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dennis100
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« Reply #420 on: July 29, 2018, 07:25:51 AM »

Model Number 102R
Event Date 08/14/2012
Event Type  Death   
Event Description
Additional information was received from the treating physician which revealed that the believed cause of death was sudep. The patient exhibited risk factors that would make him more susceptible for sudep, but the details were not mentioned. Per the physician, the death was not related to vns therapy. The patient did not respond to vns therapy. The patient was not receiving vns therapy treatment at the time of death, as the generator was previously explanted on (b)(6) 2011, due to the infection as previously reported in manufacturer report number: 1644487-2011-02017. It was reported that the patient's leads were not explanted after death. No autopsy was performed, and the death was not witnessed as the patient found at home in bed. The explanting facility reportedly does not have the explanted generator from (b)(6) 2011.
 
Event Description
It was reported by the patient's caregiver that the vns patient died on (b)(6) 2012 due to an unknown reason. The patient's generator was previously explanted on (b)(6) 2011 due to an infection, as reported in manufacturer report number: 1644487-2011-02017. Plans for reimplant were postponed in (b)(6) 2012 because the patent was hospitalized with a bowel obstruction. Since the patient was explanted for infection and the cause of death is not known at this time, it is unknown if the death was related to the infection in any way. The company representative followed up with the treating physician who reported that she did not have additional information on the patient. However, a copy of the death follow up form was provided to her. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Corrected data: the supplemental report #1 inadvertently did not include the updated conclusion. No device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2746980
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dennis100
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« Reply #421 on: August 07, 2018, 01:20:07 PM »

Model Number 104
Device Problem No Known Device Problem
Event Date 05/04/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by manufacturer, device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy).
 
Event Description
It was reported that a patient is at ifi-yes and wants the device explanted because it irritates her. She was seen in clinic and ifi-yes was seen for referral for explant was sent to discuss explant. The patient does not want it re-implanted as it irritates her and wants it out. The neurologist has been tapering the vns settings down at each office visit. No additional or relevant information has been received to date. Surgical intervention has not occurred to date.
 
Manufacturer Narrative

Event Description
Follow-up information revealed that the patient was bothered that she couldn't get an mri because of her vns so wanted it out, as she doesn't think it was effective. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7560776
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dennis100
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« Reply #422 on: August 08, 2018, 12:46:38 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type  Injury   
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.
 
Event Description
It was reported that a vns patient was experiencing painful and erratic stimulation for about three months prior to an appointment on (b)(6) 2016. She stated that her autostimulations were going off "constantly and painful" at times, particularly at night. The provider changed device settings comfort measures. The device was then disabled. It was later provided that explant surgery was scheduled. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.
 
Event Description
Follow-up from the provider indicated the reason for explant was that the patient did not think the vns helped.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6953908
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dennis100
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« Reply #423 on: August 10, 2018, 03:38:39 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Malfunction   
Event Description
It was reported that the patient had been seizure free for about 4 months after his vns was implanted, but then he started having tonic seizures again. The patient's mother reported that she started seeing behaviors associated with other types of seizures that the patient had not had in the past, such as long naps. The rate of the seizures was reportedly the same as the past. The patient's device was checked, and diagnostics were within normal limits. The physician stated that the device was functioning properly, and the programming was done as normal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7714233
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dennis100
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« Reply #424 on: August 10, 2018, 03:39:23 AM »

Model Number 303-20
Device Problems Mechanical Problem; Device Contamination with Body Fluid
Event Date 01/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Product analysis of a returned lead identified two abraded openings with the lead wire exposed. The abraded openings most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner and outer tubing. The likely cause of the abraded openings were wear. No further anomalies were identified. Note that the patient's generator had been disabled approximately three years prior because it was not felt that the vns was no longer needed as the patient's seizures were controlled by medications and there was a question of device efficacy for the patient. The patient was explanted for comfort reasons unrelated to stimulation. Product analysis was completed on the returned generator. The patient's generator battery status was near end of service. The generator was found to perform as intended. Review of the generator's internal data showed that the last >25% change in impedance prior to device disablement indicated normal impedance values. The generator does not perform 24 hour impedance checks while the device is disabled. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7697311
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dennis100
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« Reply #425 on: August 11, 2018, 12:48:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2011
Event Type  Injury   
Event Description
It was reported that the patient wanted the vns device to be explanted due to voice hoarseness and device not working (lack of efficacy). The patient complained of hoarseness and feels like she is getting a sore throat at times, so she uses the magnet to turn it off. Settings were adjusted to help with the hoarseness follow-up with the physician reveals that the hoarseness and sore throat are related to vns stimulation. No causal or contributory programming or medication changes precede the onset of the events. No patient manipulation or trauma occur that is believed to have caused or contributed to events. No known surgical intervention have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7692430

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dennis100
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« Reply #426 on: August 26, 2018, 01:58:13 AM »

Model Number 300-20
Device Problem Fluid Leak
Event Date 02/06/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported via operative notes received several years after the surgery that fluids were identified within the patient's vns lead. This was observed during a vns generator implantation surgery. The patient had previously been explanted due to lack of efficacy and wished to retry vns therapy. During the implant surgery, it was noted that the lead appeared to contain fluid, which was previously unreported to the manufacturer, and resulted in the lead being replaced. The explanted products were received by the manufacturer. Lead product analysis was completed. An abraded opening was noted on the vns lead outer tubing. Scanning electron microscopy, or sem, of the mark and unmarked connector pins at the areas with an opaque appearance indicated that the pins were in contact with some type of electrocautery tool. This condition was likely caused at explant. The lead was returned in three portions. Since the lead portion containing the electrodes was not returned, evaluation and assessment as to that portion could not be made. No discontinuities were identified in the returned lead portions. The lead connector has what appears to be a cut or tear opening at approximately 3. 7 cm from the end of the marked connector boot. A portion of the positive lead coil was protruding from the cut/tear opening, forming a loop. The lead connector appeared to have been torn at the connevtor bifurcation, resulting in a portion of the coil exposed. The outer silicone tubing had an abraded opening at approximately 21. 7 cm and a puncture opening approximately 20. 6 cm from the end of the connector bifurcation. Dried remnants of body fluids were identified in the inner and outer silicone tubing with no other obvious points of entry than the noted openings and end of the returned lead portions. Based on the appearance of the returned portions, it was believed that the identified puncture was likely caused during explant. Other than the above mentioned observations and typical wear and explanted related observations, no other anomalies were identified in the return lead portions. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7390047
« Last Edit: June 28, 2019, 10:36:04 PM by dennis100 » Logged
dennis100
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« Reply #427 on: August 30, 2018, 11:46:05 AM »

Model Number 102
Event Date 01/01/2008
Event Type  Malfunction   
Event Description
Reporter indicated a pt felt the vns had been of no benefit to her and desired explant of the device. All attempts for further info from the reporter regarding the lack of efficacy have been unsuccessful to date. Explant surgery is planned for 2008.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1046611
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dennis100
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« Reply #428 on: September 07, 2018, 10:10:55 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/28/2005
Event Type  Injury   
Event Description
It was reported through clinic notes that the patient's generator had been disabled 6 months post-implant was never turned back on. The notes also report increased seizures after implant, the notes also indicated that the patient tried vns for 6 months, but there was no noticeable difference so it was turned off. The patient's clinician checked the patient's device at the time of this report; the device was still disabled and impedance was ok. The manufacturer's programming history database indicated that the patient's normal mode output current was disabled approximately 2 years after implant and that their generator was completely disabled approximately 4 and a half years after implant. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7779875
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dennis100
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« Reply #429 on: September 07, 2018, 10:09:33 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/23/2018
Event Type  Injury   
Event Description
It was reported on (b)(6) 2018 that the patient would like the vns removed as it wasn't working for him due to tolerability issues. Information was received that the patient was referred to the surgeon that implanted the device in order to explant. The patient wants the vns removed as he says it never really worked for him and now it¿s dead. No additional or relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7793278
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dennis100
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« Reply #430 on: September 07, 2018, 10:10:10 PM »

Model Number 101
Device Problem Output Problem
Event Date 07/08/2002
Event Type  Malfunction   
Event Description
It was reported that the patient underwent vns explantation surgery due to lack of efficacy. The explanted products were received by the manufacturer. Generator product analysis was completed. The reported lack of efficacy could not be evaluated in the product analysis, or pa, lab however, the observed depleted battery could have been a contributing factor. It was observed that the supply current pulsing was out of specification during the post burn test. Analysis indicated that during manufacturing, the r35 resistor was not optimally chosen. A lower value resistor would have more suitably centered the currents within the limits. With r35 reselected in the pa lab, the device performed according to functional specification. The 2,868 o resistor was replace with a 2,671 o resistor and test specifications were met. The out of specification supply current pulsing could have potentially been a contributing factor to the end of service condition. However, the results of the battery longevity calculation indicated the eos condition was an expected event. The lead product analysis will not be reported as it was not relevant to the out of specification generator resistor. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7823794
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dennis100
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« Reply #431 on: September 07, 2018, 10:10:41 PM »

Model Number 100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2002
Event Type  Injury   
Event Description
The patient's device was explanted in 2002. Information was received from the neurosurgeon that the vns did not improve the patient's seizures. According to the patient her epilepsy may have worsened. Both the generator and lead were explanted. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7797576
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dennis100
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« Reply #432 on: September 07, 2018, 10:11:56 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she wanted the vns lead removed due to high blood pressure. The vns generator was previously explanted to lack of efficacy, but the lead had remained implanted. The patient stated that she was experiencing baroreflex nerve damage and believed it to be due to the presence of the lead. The patient reported following up with physicians and all of the physicians believed that it was not related to the vns lead. The patient stated that this was only a recent issue and that she did not believe it was related to the surgery. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7819434
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dennis100
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« Reply #433 on: September 08, 2018, 12:35:50 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Malfunction   
Event Description
The patient reported that they are having very frequent "black outs" but is unsure if they are seizures or not. The patient has indoor cameras and when reviewed , there is no outward appearance of seizures, but it was stated that they just appear to be dead on camera, and the patient's latest blackout lasted for several days. The patient recently had a fall during one of the blackouts. The patient stated that the vns has never helped her. Additional information was received from the patient's previous neurologist who stated that they have not seen the patient since 2014, and there was no mention previously of the patient's black out events. It was stated that there is mention in the notes that the patient's vns stimulation was increased in (b)(6) 2013. It was stated that they didn't have any additional information. The patient reported that they have not seen a neurologist in over 3 years, and is currently only seeing their pcp. The patient is experiencing an increase in seizures which was described as dropping back as though dead where the patient is unconscious. The patient stated that she recently went to the er in response to one of these seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7792799
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dennis100
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« Reply #434 on: September 13, 2018, 02:17:11 AM »

Model Number 102
Event Date 01/24/2006
Event Type  Injury   
Event Description
It was reported that the vns patient has been experiencing shortness of breath since being implanted and it had been progressively been getting worse. It was also noted that vns therapy is not believed to have helped with the patient's depression. The patient's vns has not been checked in the past year as per the patient. The patient's psychiatrist has referred her for surgery to explant the device. Attempts for additional information including if interventions will be taken to preclude a serious injury have been unsuccessful to date. No device failure is suspected at this time.
 
Event Description
It was reported that the patient had her vns device explanted. The exact date of explant was unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069275
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dennis100
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« Reply #435 on: September 19, 2018, 01:16:55 PM »

Model Number 102
Event Date 02/20/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012. A nurse with the patient's physician indicated that there was no suspected device failure and the generator was programmed off a while ago due to a lack of efficacy which was a believed to be related to the patient being a non-responder. She indicated that she didn't know when exactly it was disabled, but it was a while ago and again re-iterated that there was no suspected device issue; therapy just didn't work for the patient.
 
Event Description
It was reported to the manufacturer that the patient's device was disabled and is not functioning. Attempts for additional information regarding what was meant by "not functioning" have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2497229
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dennis100
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« Reply #436 on: September 23, 2018, 02:47:33 AM »

Model Number 103
Event Date 02/07/2012
Event Type  Malfunction   
Event Description
The site feels the patient not feeling their stimulation is related to their high impedance and seizures are possibly related, but still under investigation at the site. X-rays were received for review. The generator is present in the left chest. The lead wires appear intact at the connector pin. However, the connector pins do not appear to be fully inserted in the x-ray images provided. It appears that one feedthru wire may be bent, but since there is only one angle of the x-rays with the feedthru wires visible, it is unable to be assessed whether the wires are intact. The electrodes appear to be in the correct orientation, but the strain relief is not placed per labeling. A strain relief bend is present, however no strain relief loop is present. The first tie-down is placed lateral to the anchor tether, and the second tie-down is placed lateral to the strain relief bend. However, there is no tie-down securing a strain relief loop. There is a portion of the lead not visible upon the superior portion of the generator, so continuity in that portion of the lead cannot be assessed. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is possibly attributed to the connector pin not being fully inserted into the connector block but unable ot be confirmed as only one view reviewed. In addition, it cannot be assessed whether the feedthru wires are intact. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out. Surgery has not been scheduled at this time.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. A lead pin not being fully inserted into the header of the generator cannot be confirmed. Additionally filter feedthrough wires could not be assessed fully.
 
Event Description
Device history review was performed and all items signed off on prior to distribution.
 
Event Description
The patient had full revision surgery performed on (b)(6) 2013. Their explanted products have not at this time been returned for analysis.
 
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that since the patient's vns has been disabled the patient has been having an increase in seizures. The patient will have surgery scheduled to check the lead pin and possibly a full revision. Unknown at this time if the battery will be replaced. At this time no surgery date is set.
 
Event Description
An update was received in regards to the patient. Their device has been disabled for about a month, and is going to be left off for now. The family feels the vns may not be beneficial for the patient's seizures; however, their treating physician feels it is beneficial since their medication has been increased since the high impedance/device disablement occurred. Since the family feels it has not been beneficial, they have elected not to have the patient's device replaced at this point. In three months, the patient will have an eeg to evaluate if anything has changed. At that point, it will be decided if a replacement will occur.
 
Event Description
The generator was returned for analysis. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 951 volts, (not at ifi) as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 41. 803% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 88mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Visual analysis was performed and identified evidence of pitting and deposits on the surface of the connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The condition of the remaining portions of the returned lead is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portions 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 discontinuities in the returned portions of the device. Note that since the electrodes array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
A vns treating physician reported that their was a vns patient showing high lead impedance on his generator. When system diagnostics were performed (high lead impedance >10000 ohms) was noted. The patient's device was disabled at that time and they were referred for x-rays. The physician reviewed the x-rays and didn't notice anything. At this time they have not been sent to the manufacture for review. The patient is a wrestler at school and specifically noted that on (b)(6), he got a really strong jolt twice in the neck while wrestling. The patient now reported that he could no longer feel the stimulation during normal mode and magnet mode, but when did a magnet swipe in the appointment, he had some voice alteration, which is normal for him. The physician initially believed that the patient wasn't getting any efficacy from the therapy since there wasn't a change in the seizures, but since (b)(6), the patient has had an increase in his grand mal and petit mal seizures (baseline above). The parents feel that the patient was receiving efficacy from the therapy. No surgery is planned at this time.
 
Manufacturer Narrative
Suspected medical device: 1, 2, 4 corrected data: updated to generator information. Device manufacture date (mo/day/yr) corrected data to generator information.
 
Event Description
The patient's explanted lead was returned for analysis and is pending completion. It was noted that it was reported that their lead was broken and the patient was having a shock sensation in their neck on the return product form.
 
Manufacturer Narrative

Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2527830
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dennis100
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« Reply #437 on: October 05, 2018, 01:24:53 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
It was reported by the patient's spouse that they were tricked about the patient's vns. The vns had not worked for the patient, and it only caused the patient damage. The patient's seizures continue either the same or worse. Reportedly, the patient was taking more medications than he did before the vns. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7905875
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dennis100
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« Reply #438 on: October 06, 2018, 06:43:07 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/04/2015
Event Type  Death   
Event Description
It was stated from the funeral home that the patient was buried with the vns device still implanted. The cause of death as stated from the county coroner on the patient's death certificate was listed as "epileptic seizure. " no additional relevant information has been received to date.
 
Event Description
It was reported on (b)(6) 2015 that a patient passed away on (b)(6) 2015 due to definite sudep. No other information has been obtained to date.
 
Manufacturer Narrative
 
Event Description
On (b)(6) 2016, the patient death follow-up form was received from the physician. The form indicated that the patient had no response to vns therapy over the course of treatment. The physician stated that the cause of death was not related to vns therapy, but had no copies of the death certificate available. The form stated, she was found lying face down in bed unresponsive. Cpr initialed unable to resuscitate. Awaken earlier per husband.
 
Event Description
An abstract associated with late-onset lennox-gastaut syndrome was received. Within the article it was noted that one patient died of sudep; however, it is unknown whether or not this patient was implanted with vns, so the sudep will be investigated in this file. Additional information was received which identified that the sudep death was the same patient as in this report. The physician stated the death was sudep and not related to vns as the patient had severe epilepsy. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5264030
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dennis100
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« Reply #439 on: October 09, 2018, 01:25:27 PM »

Model Number 103
Event Date 07/05/2012
Event Type  Death   
Event Description
With the available information the patient's death is a possible sudep.
 
Event Description
Additional information was received that the cause of death was due to seizure disorder with other significant contributing factors of atherosclerotic cardiovascular disease, diabetes mellitus, hypertension history and thyroid disorder. The manner or death was natural.
 
Manufacturer Narrative

Event Description
Additional information was received from the physician on (b)(6) 2012. It was indicated that the relationship of the patient's death to vns was unknown as was the cause. An autopsy was performed; however, the physician did not have a copy to send to the company. Additionally per the physician, vns had not helped the patient's seizures. Follow up with the patient's funeral home found that the patient was cremated and device explanted; however, as they no longer had the device, they assumed it was discarded. A request has been made to obtain a death certificate; however, per (b)(6) the cause of death is not yet available. No further information is known at this time.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was reported that a patient who was recently implant in (b)(6) 2012, passed away on (b)(6) 2012. The cause of death is unknown, however it was indicated that the death was sudden. Attempts for additional information are underway.
 
Event Description
Programming history was reviewed. Diagnostics from the date of implant are within normal limits. The device was implanted in (b)(6) 2012, and the device was programmed to deliver therapy on (b)(6) 2012. Settings were increased on (b)(6) 2012 and again on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2690445
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« Reply #440 on: October 10, 2018, 02:50:39 AM »

Model Number 302-20
Event Date 08/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated that the events began on (b)(6) 2012. Additional information was received that the problems have been occurring for almost a year. This report is being submitted to correct this information.

Event Description
On (b)(6) 2012, a fax was received from the physician's office. The fax indicated that the painful stimulation at the generator site and the partial paralysis were related to vns. The patient's device was disabled as an intervention, and explant is planned. The patient denied any trauma. No programming history was available as the patient was implanted at another site. The patient did not have a medical history of paralysis; however, it was noted that the patient had a cva prior to vns. The patient had not been evaluated by an ent. The patient wished for the device to be explanted due to pain and paralysis. The device was reportedly not working due to the patient experiencing pain. The patient's mother reported that device was inconsistently on and off. Surgery is still likely, but has not taken place.

Manufacturer Narrative
Review of additional programming history.

Event Description
On (b)(6) 2012, this vns patient reported increased seizures, generator migration, partial paralysis, shocking generator, and jumping in the neck. The patient's physician believed that the temporary paralysis was due to the consecutive seizures, not vns. On (b)(6) 2012, the patient's family member reported that the patient was last seen by her physician three weeks prior to (b)(6) 2012. The family member stated that the patient needed the device disabled due to migration and pain and requested assistance finding a closer physician. On (b)(6) 2012, it was reported that the patient had a mini-stroke and needed an mri. Attempts for additional information are underway.

Event Description
On (b)(6) 2013, the patient was seen for consult for surgical removal of the device. The patient apparently some issues regarding pain and migration of the generator around the left breast area. The wound appears to be well healed in the cervical and pectoral area, and no infection appears to be present. Nonetheless, the implant is not helping her. The device was currently disabled. Surgery is likely but has not taken place. Review of additional programming history showed that the pt's's device was disabled on (b)(6) 2012. A system diagnostic from (b)(6) 2012 indicated normal results.

Event Description
On (b)(6) 2012, the physician's office reported that the patient wanted her vns explanted. On (b)(6) 2012, follow up with the physician's office revealed that the patient wanted the device explanted because she was being evaluated for a stroke, and the device was not working properly. The office could not clarify what was meant by "the device was not working properly. " the patient just wanted the device out, and the physician was agreeable to that. The patient was first evaluated in the office on (b)(6) 2012. The paralysis was on the left side of the patient's body. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

Event Description
On (b)(6) 2012, this vns patient reported that her physician stated that something was wrong with the wiring at the patient's (b)(6) 2012 appointment. The patient did not have specifics about the issue with the wiring but reports that the physician did run tests on the device. The tests and results are unknown. The patient reported that she was experiencing generator protrusion, generator migration, lead body protrusion, numbness on the left side of her body, pain at the chest/generator site, and painful stimulation. The patient said she never had any issues prior to this. The patient also reported that she does sometimes fall but cannot associate any specific incident prior to the start of the adverse events. It was reported that an order had been sent in for x-rays; however, attempts for any additional information have been unsuccessful to date.

Manufacturer Narrative
Adverse event or product problem, outcomes: corrected data: previously submitted mdr stated that the reported event was a malfunction. Additional information was received indicating that a serious injury requiring intervention occurred. This report is being submitted to correct this information.

Manufacturer Narrative

Event Description
On (b)(6) 2012, this vns patient called complaining of a shocking sensation and generator movement. Attempts for additional information have been unsuccessful to date.

Event Description
On (b)(6) 2012, this vns patient reported that she wanted her generator explanted. She stated that the device had been causing her problems for almost a year. She stated that it is not sitting in the pocket like it should be, and when she lies down, it "floats up" causing discomfort. She stated that she had a mini stroke a few months ago and around the same time, her device was turned off because it was shocking her. She stated that about 4-5 months ago, she was to have her explant scheduled, but it just had not happened. She had spoken with the surgeon in regards to her discomfort and was told that she doesn't have enough tissue in the area where she is implanted which may be the cause for the discomfort. She stated she had not experienced any manipulation or trauma that may have caused either the migration or the shocking sensation. Surgery is still likely, but has not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2554727
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dennis100
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« Reply #441 on: October 10, 2018, 02:52:26 AM »

Model Number 302-20
Event Date 02/13/2012
Event Type  Malfunction   

Event Description
Additional information was received indicating the patient is being scheduled for explant of the vns lead and generator because of the previously indicated lead fracture, the patient's mother feels the vns did not provide benefit, and the mother reportedly does not like the appearance of the lead as it was protruding beneath the skin. The patient's physician feels the vns was beneficial for the patient. The protrusion was believed to be related to the placement of the lead during surgery and per the neurologist is "normal. " surgery has not occurred at this time but is likely.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted devicex-rays reviewed by the manufacturer, a lead discontinuity was seen however it is unclear which set of electrodes it belonged to. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received indicating the patient had her vns generator and a portion of the lead explanted on (b)(6) 2012. The electrode portion of the lead remains implanted. Attempts for the return of the explanted products were unsuccessful as the site indicated they had been discarded.

Event Description
It was reported on (b)(6) 2012 that a vns patient has high lead impedance which was first observed on (b)(6) 2012. The specific test results were not provided. X-rays were taken and sent to the manufacturer for review. The lead pin was verified to be fully inserted into the generator cavity. There were two sets of electrodes present (one from a previous vns device) and there was a lead fracture seen however due to the location it was unclear if this was from the previous electrodes or from the electrodes that are currently delivering stimulation. Good faith attempts to obtain additional information were unsuccessful to date.

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=2564863
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dennis100
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« Reply #442 on: October 15, 2018, 11:32:05 AM »

Model Number 102
Event Date 01/23/2009
Event Type  Injury   
Event Description
Initial reporter indicated that his wife, got implanted 2 years ago for depression and she has not received any benefit from the vns. He additionally reported that they have not noticed a difference in her mood. He stated "if anything it has gotten worse, she still cannot function properly in life. " it is unk if the pt's depression is above their pre vns rate. Good faith attempts have been made for further info and thus far no further info attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1329208
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dennis100
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« Reply #443 on: October 26, 2018, 11:05:03 AM »

Model Number 102
Event Date 09/26/2012
Event Type  Malfunction   
Event Description
Additional information was received that the patient had a surgical consult and she was told that her vns does not need to be replaced. Therefore no interventions are planned.
 
Event Description
Good faith attempts have been made and no further information has been attained.
 
Event Description
A vns patient called and reported that she doesn't feel like there is very much knowledge re: vns. She wants to have her vns explanted. She reports that she had a major seizure and was knocked unconscious with a confirmed concussion at her residence and taken to (b)(6). She now needs assistance moving around whereas she didn't before. Patient states was diagnosed with rhabdomyolysis and was concerned about the vns causing this. She was going for a referral for removal as she simply has had many questions about vns and some of the events she is experiencing and has not had adequate answers and this is one way she is able to ask the questions. She states she does receive efficacy from vns however, she doesn't know what happened with vns when she had her seizures and got a concussion. The patient states this happened, "same time last year". The patient reports she will occasionally have seizures however, none requiring hospitalization. Good faith attempts are underway for further information about the reported events. Thus far no further information has been attained.
 
Manufacturer Narrative

Manufacturer Narrative
Date received by manufacturer (mo/day/yr) corrected data. Supplemental 02 should have had the date (b)(6) 2013 not 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2802003
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dennis100
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« Reply #444 on: November 05, 2018, 11:19:46 AM »

Model Number 303-20
Event Date 12/21/2010
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 contribute to a death or serious injury.
 
Event Description
On (b)(4) 2012 product analysis was completed on the vns patient's generator that had been explanted due to lack of efficacy. Product analysis revealed that the intensified follow-up indicator (ifi) was set to "yes". The intensified follow-up indicator (ifi) condition is uncharacteristic for the percentage of battery consumed value of 25. 940%. Further review revealed that the explanted generator was returned with the output current programmed to 1. 50 ma. The programming history shows a high (>= 10k ohms) impedance occurrence on (b)(6) 2010 and remained until received into decontamination on (b)(6) 2012 (generator output current programmed to 0. 0ma). The combination of a high impedance value and output current setting required a "vboost" compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v); longevity estimates are not guaranteed at compliance voltages greater than 10. 5v. In this situation a significant amount of additional current consumption exists, based on the need for a component to remain on (asic remains in a trickle charge state) in order to support the higher electrical load demand. This condition contributes to the disparity between the ifi condition and percent battery capacity that has been consumed, based on the device's internal eos projection system. Other than the noted error, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the programming history dated (b)(6) 2010 showed high impedance during a normal mode diagnostics test; output=low/lead impedance=high/current delivered=0. 75ma/impedance value=7210ohms/4. 4years. The patient was programmed to output=1. 5mafrequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. A system diagnostics test performed on (b)(6) 2011 also showed high impedance with output=low/current delivered=0. 25ma/lead impedance=high/impedance value>=10,000ohms/3. 3years and the patient was still programmed to output=1. 5mafrequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. Product analysis on the lead revealed that 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 condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional 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, with no discontinuities identified. What appeared to be remnants of dried body fluids were observed inside one of the bilumen tubes. Good faith attempts for further information from the physician regarding the high impedance were made but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2856813
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dennis100
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« Reply #445 on: November 06, 2018, 07:18:04 AM »

Model Number 300-20
Event Date 11/10/2008
Event Type  Malfunction   
Event Description
It was initially reported that the patient does not use vns anymore. Review of the in house programming/diagnostic database revealed that high lead impedance was detected on a system diagnostic test on (b)(6) 2008. The device was subsequently turned off on this date. Attempts for additional information from the programmer on (b)(6) 2008 have been unsuccessful. The programmer was a physician's assistant, per the programming/diagnostic database information. Follow-up with the physician's assistant reealed that she has never seen the patient and does not know anything about the patient. She is unable to provide additional information. The treating physician is no longer a physician at the facility. Attempts are in progress to medical records for additional information but have been unsuccessful to date.
 
Manufacturer Narrative
Suspect medical device expiration date, corrected data: the initial report inadvertently reported the expiration date incorrectly. Device manufacture date, corrected data: the initial report inadvertently reported the manufacturer date incorrectly.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2008 were received from the medical records department which revealed that since the patient's last visit, the patient remained seizure free. The prior summer, the patient was having recurrence of seizures following a hemispherectomy in (b)(6) 2002 and was admitted for eeg monitoring which showed no seizure activity at that time, but had since remained seizure free since (b)(6). There was no indication that the breakthrough seizures were related to vns in any way. Lead diagnostics of the vns system showed high impedance. The physician provided the patient's family two options: taking an x-ray to make sure the lead wires were intact or the vns would need to be turned off or turning off the vns as the family feels vns was never been effective in controlling the patient's seizures. This was verified by the history available in the manufacturer's programming database. The family elected to turn the device off as they felt it was never effective in controlling her seizures. The patient's medication was also tapered on this date.
 
Event Description
Additional information was received from the treating hospital health information (medical records) department indicating that the patient's clinic notes and records will not be released due to patient signed released being required. The treating pa did not have any information and the treating physician at the time no longer works at the facility. Therefore, it was requested to follow up with the medical records department for information.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2919063
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dennis100
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« Reply #446 on: November 08, 2018, 01:32:32 AM »

Event Type  Malfunction   
Manufacturer Narrative
"the use of repetitive transcranial magnetic stimulation and vagal nerve stimulation in the treatment of depression. ".
 
Event Description
It was reported a vns therapy pt did not receive any benefit from vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019637
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dennis100
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« Reply #447 on: November 09, 2018, 02:18:38 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported by the patient that the vns had never helped with her depression and was now starting to shift around in her chest. Follow up with physician's office revealed that the vns hadn't worked for sometime, which was determined to be a reference to the reported lack of efficacy, and that the device was irritating the patient as it was moving around in her chest. The patient wanted the vns removed. The patient was scheduled for vns explantation surgery. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7957067
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dennis100
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« Reply #448 on: November 09, 2018, 02:19:09 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported via social media comment by the patient's wife that the vns did not work for her husband and was removed due to his body rejecting it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7923826
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« Reply #449 on: November 10, 2018, 02:33:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient did not think the vns was helping with seizure control and therefore the device was turned off in (b)(6) 2018. Now the patient is having pain on the left side of their neck and chest and therefore would like the device removed. Multiple attempts for relevant information were made, but no information has been received to date. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921839
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