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dennis100
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« on: May 22, 2017, 08:49:35 AM »

Model Number 302-20
Event Date 10/15/2013
Event Type  Malfunction   
Event Description
It was reported that the patient would have vns replacement surgery on (b)(6) 2013; however, follow-up information was received which indicated that vns was not implanted on this date. At the time of surgery, it was believed that the electrodes were not on the vagus nerve. The nerve was "disintegrated" and the surgeon had no assessment of what caused the event. No interventions were taken or planned. The generator and lead were explanted and discarded. The patient was not implanted with another vns device. It was unknown if this event was related to vns. No other information was provided.
 
Event Description
On (b)(6) 2013 it was reported that the patient was found to have high lead impedance during an office visit on (b)(6) 2013. The physician requested x-rays and the device was not disabled. The physician sated that the only trauma was that the patient recently had a mammogram which was a little rough but he did not think it would have caused any issues with the device. Clinic notes were received from the (b)(6) 2013 visit which indicated that the diagnostics test showed high lead impedance with a dcdc of 7. The physician indicated that the high impedance may be related to some scar tissue. The patient reported no seizure since her previous appointment in (b)(6) 2013. The patient was referred for surgery. A copy of the patient¿s x-rays were received for review. Due to image angle and quality, complete lead pin insertion cannot be assessed. The lead portion behind the generator cannot be assessed. There are no sharp angles in the lead; however, there is a suspect area of continuity in the lead portion in the chest. The assessment of community in this area is limited by image quality. Based on the images available, the suspect area of continuity in the lead may be a cause for the high impedance. The presence of a microfracture or a discontinuity in the lead portion not visible cannot be ruled out. Although surgery is likely, it has not occurred to date. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3484513
« Last Edit: October 02, 2018, 11:02:26 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 22, 2017, 08:50:57 AM »

Event Date 05/01/2009
Event Type  Injury   
Event Description 
My daughter had her first vns implanted in 2004. She did not have success, had many traumas with her throat, and it ultimately caused paralysis to her vocal cord. We were advised by our doctors to get another - new and improved - vns since we are trying to avoid additional meds and surgery on this pt. When the surgeon opened the area to replace the old with the new, he discovered darkened tissue, corrosion, and a complete failure of the device. He said, he had never seen it in over 300 vns surgeries. Because of the extent of the problem, he had to replace more than the generator, and had to attempt removal of the wire that has long been encased in scar tissue. We were advised by cyberonics that they could fully investigate and contact the fda. After 7-months, cyberonics can only identify's dodge-ball hit 4 years ago as the cause of failure. The device has read "normal" during this entire time on every routine recheck. We would never have known of this failure if we didn't have a second surgery. Cyberonics' investigation states the cause is "blunt force trauma" 4 years ago. Indeed, being cautious parents, we did see her neurologist after that incident to ask if the ball could possibly have caused damage - the neurologist assured us, but performed the standard usual diagnostics and said the device was not damaged - again, 4 years ago. Cyberonics also advised today that her current neurologist - md - did not perform recommended "diagnostics" on her device while under his care - approx. 1 year, but only "interrogations" which would not reveal a "failure" status. Dr surely had no idea that was required or he would have done a diagnostic reading. We thought that he "interrogations" he was doing, were "diagnostic" evaluations. The question looms as to when the device failed, and how would we have known it was in this condition, buried under her skin, showing no signs of distress. Our earlier problem with her paralyzed vocal cord was also met with disinterest as we sought to discover that caused the permanent condition. We could only suspect the vns was ramped up too quickly to higher intensities. If that were true, they would simply have to re-examine their protocol, but they did no investigation into cause. We quietly went away without pressing for an answer. Now, another encounter with the cyberonics product is met with the same response. Why aren't they concerned that their device was indicating "normal" at every office visit? since it never controlled her seizures, there were zero signs it was in this state. Cyberonics advised that their last communication with fda was in august, and they reported "lead failure" as the cause. Now, we have a second vns in her chest - no seizure improvement; in fact, worsening, and we have no idea what went wrong or when. The surgery doctors also remain baffled. Is there any accountability in this investigation process? is it up to me to keep pressing for resolution, or does the fda hold them accountable for such serious incidents? vocal cord paralysis - and an electrical failure resulting in darkened tissue - three years later does not seem to warrant an unbiased investigation that goes beyond proving their own blamelessness. I asked them today for the fda report, hoping to glean something on why, when, or how the device failed. Cyberonics said, they would not provide that info. It feels we are left begging cyberonics for a responsible response to this incident. I have contacted them no less than 12 times in 7 months via phone calls and emails. Cyberonics "deal with us". It was never our intent to be their problem. Only to understand more fully the risks we are exposed to with their device, how we can protect our daughter from further harm, and assist them in identifying product concerns. Advised she would have to contact their legal dept. To provide fda info. Why is that? we are a modest family, and do not have access to a legal department. Do incidents such as this require a legal department to provide people who have trusted them with answers?.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564881
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dennis100
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« Reply #2 on: May 22, 2017, 08:51:58 AM »

Model Number 101
Event Date 05/01/2010
Event Type  Malfunction   
Event Description 
It was initially reported by the surgeon that the pt had his battery replacement surgery due to eos. During the explant, surgeon noticed some signs of corrosion inside the generator. Explanted generator was returned to manufacturer for analysis. Analysis is currently pending on the generator.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1731650
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dennis100
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« Reply #3 on: May 22, 2017, 08:53:41 AM »

Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Device Brand Name: Demipulse
Device Manufacturer's Name: Cyberonics, Inc.
Date of this Report:
(mm/dd/yyyy) 08/18/2015
 
Describe the Event
or Problem: The patient complained that the device was "shocking" her. Implantation date is unknown. Per surgeon's note, there was corrosion on the inside of the lead of the Vagus Nerve Stimulator.
 
the device(s) may have
caused or contributed to: Potential for patient harm
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?id=45917
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dennis100
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« Reply #4 on: May 22, 2017, 08:55:20 AM »

Model Number 302-20
Device Problems Corrosion; Fracture; Mechanical issue 
Event Date 12/22/2016
Event Type  Malfunction   
Event Description 
It was reported that the patient was referred for a lead and generator replacement due to high impedance being observed. During the replacement surgery it was noted that the patient's vagus nerve appeared to be damaged. The surgeon reported that the nerve appeared atrophic and discolored immediately around and under the positive and negative electrodes. The surgeon could not determine the cause of the nerve's appearance but noted that the electrodes seemed to be more degenerated than usual. The explanted lead and generator were discarded following the surgery. Therefore product analysis cannot be completed. No additional relevant information has been received to date.
 
Event Description 
Analysis of the generator and lead were completed. As a part of testing the generator's output signal was monitored for a 24 hour period while it was placed in a simulated body temperature environment. During this period there were no observed variations in the output current of the generator. Analysis confirmed that the generator performed to functional specifications. It was noted that the lead was received as one portion which did not contain the electrodes or tie downs. Setscrew marks were observed on the lead's connector pin which indicated that at one time there had been proper mechanical contact between the generator and lead. Abrasions were observed in the outer tubing and it appeared that the cause of these abrasions were related to wear. A continuity check was performed on the returned lead portion and no discontinuities were identified. The analysis was unable to confirm the presence of a fracture in the portion of the lead that had been received.
 
Manufacturer Narrative 

Manufacturer Narrative 
Corrected data: describe event or problem; "it was reported that during the replacement surgery the lead's electrode appeared to be corroded. After the lead and generator were replaced the new system was programmed on and the patient began coughing. The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator. " this information was inadvertently left off on mfg. Report #0. Corrected data: (b)(4). This information was inadvertently left off on mfg. Report #0.
 
Event Description 
It was reported that during the replacement surgery the lead's electrode appeared to be corroded. After the lead and generator were replaced the new system was programmed on and the patient began coughing. The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator. The explanted lead and generator were received and are currently pending analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300905
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dennis100
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« Reply #5 on: May 22, 2017, 08:58:36 AM »

Model Number 302-20
Device Problems Corrosion; High impedance 
Event Date 10/01/2015
Event Type  Malfunction   
Manufacturer Narrative 

Manufacturer Narrative 
Adverse event, corrected data, initial mdr omitted information that was known prior to submission of the initial mdr required intervention to prevent permanent impairment/damage, corrected data, initial mdr omitted information that was known prior to submission of the initial mdr describe event or problem, corrected data, initial mdr omitted information that was known prior to submission of the initial mdr.
 
Event Description 
Product analysis was completed and approved for the lead on 11/11/2016. Scanning electron microscopy images of the connector pin show that pitting or electro-etching conditions have occurred on the pin surface. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead coils have a spiral/wavy appearance in some locations. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis for the generator was completed and approved on 11/15/2016. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. From the data dump, the patient's pre change diagnostics from (b)(6) 2016 show high impedance of 5359 ohms with a post change of 2627 ohms. This is indicative of intermittent high lead impedance.
 
Event Description 
The patient experienced painful stimulation in the neck after the patient was choked in 2015. The patient's replacement surgery was scheduled for this painful stimulation for patient comfort only. Since the date that the high impedance first occurred is unknown, it is possible that the high impedance contributed to the patient's painful stimulation.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6149620
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dennis100
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« Reply #6 on: May 22, 2017, 08:59:57 AM »

Model Number 102
Event Date 03/17/2008
Event Type  Malfunction   
Event Description
Reporter indicated that communication could not be established with a vns pt's generator. Communication was attempted with multiple programming systems. A battery life estimation was performed, and it resulted in 4. 65 years remaining until eri=yes, although the values used may not be representative of the pt's exact programmed parameters. The pt underwent revision surgery. The surgeon noted that during the revision there was significant corrosion at the generator header/lead connector pin interface. This led the surgeon to replace the generator and lead. The explanted devices have been received and are awaiting analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030362
« Last Edit: October 02, 2018, 11:03:55 AM by dennis100 » Logged
dennis100
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« Reply #7 on: May 22, 2017, 09:02:07 AM »

Model Number 102
Event Date 08/25/2011
Event Type  Injury   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death.
 
Event Description 
On december 6, 2011 additional information was received from the surgeon. The surgeon has no evidence that there was any patient manipulation that could have caused the high impedance or infection. No x-rays were taken. The surgeon stated that cultures were taken during surgery and both aerobic and anaerobic cultures were negative. The surgeon believes that the patient's events are directly related to the vns. He stated that the patient developed an increased seizure frequency in 2009 and a decision was made to replace the vns generator. When the new generator was turned on, the patient experienced significant pain and has had vocal cord paralysis since that point in time, approximately (b)(6) 2009. The lead was then replaced. The patient's vocal cord paralysis had not recovered by (b)(6) 2010 and she underwent operative nerve transposition to help with the vocal weakness. The patient was seen in (b)(6) 2011 with pain at the generator site. The patient had stated that she had been experiencing pain for several months prior and the surgeon stated that there was necrotic-appearing tissue at the incision site itself. The surgeon said he was concerned that there was a possible infection, but there was not purulent material at the time of surgery. The surgeon instead said there was very unusual appearing changes to the tissue surrounding the device, and the device itself had a hard metallic build up around it. The surgeon stated that therefore, the device was removed to prevent further injury. The surgeon did not say whether he was aware that the patient had high impedance since (b)(6) 2010 and whether or not the patient's device had been disabled.
 
Event Description 
Additional information was received on (b)(6) 2011 when the explanted generator and lead were returned to the manufacturer for product analysis. Product analysis was completed on the generator on (b)(6) 2011. Bodily fluid remnants were observed in the negative connector block and header cavity. The anomalies in the header area may have been a contributing factor to the adverse events. Corrosion/dried fluids and pitting conditions in the negative connector block and setscrew were observed and are most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. The septum was not cored. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Although initial visual analysis of the lead showed fluid ingress, full product analysis on the lead is still pending.
 
Event Description 
On (b)(6) 2012, additional information was received when the surgeon requested a copy of the product analysis results for the generator as he said the generator looked like it "might have leaked".
 
Manufacturer Narrative 
There were observed corrosion/dried fluids and pitting conditions in the negative connector block and setscrew that were most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis on the lead has not yet been completed.
 
Event Description 
Additional information was received on (b)(6) 2011 when product analysis was completed on the explanted lead. A large portion of the lead assembly body, including the electrodes, was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The connector pin quadfilar coil appeared to be broken approximately 213mm from the end of the connector boot. The area was identified as being thin which prevented identification of the coil fracture type with evidence of electro-etching, pitting and residual material on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Discoloration was observed inside the majority of the outer silicone tubing. Discoloration was observed throughout the inside of the connector pin inner silicone tubing and on the quadfilar coil. What appeared to be pieces of inner silicone tubing were observed inside the outer silicone tubing. The tubing discoloration suggests that fluid was present in the tubing at some point in time. Based on the returned lead portion, the initial location of fluid ingress into the tubing cannot be determined. With the exception of the identified discontinuity, pitting, and the discoloration observed, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure; no other obvious issues were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Additional information has been requested from the surgeon but no further information has been received to date.
 
Event Description 
On (b)(6) 2011, a vns implanting neurosurgeon reported that the after the patient's generator was replaced in (b)(6) 2009, the patient was experiencing vocal cord paralysis where her left vocal cord did not move and had to have a re-innervation procedure. The patient was seen again as she developed what looked like a burn or fungating mass over the generator site. The surgeon removed the generator on (b)(6) 2011 and he reported that it had appeared to have leaked into the pocket; there was metal and scar tissue on histology and the device looked like a rusted battery. Clinic notes from the surgeon were also received. The notes dated (b)(6) 2011 revealed that the patient was experiencing worsening pain at the generator pocket site and had gone to the hospital and been evaluated for any cardiac disease. No cardiac disease was found. She started using a heating pad over the device and she reported that she developed significant blistering at the incision site of the generator and that this has been slowly improving. The device has become more prominent and more painful over the last few weeks however. The surgeon reported that the patient's skin is black and convoluted over the patient's generator incision scar. The device is easily palpable and somewhat mobile. He stated that the patient has likely a burn with some necrosis of the skin at the generator site. It also seems that she may be developing an infection at the generator site and that it should be removed. The surgeon said the patient's seizure control is now much worse without the vns functioning. The operative report from the date of explant, (b)(6) 2011, was also received by the surgeon. The report reveals that the patient had an existing 5cm linear skin incision from the implant of the generator and that a central area of this had turned black and widened to about 0. 5 cm in size. Therefore, an incision was performed to ellipse out the prior scar. The subcutaneous fat was found to be relatively normal in appearance; however, a capsule was encountered with significant fluid and samples were taken for cultures. The capsule was relatively black in color and there appeared to be a wall of possible hemosiderin-stained tissue, several millimeters thick, all within the generator pocket. The surgeon reported that the color of the titanium close to the header of the generator was altered and pictures were taken of it. The surgeon also stated that there was also a collection of very hard black porous material intimately attached to the device. The generator was explanted and the skin biopsy was sent for pathological evaluation. The generator pocket was then copiously irrigated and all of the black material within the scar capsule was removed mechanically. The wound was then closed. The patient's programming history was reviewed in the manufacturer's database which revealed that high impedance was detected on (b)(6) 2010 with a system diagnostics test and normal mode diagnostics test showing results of output=limit/lead impedance =high/dcdc=7/eri=no. The patient was disabled that day to output =0ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec. The manufacturer's consultant reported that she obtained the explanted generator from the surgeon on (b)(6) 2011 and will be sending it back to the manufacturer for product analysis. It has not yet been received by the manufacturer to date. When additional information is received, it will be reported.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2253422
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dennis100
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« Reply #8 on: May 22, 2017, 09:04:34 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description 
The patient reported that she was diagnosed with left vocal cord paralysis by an ent in 2012. It was reported that the patient's neurologist has not programmed the device off to assess whether or not the paralysis is related to vns therapy. The patient reported that her neurologist "performed something that shocked her" in 2011 and since then she has had voice changes. The neurologist's office indicated that the patient¿s vocal cord paralysis could be related to vns therapy, but that the device has been very effective in helping to control the patient¿s seizures so they are not changed any device settings at this time. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative 

Event Description 
Follow up with the physician's office confirmed that the patient's left vocal cord paralysis was diagnosed by an ent. The patient's last appointment was in (b)(6) 2012. The patient has a history of myasthenia gravis (neuromuscular disease leading to fluctuating muscle weakness) that is not related to vns. Per clinic notes, the nurse noted that it looks like the patient "is developing increasing hoarseness. She had an ent evaluation which did show left vocal cord paralysis. " she also has eye droop which is from myasthenia, not vns. The nurse noted that they cannot ruled out the myasthenia as the potential cause for the difficulty swallowing and left vocal cord paralysis. The physician notes that they could remove the vns, but he indicates that he has discussed this in length with the patient and he cannot state that the laryngeal nerve would return to function even after vns removal. Per notes, "although it is possible that the vns electrodes have caused corrosion on the left laryngeal nerve, i have never experienced this in my cases" and the physician does not suspect this is the case. The patient understands and does not want surgery. She would rather keep vns because it seems to be controlling her seizures. Between (b)(6) 2013, the patient did not have any seizures. The patient is reportedly at "appropriate" settings (not specifically provided) which are helping her with her seizures so they do not want to change the settings. The physician confirmed that since the patient's seizures are well controlled, they do not want to try and change the patient's settings to see if it affects the vocal cord paralysis. At this time, the patient's voice is not worse but still scratchy. They performed an x-ray which showed the vns system was not broken. Copy of x-rays will not be provided to the manufacturer for review. It was indicated that the patient's medications were adjusted to a dose that would help her with myasthenia, but the patient is kind of self-adjusting on her medications. Diagnostics are within normal limits, and the nurse again indicated that they interrogated the device and "settings are where they need to be. The nurse was unsure of what the patient was referring to when she said she was "shocked" at her last visit, but stated that the vns cannot be ruled out it was in relation to the nerve. No additional information was provided.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3272783
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dennis100
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« Reply #9 on: May 22, 2017, 09:06:19 AM »

Model Number 300-20
Device Problems Break; Material disintegration 
Event Date 05/18/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported to the manufacturer that the vns pt began to experience an increase in seizure activity at pre-vns baseline and that the pt's seizures can no longer be aborted with magnet stimulation in (b) (6) 2009. The pt's generator was believed to be at end of service by the caregiver. The pt reportedly was seizure free with vns therapy until then. The pt's generator was replaced due to believed end of service condition and the lead was reportedly replaced prophylactically due to the longevity of the device. The explanted products were returned to the manufacturer for product analysis. Product analysis has been completed on the generator. The generator was found to be operating within designed limits and there were no performance or any other type of adverse conditions found. No anomalies were identified that could have contributed to the reported event. The end of service allegation on the generator was not duplicated in the laboratory. Product analysis has been completed on the returned lead portions by the manufacturer and discontinuities in the body region of both the positive and negative quadfilar coil wires were confirmed. Mechanical damage and metal dissolution was observed in the area of the lead break in the positive quadfilar coil. Due to metal dissolution and mechanical distortion, the fracture mechanism cannot be ascertained for this break. Mechanical damage was observed in the area of the lead break in the negative quadfilar coil but no metal dissolution was present. The fracture was determined to be stress induced fracture from the fatigue appearance in the area of this break. Abraded openings in the outer and inner tubing/insulation were visualized during product analysis. The lead assembly was visualized to have remnants for dry body fluids inside the outer and inner silicone tubing. The marked and unmarked connector boots and connector silicone tubes and electrode array section were not returned for analysis, therefore, an evaluation and resulting commentary cannot be made on that portion of the lead. Resistance measurement verified electrical and mechanical contact between the generator and the connector pins at one time. The pt's increase in seizure activity is most likely due to loss of therapy from the fractures observed in the lead body.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1585548
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« Reply #10 on: May 22, 2017, 09:08:20 AM »

Model Number 302-20
Event Date 04/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for both the generator and the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(4) 2013, it was reported that the patient underwent generator revision for a malfunction, and the lead was left intact; however, both the lead and generator were returned on (b)(4) 2013. A return product form indicated that the devices were returned due to high lead impedance. An implant card confirmed this information. The lead and generator are pending analysis.
 
Event Description
The generator analysis was completed on 08/27/2013. The generator performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 09/03/2013. During the visual analysis the (-) green electrode quadfilar coil appeared to be broken approximately 20mm and 26mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the areas as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that diagnostic testing resulted in high impedance. It was reported that the patient could no longer feel device stimulation. The patient was referred for generator and lead replacement surgery. The physician indicated that no causal or contributory programming or medication changed preceded the onset of the patient no longer feeling device stimulation. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The physician did not program the device off after observing the high impedance reading. No x-rays were taken. Surgery is planned; however, has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119147
« Last Edit: May 03, 2018, 02:09:20 AM by dennis100 » Logged
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« Reply #11 on: May 22, 2017, 09:10:14 AM »

Model Number 102
Event Date 01/01/2009
Event Type  Injury   
Event Description 
On (b)(4) 2012, additional information was received. The physician stated that coma in 2009 did not involve vns; however, he was not willing to provide any additional information. The patient's programming history for the year 2009 was reviewed.
 
Manufacturer Narrative 

Manufacturer Narrative 
Analysis of programming history.
 
Event Description 
On (b)(6) 2012, it was reported that this vns patient had a cat scan in 2009 and began to have seizures after the event. The reporter stated that the patient had continuous seizures and had to be hospitalized, at which point the patient was put into a coma. The generator and lead were explanted on (b)(6) 2012 and returned for product analysis on (b)(6) 2012. Product analysis for the generator was approved on (b)(6) 2012. The results indicated that the generator performed according to functional specifications, and no anomalies were found with the pulse generator. Product analysis for the lead was approved on (b)(6) 2012. Lead fracture and corrosion were both identified in the results of product analysis; however, this did not cause or contribute to a death or serious injury (previously reported in mfr report # 1644487-2012-00679). Attempts for additional information are underway.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2604594
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« Reply #12 on: May 22, 2017, 09:12:05 AM »

Model Number 102
Device Problems High impedance; Migration of device or device component 
Event Date 01/01/2015
Event Type  Injury   
Event Description 
It was reported that the patient's generator had migrated from its original position to the patient's armpit whenever she moved in a certain way. The patient was seen by the physician and referred for surgery to correct the migration of the device. The physician noted that the generator does shift significantly under the skin in the left pectoral region. Manipulation of the pulse generator causes significant discomfort to patient in the chest and also some hoarseness of the voice. Additional information was received that no trauma or manipulation is suspected. Diagnostics were reported to be within normal limits with no high impedance. Patient underwent full revision surgery on (b)(6) 2015. Diagnostics were attempted but patient experienced left neck pain and coughing with stimulation. Upon opening generator pocket the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead as well (reported in manufacturer report # 1644487-2015-04810). Upon opening the neck incision, surgeon noted that there was not adequate strain relief from the implant surgery and this caused "pulling and twisting" of the nerve. Both the generator and lead were replaced and post replacement diagnostics were within normal limits. The explanted generator is expected to be returned but has not yet been received by the manufacturer.
 
Manufacturer Narrative 
The supplemental 04 mfr report was stated to be 09/13/2014. This was mistakenly reported and the actual date was 09/13/2015.
 
Manufacturer Narrative 

Event Description 
It was reported the hospital was able to find the explanted generator. The explanted generator was received by the manufacturer on 08/14/2015. Analysis is underway, but has not been completed to date. The explanted lead is captured in mfr. Report # 1644487-2015-04810.
 
Event Description 
Additional information was received from the explant facility that the explanted products will not be returned.
 
Event Description 
A user facility medwatch report (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient.
 
Manufacturer Narrative 
Describe event or problem; corrected data: the information regarding the return of the lead was originally and inadvertently reported in mfr. Report # 1644487-2015-04809, supplemental report #03.
 
Event Description 
Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of corrosion on the lead was previously reported in manufacturer report # 1644487-2015-04810.
 
Event Description 
It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on 08/14/2015. Analysis is underway but has not been completed to date. New information was also received stating the voice hoarseness the patient experienced was sometimes caused by stimulation.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808411
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« Reply #13 on: May 22, 2017, 09:13:19 AM »

Model Number 300-20
Event Date 01/01/2009
Event Type  Malfunction   
Event Description 
Reporter indicated that the pt was in the hosp due to a fluid build-up around his generator. The pt had both the generator and lead removed. During the procedure, what appeared to be pus was found inside of the lead, and the negative electrode had "disintegrated" as per the company representative's account. During the procedure, cultures of the site were taken and were negative for an infection, but the surgeon still believed that the fluid build-up could be due to an infection that started during the pt's previous prophylactic generator replacement surgery, as the pt had been on multiple antibiotics since the beginning of the hospitalization. During the removal procedure, it was noted that there were metallic bits within the fluid that was surrounding the generator. Attempts for more info were unsuccessful. The lead has been returned to the manufacturer, along with the metallic bits found in the fluid surrounding the generator, for analysis, but analysis has not yet been completed.
 
Manufacturer Narrative 
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization of both the generator and lead prior to distribution. Device failure suspected.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1426599
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« Reply #14 on: May 22, 2017, 09:14:45 AM »

Event Date 07/01/2013
Event Type  Malfunction   
Event Description 
Follow up with the physician found that the relationship between the event to vns was unclear, but possibly related to the delivery of stimulation. The vomiting was intermittently associated with stimulation, but was not consistent. Interventions for the vomiting and weight loss included visits to the emergency room, ax, and pylera. There was no change from these interventions; however, the patient has been doing well since surgery. There were no causal or contributory programming or medication changes which preceded the onset of either event. Per clinic notes dated (b)(6) 2012, the vns was not interrogated and the last settings remained the same. Vns diagnostics were within normal limits. Clinic notes dated (b)(6) 2013 indicate the vns was not interrogated and the last settings remained the same. System and normal diagnostic results were within normal limits.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
On (b)(6) 2013, it was reported that the patient was seen in the office that day and found to have high impedance on diagnostics. The patient complained of vomiting for the last month, which the physician associates with the patient having a vagal response. The patient's device was not disabled, as the parents do not want the device programmed off. No x-rays were taken or planned. The patient has been referred for full revision. Although no specific trauma events were reported, the physician stated that the patient has violent seizures and she believes the lead issue may have occurred during one of those seizures. Additional information was received on (b)(6) 2013 that the patient continued vomiting with weight loss, which the mother feels may be related to vns. The patient was seen in the emergency room on (b)(6) 2013 and upon interrogation, the lead output was observed to be extremely high. The patient had a full generator and lead revision on (b)(6) 2013. Review of the generator device history records confirmed all quality tests were passed prior to distribution. Of note, the patient's generator is a m105 sn (b)(4) which is associated with an internal investigation associated with charge imbalance with m105 generators. This investigation was initiated in response to a trend in lead failure events noted with patient implanted with the original model 105 generator design (e. G. Sn (b)(4)). The investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e. G. Sn (b)(4)). As a result of this charge imbalance and the low pitting potential of mp35n quadfilar coil, coil corrosion can occur resulting in a lead discontinuity. Additionally, the magnitude of this corrosion appears to be more prevalent when the generator is programmed to higher output currents. If the following criteria are met, the potential for the m105 generator design issue (only with sn (b)(4)) to have contributed to the high impedance/lead issue identified in this report is possible. High impedance (>=5300ohms) observed following interrogation or a diagnostic test. Generator is m105 with sn (b)(4). Pa identifies a lead fracture, pitting, and/or thinning of the lead coil. The device has not been returned, so product analysis has not been performed. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Event Description 
Additional information was received that the patient's device was explanted.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3321744
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« Reply #15 on: May 22, 2017, 09:16:12 AM »

Model Number 302-20
Device Problems Corrosion; Fracture
Event Date 05/01/2011
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery due to lead discontinuity on (b)(6) 2014. Attempts to have the product returned for analysis were made but were unsuccessful.

Event Description
Attempts for additional information have been made to both the patient's treating neurologist and surgeon, and no information has been made available by either site.

Event Description
Product analysis of the returned generator was completed. Visual analysis showed only observations consistent with the explant procedure; no surface abnormalities were noted on this device. The pulse generator communicated normally and the eri flag was not set. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found.

Event Description
It was reported that a patient was experiencing pain in his neck and had lost his voice. Diagnostics performed on the patient's generator showed high impedance with a dc/dc of 7. The generator was programmed to 0ma and the patient was sent for x-rays. It is unclear if the x-rays will be sent to the manufacturer for review. The patient has been scheduled to see an ent and has been referred for surgery. Surgery is likely, but has not occurred to date.

Event Description
Additional information was received that the patient would have the device explanted and go for a surgical work-up. The nurse indicated that the patient is not likely a surgical candidate, so will have a new vns implanted at a later date. No additional information was provided. Surgery is likely, but has not occurred to date.

Event Description
Additional information was received indicating that the patient has declined replacement. His device has since been disabled. Attempts for additional information have been unsuccessful to date.

Event Description
The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned portions of the explanted lead. During the visual analysis of a returned 3. 5mm portion of the negative green electrode, it was observed that the coil portion of this segment was not present. What appeared to be a greenish tint was observed inside the inner silicone tubing. This was an indication the coil had most likely dissolved and became detached from the ribbon at one point in time. Stimulation was present for a certain period of time as evidenced by the presence of greenish tint inside the inner silicone tubing. Based on the findings, there was evidence to suggest a discontinuity in the returned portions of the device. With the exception of the discontinuity, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed and no other discontinuities were identified. The set screw marks found on the lead connector pin provided evidence that, at one point in time, a good mechanical and electrical connection was present. The returned generator is undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229120
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« Reply #16 on: May 22, 2017, 09:17:36 AM »

Model Number MODEL 250
Device Problem Corrosion 
Event Date 07/28/2015
Event Type  Malfunction   
Manufacturer Narrative 

Event Description 
Product analysis for the handheld was completed and approved on 10/08/2015. An analysis was performed on the returned handheld and during the analysis it was verified that the main battery was unable to hold a charge and power the handheld. A visual analysis of the handheld and battery identified evidence that the device was exposed to fluid and corrosion was identified on the battery contacts, giving the indication that the cause for the battery anomaly is associated with mishandling of the device. Analysis for the software showed no anomalies associated with the flashcard software identified.
 
Event Description 
The hand held and software were received for analysis on 09/08/2015. Analysis is currently underway but has not been completed to date.
 
Event Description 
It was reported that the hand held had white powdery corrosion inside the battery bay. It was noted that the battery bay may have gotten wet but this is not clear. The function of the device was not affected at this time. The handheld has not been received for analysis to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5018697
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« Reply #17 on: May 22, 2017, 09:19:33 AM »

Model Number 300-20
Event Date 05/15/2012
Event Type  Malfunction   
Manufacturer Narrative 
Only a portion of the lead was returned for analysis, which did not reveal any anomalies. Device failure is suspected in the lead portion not returned for analysis, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was initially reported by a company representative that a hospital contacted him indicating a vns patient underwent surgery to replace the generator due to end of service. The implanting site indicated the patient was not replaced with a new generator as the insulation of the leads was noted to be disintegrated. The surgeon had to cut the wires, remove the old generator and close the patient. The patient was not re-implanted with vns. Additional information was received from a nurse indicating the generator was confirmed to be at end of service as communication was not possible in (b)(6) 2011. The last known good diagnostics were from (b)(6) 2011 which indicated normal functioning of the vns. The explanted generator and part of the lead were returned to the manufacturer for analysis.
 
Manufacturer Narrative 
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description 
An analysis was performed on the returned lead portions and the reported abraded insulation was not verified. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The reported end of service and low battery with their generator were confirmed in the lab; an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found with the generator.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2608683
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« Reply #18 on: May 22, 2017, 09:20:56 AM »

Model Number 103
Event Date 06/30/2009
Event Type  Malfunction   
Event Description 
It was reported that a vns therapy physician had been unable to interrogate a pt's demipulse generator and that the pt's behavior had become increasingly worse in addition to an increase in night time seizures, though not a significant increase, within the last month. The pt's mother indicated that the pt cried 75% of the day and that she was concerned that vns was causing the pt irritation or pain upon stimulation. Eventually, the pt's device was able to be interrogated and the device reportedly indicated that it was at eos and the pt's physician indicated that the pt's seizure increase was likely related to this device condition. The pt underwent generator revision surgery and the explanted demipulse generator was returned for analysis. During an external visual analysis of the device no anomalies were identified (i. E. Sharp edges, header delamination, open pockets, decomposition, corrosion or voids). Upon opening the generator case, a visual analysis identified the presence of surface contamination and foreign matter on the inside of the can weld area, the battery case, the retainer, and the pc-board. Examination also showed that in some areas the foreign matter was bridging traces and other components. The foreign matter was subjected to sem/edx for analysis. Analysis indicated that the matter was comprised mainly of tin, lead and sodium, chlorine (sodium chloride). Other trace elements were also noted. The presence of sodium and chlorine on the pc-board could potentially cause the corrosion that was observed. Additionally, no leakage was identified at the generator's battery terminals. The source of the elements could not be determined. The battery voltage measured 15. 2 mv, indicating that the battery was depleted. No further electrical testing could be performed due to the presence of damage to the pc-board from the foreign matter. The generator device history record (dhr) was reviewed; all line items were verified to have been signed off, all electrical tests/visual inspections were passed and there were no unresolved non-conformances prior to device shipment. As the corrosion of the generator was contained within the generator's canister, there was no likely interaction with the pt's extracellular environment. In the worst case scenario, the generator will no longer function properly or not be able to deliver the intended amount of therapy. It appears that the battery was prematurely depleted. The premature depletion is related to the remnants of foreign matter/corrosion that were observed on the pc-board, most likely due to presence of sodium, chlorine (sodium chloride) on pc board. Good faith attempts to obtain programming/device diagnostic history have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1921071
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« Reply #19 on: May 22, 2017, 09:22:09 AM »

Model Number 102
Event Date 11/01/2007
Event Type  Malfunction   
Manufacturer Narrative 
Conclusions: device malfunction is suspected but did not cause a death.
 
Event Description 
An implant warranty and registration card was rec'd documenting the pt had their lead replaced for a lead break and corrosion on the generator. Good faith attempts are being made for prod return and add'l info about the reported corrosion.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=975491
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« Reply #20 on: May 22, 2017, 09:23:35 AM »

Model Number 300-20
Event Date 05/16/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that the patient had diagnostics done and received high lead impedance. Per the doctor, the device remained on since patient was "stable" and did not have any increase in seizures. After being informed of corrosion with lead breaks warning per manufacturer labeling, he plans to bring the patient in and turn off the device and take x-rays. No further information is available at this time.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a serious injury or death.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236208
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« Reply #21 on: May 22, 2017, 09:24:50 AM »

Model Number 101
Event Date 01/01/2009
Event Type  Malfunction   
Event Description 
It was reported that upon replacement of a patient's generator for end-of-service, the explanted generator appeared to have corrosion. The cause of the corrosion is unknown at this time. The device has been returned to the manufacturer for analysis. The device has yet to be analyzed.
 
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1316467
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« Reply #22 on: May 22, 2017, 09:26:14 AM »

Model Number 300-UNK
Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description 
It was reported that the pt was having a battery replacement due to possible end-of-service. Pt's seizures were also slightly worse. In the or, the surgeon visually noticed that the lead's tubing seems to have completely disintegrated along the wire. Pt was re-implanted with a new generator and diagnostics results showed everything working within normal limits. Pt's leads are not explanted at the moment. Good faith attempts to obtain additional info and explanted product back for product analysis has been unsuccessful. The cause of increase in seizures is unk at this time.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1490570
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« Reply #23 on: May 24, 2017, 01:23:03 AM »

Model Number 302-20
Event Date 03/28/2008
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
Reporter indicated that during a generator revision surgery for presumed end of service, the lead was found to be "frayed" and corroded in addition to the generator (ref. Mfr. Rpt. # 1644487-2008-00934). The lead was replaced in addition to the generator. The explanted devices have been received and are currently awaiting analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1041279
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« Reply #24 on: May 26, 2017, 12:00:45 PM »

Model Number 302-20
Event Date 03/10/2009
Event Type  Malfunction   
Event Description 
Reporter indicated a vns therapy patient received high lead impedance on diagnostic testing. The patient did not manipulate the device or experience trauma. According to the patient's sister, the physician reportedly stated the lead was "corroded. " review of office notes received from the physician, the patient "was in the hospital for a break through seizure in february. " a battery life calculation revealed the generator is 1. 51 years until the elective replacement indicator reads "yes. " the patient is scheduled for surgical consult in 2009. Good faith attempts to obtain additional information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1429515
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« Reply #25 on: June 02, 2017, 09:04:39 AM »

Model Number 300-20
Device Problems Break; Difficult to remove 
Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device malfunction is suspected, but did not contribute to a death or serious injury.
 
Event Description 
It was initially reported that the pt was having replacement surgery of his generator due to normal battery depletion. However, when surgeon tried to remove the pin from the generator, the lead broke. The surgeon believes that pins could be corroded inside the generator which could have lead to the lead breakage, but this has not been confirmed. The lead and generator have been returned to the mfr for analysis, but it has yet to be performed. The pt was re-implanted with a new lead and generator.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1473824
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« Reply #26 on: June 02, 2017, 09:05:55 AM »

Model Number 300-20
Event Date 07/15/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
During a prophylactic vns generator replacement surgery, the reporter noted that the vns lead appeared corroded, kinked, and had fluid in the lead body. High lead impedance was also noted with diagnostics testing after the lead was attached to the new generator. The lead was replaced and the generator was replaced due to incompatibility with the new lead. Attempts for return of the explanted lead and generator have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1481511
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« Reply #27 on: June 07, 2017, 11:41:20 AM »

Model Number 302-20
Event Date 01/11/2010
Event Type Malfunction
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contributed to a death or serious injury.

Event Description
Reporter indicated a pt had vns lead and generator revision surgery due to high lead impedance, a lead fracture, and suspected premature end of service for the generator. The premature end of service event for the generator is being reported via mdr #1644487-2010-00280. The reporter noted during the revision surgery that the lead was eroded. The explanted lead was returned for analysis. During the visual analysis an abraded opening was observed on the outer silicone tubing. A portion of the lead assembly including the electrodes was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1604063
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« Reply #28 on: June 11, 2017, 02:29:11 AM »

Model Number 302-30
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred.
 
Event Description 
During surgery to address migration reported in mdr 16444870-2010-00430, the lead was accidently cut by the surgeon and had to be replaced. The explanted lead was returned to the manufacturer for analysis. Abraded openings and dried bodily fluids were identified in the outer silicone and the inner silicone tubing of the positive and negative lead coils. It is believed that this condition could potentially contribute to the patient "pain" allegation. However, the exact impact of this condition and when it occurred is unknown. The reported "mechanical problem/punctured insulation" allegation was verified the silicone tubing of the negative coil has a puncture. The exact point in time of when this occurred is unknown. Corrosion was also observed on the lead pin. Tie downs were observed round the lead in various locations causing some compression of the lead body. Other than the above mentioned observations typical wear and explant related observations, no other anomalies were identified within the returned lead portions.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1680404
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« Reply #29 on: July 05, 2017, 02:26:03 PM »

Model Number 302-20
Event Date 10/06/2010
Event Type Malfunction
Event Description
Reporter indicated a vns pt had recurrent swelling and pain at the vns generator site. Fluid from the site was previously aspirated, but continued to recur. Cultures of the fluid did not identify any infection, and the incision site did not appear to be infected. The pt later had exploratory surgery of the vns generator site, where it was noted the vns generator header was corroded, and the vns led pin appeared to be "soft" and the lead appeared "weakened". High impedance was obtained with a new vns generator and the resident lead, indicating a lead fracture was likely. The generator and lead were removed, and no new devices were implanted. Prior to surgery, it was noted the generator was at eos = yes, indicating generator end of svc, and vns diagnostics were unable to be completed due to the suspected depleted battery. The depleted battery is likely premature, as a battery estimate indicated over 8 yrs remaining. The premature end of svc is likely due to the generator header corrosion, and the header corrosion is likely due to the lead fracture. F/u with the treating neurologist revealed vns device diagnostics in (b)(6) 2010 were within normal limits, the pt had no known trauma, and did not manipulate the vns. F/u with the reporter revealed the pt is healing well. It is likely a new vns sys will be implanted when the pt has fully recovered. Attempts for return of the explanted devices have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1893348
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