA AT IPG- drained - no explantation 12/28/17, 12/28/17, 12/8/17


HEMATOMA IPG SITE- no explantation 11/10/17
 
Technique related and daily charge related. I had one superficial infection treated with wound care and dressing changes and one short course (7d) oral Abx.
Been at this 14 years now. To eliminate risk of early infection from daily charging, one of two things should happen. 1. Do not turn on device until post-op OV at 7 days. 2. Educate patient on hand hygiene, risk of infection, and get them a box of tegaderm to place over the dressing prior to charging.

Not rocket science.
 
Orin said:
I thought post-operative abx were shown to be detrimental and recommended against?

Our guys are just using that Medtronic Tyrx envelope in all implants to reduce risk. The literature from the cardiac pacemaker side makes it a no brainer.
A meta-analysis of antibacterial envelope use in prevention of cardiovascular implantable electronic device infection. - PubMed - NCBI
Click to expand...

I agree - post op abx seems like a bad idea.

Is everyone irrigating the crap out of the pocket before battery placement and taking off their outer glove and putting on a new glove before handling the battery?

We asked for the plastic surgeons SOP for breast implants and try to follow that.

I know one physician will irrigate the breast pocket with dilute betasine solution. I’ve seen some data on that. I should probably start doing that.

I wonder if early charging makes a difference. I think with the wound closed with Dermabond, I just don’t see charging as an issue.
 
epidural man said:
I agree - post op abx seems like a bad idea.

Is everyone irrigating the crap out of the pocket before battery placement and taking off their outer glove and putting on a new glove before handling the battery?

We asked for the plastic surgeons SOP for breast implants and try to follow that.

I know one physician will irrigate the breast pocket with dilute betasine solution. I’ve seen some data on that. I should probably start doing that.

I wonder if early charging makes a difference. I think with the wound closed with Dermabond, I just don’t see charging as an issue.
Click to expand...

No glove change. GU solution for irrigation after pocket made, then packed with Raytek. Midline wound irrigated after leads sutured in. Pre-op ABX for SCHIP guidelines. 2-3G Ancef within 45 min of incision. Clinda 900 for PCN allergy. I do not lay battery on skin. I keep Rayteks between leads and skin when inserting leads through Tuohys and before putting through tunnel tool. I also use Integuseal for every case. It is from Kimberly Clark and is basically a liquid Ioban.
 
epidural man said:
I agree - post op abx seems like a bad idea.

Is everyone irrigating the crap out of the pocket before battery placement and taking off their outer glove and putting on a new glove before handling the battery?

We asked for the plastic surgeons SOP for breast implants and try to follow that.

I know one physician will irrigate the breast pocket with dilute betasine solution. I’ve seen some data on that. I should probably start doing that.

I wonder if early charging makes a difference. I think with the wound closed with Dermabond, I just don’t see charging as an issue.
Click to expand...

Irrigation is pulsed lavage with bacitracin solution. I also put vanc powder in the wounds.

3 layer closure with dermabond. Abdominal binder, nothing touches the site until 8-10 days postop, they charge over the binder. I don't change gloves

I don't make the battery pocket until my leads are sutured in and the midline incision is packed with abx soaked lap/raytek

how expensive is integuseal?
 
Aether2000 said:
ANALYSIS OF MAUDE FDA REPORTS FOR NEVRO RECEIVED 1/12/18-2/28/18 (Dates are date of event, not reported date)- ANALYSIS OF The LAST 100 REPORTS RECEIVED (out of the 486 received)

46% of reports were due to infection
Many others were due to unrelated deaths
Other causes for reports are listed below:


TUOHY Detached from hub 1/31/18


CSF Leak during implantation 1/30/18, 11/2/17, 8/4/17


SUBCUTANEOUS HEMATOMA/PAIN- device explanted 1/26/18


EPIDURAL HEMATOMA- Device Explanted 1/26/18


PARALYSIS ONE LEG AFTER IMPLANTATION- Device explanted 2/01/18


WOUND HEALING ISSUES AT POCKET- Device explanted 1/30/18, 1/2/18


WOUND HEALING ISSUE AT POCKET- antibiotics given, wound debrided 1/24/18, 1/4/18, 1/5/18


WOUND HEALING ISSUE AT POCKET- pocket revision- no explant 1/17/18


WOUND HEALING ISSUE AT LEAD INCISION- 1/3/18


INFECTION AT LEAD INCISION SITE- device explanted 1/22/18, 1/5/18, 2/1/17, 11/18/16, 4/12/16, 9/13/16


INFECTION AT LEAD INCISION SITE- no explant 12/23/16


INFECTION AFTER IMPLANTATION- device explanted 1/26/18


HOSPITALIZED DUE TO CSF LEAK- blood patch 1/2/18


EROSION OF DEVICE THROUGH SKIN- IPG repositioned 1/25/18


EROSION OF ANCHORS/LEAD INCISION SITE- explanted due to patient being thin 1/9/18


INFECTION OF STIM SYSTEM FROM CELLULITIS OF LEGS- explanted 1/11/18


PATIENT FELL- INCISION OPENED, BECAME INFECTED- explanted 12/18/17


BLOOD CLOT FORMED AROUND DEVICE AFTER IMPLANT, PLACING PRESSURE ON A NERVE RENDERING ONE LEG IMMOBILE- explanted 1/19/18


INFECTION IPG SITE- not explanted 1/17/18, 10/10/17, 3/20/17, 11/21/17


INFECTION IPG SITE- explanted 1/16/17, 10/3/17, 1/16/18, 7/14/17, 1/10/18, 1/5/18, 10/17/17, 1/26/16, 9/8/15, 9/1/17, 8/10/17, 6/5/17, 8/1/17, 8/15/17, 2/23/17, 10/5/16, 2/16/16, 10/14/16, 11/30/16, 5/12/17, 11/09/16, 2/24/17, 12/27/17, 12/26/17, 3/17/16, 1/29/16, 8/30/17, 12/20/17, 12/21/17, 9/17/16


ITCHING THROUGHOUT BODY- 2 Nevro devices explanted 11/30/17


INFECTION IPG DUE TO FISTULA FORMING BETWEEN POCKET AND PREVIOUS INFECTION SURROUNDING SPINAL HARDWARE- device explanted 1/16/18


SECONDARY INFECTION of POCKET FROM UTI- explanted 1/5/18


LOW IMPEDENCE- New pain bil LE- explanted 11/30/17


SEROMA AT IPG- drained - no explantation 12/28/17, 12/28/17, 12/8/17


HEMATOMA IPG SITE- no explantation 11/10/17
Click to expand...

What do you make of this Algos? Is this correlation or causation? Do you think Nevro is a/w higher infection risk even controlling for good surgical technique and postoperative care?
 
Can someone explain how touching the site would increase infection rates? A clean wound can be epithelialized in 12 hours.

If you aren't changing (or at least removing) the outer glove before handling the implant -consider doing so. It is SO simple and cheap, and not only makes sense, has data that supports the practice.

Pulsed lavage is controversial. So is bacitracin irrigation.
 
It would require a corresponding evaluation of another manufacturers data to be compared with the nevro data in order to be valid. I will try to do this in the next few days.
 
Aether2000 said:
It would require a corresponding evaluation of another manufacturers data to be compared with the nevro data in order to be valid. I will try to do this in the next few days.
Click to expand...

I wonder how many of these infections were simply due to increased utilization of Nevro in poor risk patients- smokers, very obese, diabetics, chronic steroids
 
epidural man said:
Can someone explain how touching the site would increase infection rates? A clean wound can be epithelialized in 12 hours.

If you aren't changing (or at least removing) the outer glove before handling the implant -consider doing so. It is SO simple and cheap, and not only makes sense, has data that supports the practice.

Pulsed lavage is controversial. So is bacitracin irrigation.
Click to expand...

Can you please elaborate on why pulsed lavage and bacitracin are controversial?
 
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epidural man said:
Can someone explain how touching the site would increase infection rates? A clean wound can be epithelialized in 12 hours.

If you aren't changing (or at least removing) the outer glove before handling the implant -consider doing so. It is SO simple and cheap, and not only makes sense, has data that supports the practice.

Pulsed lavage is controversial. So is bacitracin irrigation.
Click to expand...

The argument is one primarily of site contamination leading to a superficial site infection and then a deep infection. I'm of the mind set that you need an occlusive dressings in place for a 48 - 72h post-operatively, but the data are mixed.

CDC Guideline for the Prevention of Surgical Site Infection, 2017
The updated guidelines do push away from irrigation but are okay with it for deep incisions.
2A.1. Randomized controlled trial evidence suggested uncertain trade-offs between the benefits and harms regarding intraoperative antimicrobial irrigation (eg, intra-abdominal, deep, or subcutaneous tissues) for the prevention of SSI. Other organizations have made recommendations based on the existing evidence, and a summary of these recommendations can be found in the Other Guidelines section of the narrative summary for this question (eAppendix 1 of the Supplement). (No recommendation/unresolved issue.)

9A. Consider intraoperative irrigation of deep or subcutaneous tissues with aqueous iodophor solution for the prevention of SSI. Intraperitoneal lavage with aqueous iodophor solution in contaminated or dirty abdominal procedures is not necessary. (Category II–weak recommendation; moderate-quality evidence suggesting a trade-off between clinical benefits and harms.)

2B.1. Do not apply antimicrobial agents (ie, ointments, solutions, or powders) to the surgical incision for the prevention of SSI. (Category IB–strong recommendation; low-quality evidence.)

There are some good things in those guidelines for risk reduction.

In general though, I suspect this is a size dependent phenomena, more so than a charge burden issue.
 
No comments on the ninja battery?

I love that it does both tonic stim and "high frequency" at the same time. I love that it uses and cycles through 11 electrodes. You can also do "burst" and high frequency, or burst and tonic stim.
 
Anyone other than Nevro or Abbott-
Burst: is cluster tonic
High frequency: is up to 1khz

Only 2 approved frequencies Neuromodulation so far in the literature (level one studies)

HF10 Senza
Burst Sunburst


Only other is for the DRG Accurate
 
what antibiotics are you using intraop for trials and post op for trials?
what do u use for PCN allergy patients?
 
painfree23 said:
what antibiotics are you using intraop for trials and post op for trials?
what do u use for PCN allergy patients?
Click to expand...
IM Ancef 30 min prio + po doxycycline (because it kills not only staph and strep, but also mrsa) while trial lead(s) in.

IM Clinda + po clinda in PEN allergic
 
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epidural man said:
So is anyone concerned that NEVRO is in trouble with the FDA from not reporting the ridiculous amounts of infections they have had? Does it concern any of you that have gone completely over to Nevro?

Another question...did my first trial with the Boston's new battery. I liked it very much. Is this a game changer for anyone?

Finally a request - when naming the new battery...it was originally going to be called Ninja - but some fancy suit type at Boston Scientific didn't like that so they call it Wave Writer (so dumb....). So can we all just commit to call the new battery "Ninja"? I am going to do that.
Click to expand...
wave writer has been fantastic in my limited experience so far. Patients are loving it
 
We tout studies when it helps us but ignore studies or lack there of at other times.

Wavewriter may have some real world experience but does it have any evidence as well?

I would advocate to anyone to use the companies with level one data for wanting to expand our field of Neuromodulation.

If other companies see that this matters to us then they won’t throw out gimmicks to catch our attention.

Gimmicks are good sometimes but we should demand more right now.

We have new waveforms/pulse trains, targets.

Companies like Mainstay and Saluda doing are doing reasearch as well and may disrupt the space soon.
 
emd123 said:
IM Ancef 30 min prio + po doxycycline (because it kills not only staph and strep, but also mrsa) while trial lead(s) in.

IM Clinda + po clinda in PEN allergic
Click to expand...
Unless there has been done brand new study out there, doxycycline is bacterostatic, not bacterocidal.

Do u mean dicloxacillin?
 
For the Ninja...are the patients complaining of increased charging times running high and tonic programs together? I’ve heard up to 3 hours/2 times a day with these combo programs.
 
Boston Montage was supposed to be Montana, too.

They need to stick with the names the r&d guys come up with.
 
emd123 said:
Tissue damage
Click to expand...
Dont quote me on the specifics physiology (med school is too long ago) but bacitracin is largely bacteriostatic, not bactericidal, meaning it will slowly inhibit cell wall synthesis but not kill anything. In my previous discussions with plastic surgeons regarding this, it would take bacitracin a minimum of 3-5 minutes to have any bacteriostatic effects, and that is leaving it in the wound for that period of time and your still not killing anything. I can assume we are using pulsed lavage to spray into the wound, and none of us sit there the minimum 5 minutes needed hoping it is having some bacteriostatic effects
 
Painted said:
For the Ninja...are the patients complaining of increased charging times running high and tonic programs together? I’ve heard up to 3 hours/2 times a day with these combo programs.
Click to expand...

I haven't had good luck with Boston so far. I don't like their Entrada needles for use with the Infinion leads. I agree with the above- running a lot of pseudo burst and "HF" at 1000 Hz increases the charge burden significantly I believe with the current battery.
 
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epidural man said:
No comments on the ninja battery?

I love that it does both tonic stim and "high frequency" at the same time. I love that it uses and cycles through 11 electrodes. You can also do "burst" and high frequency, or burst and tonic stim.
Click to expand...
if I remember correctly, you aren't a paid shill for BS.

so, let me get this straight...

if one type of therapy (say, HF1) doesn't work, and another therapy (tonic) doesn't work, but the combination of the two is going to work, right?

how does that calculate? I mean, from an analogy standpoint, I hate mushrooms, and I hate projectile vomiting. projectile vomiting mushrooms wont make anything better... :barf:
 
Personally, I don't think pulse width, pulse rate, pulse whatever makes a difference. Maybe it does - maybe it doesn't. Someone needs to prove it.

What probably makes a difference is energy delivered.

So..

Show me that the same energy delivered, with different pulse widths make a difference.

Show me that the same electric field strength but varying pulse widths and amplitudes makes a difference.
 
how about the difference between AM and FM radio? different wavelengths clearly make a difference to my ears...

or the fact that different wavelengths of electromagnetic energy produces different colors of light? which is how your pulse ox machine works...
 
Ducttape said:
how about the difference between AM and FM radio? different wavelengths clearly make a difference to my ears...

or the fact that different wavelengths of electromagnetic energy produces different colors of light? which is how your pulse ox machine works...
Click to expand...
Yeah

It makes sense that different wavelengths will produce different effects.

But it’s possible it is just a field strength issue.
 
Painted said:
For the Ninja...are the patients complaining of increased charging times running high and tonic programs together? I’ve heard up to 3 hours/2 times a day with these combo programs.
Click to expand...
Yes ninja uses more juice. Qday to qod charging is what I’ve heard so far. Have not heard 2x/ day but I could see that as possible. With the old medtronic surescan ipg it would only last 18h. Intellis hasn’t been much better but charges faster. Understand the capacity is no better with the intellis. When I asked them at the AAPM&R how the capacity compared (before I knew) they punted so I figured something was afoot.
 
Ducttape said:
if I remember correctly, you aren't a paid shill for BS.

so, let me get this straight...

if one type of therapy (say, HF1) doesn't work, and another therapy (tonic) doesn't work, but the combination of the two is going to work, right?

how does that calculate? I mean, from an analogy standpoint, I hate mushrooms, and I hate projectile vomiting. projectile vomiting mushrooms wont make anything better... :barf:
Click to expand...
I figured additive or synergistic effects. They are different neural targets. I agree that the studies still need to show us the proof. Just anecdotal right now. Planning to try some non-BS and OMG to compare and further bolster my anecdotal experience. I could give 2 ****s which stim I use, I just want the best (or at least something working well past 12 months) for my patients.
 
Jigsaw said:
We tout studies when it helps us but ignore studies or lack there of at other times.

Wavewriter may have some real world experience but does it have any evidence as well?

I would advocate to anyone to use the companies with level one data for wanting to expand our field of Neuromodulation.

If other companies see that this matters to us then they won’t throw out gimmicks to catch our attention.

Gimmicks are good sometimes but we should demand more right now.

We have new waveforms/pulse trains, targets.

Companies like Mainstay and Saluda doing are doing reasearch as well and may disrupt the space soon.
Click to expand...

The studies will be forthcoming. I think we are the tip of the iceberg. The field is rapidly changing right now. When we can take something that is proven to work, eg traditional tonic SCS, have the option to use unproven or not fully studied therapies (non-HF10 “HF” SCS, non-SJM burst, multiple simulatanepus waveforms) while still having the option to go back to the other proven therapy, I don’t see why not. SCS is very complex and still not fully (and I think very poorly) understood. It makes studying it challenging, anatomy is not identical so we end up leaning on our real world experience more. The plural of anecdote is not evidence, but additionally, one study is not authoritative with an ever changing field.
 
Check out all the studies that are done on BurstDR and HF10 besides the Senza and Sunburst study.

If you have a thought of using two systems with an option of tonic then Abbott with BurstDR and tonic fits.

Supposedly Senza tonic is not great.

Burst other than BurstDR is cluster tonic and does not light up the medial pathway. This was studied

HF10 is only used with Nevro. This was Studied

1k,4K, 7k, 10k was studied in the Proco study.

Whisper study was very lacking.

Now when you talk about randomness and something not studied well at all then go ahead and try something like targeting multiple stimulation patterns at a time.



I don’t care about these companies but I do care about OUR field.

When we fall for gimmicks and not research at this point then we are taking steps backwards.
 
MAUDE Data for BS Precision is running around a 10% reported infection rate vs. 42% for Nevro. Of course reporting is voluntary, and is only as reliable as the reporting entity. BS had many more charging issues and malfunctions of the stimulator due to using electrocautery.
 
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