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dennis100
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« Reply #510 on: April 06, 2019, 01:33:17 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
It was reported through social media by the mother of the patient that the patient passed away with the vns implanted. It was stated that vns did not help the patient. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8394078
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dennis100
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« Reply #511 on: April 07, 2019, 02:26:57 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2000
Event Type  Injury   
Event Description
The patient's generator was disabled after 6 months of use reportedly due to lack of benefit. It was reported that the patient's generator was explanted due to considerable irritation on the left site of their neck where the electrodes were located, which worsened when they turned their head. It was reported that prior to explant the patient's skin was puckered and that an anchor tether, part of the lead body, had poked through their skin. Another reason for explant was indicated as scar tissue, likely at the electrode site caused by chronic irritation. While the patient's generator was implanted they reported having tightened neck muscles due to vns stimulation, likely related to the lead extrusion and scar tissue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8425064
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dennis100
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« Reply #512 on: April 08, 2019, 02:29:28 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2001
Event Type  Injury   
Event Description
It was reported that the patient was referred to have their generator and lead explanted due to lack of efficacy, discomfort and the desire to have an mri (body scan). It was reported that the patient's generator had previously been disabled. 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=8381857
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dennis100
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« Reply #513 on: April 09, 2019, 12:37:35 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Event Description
The patient reported on (b)(6) 2016 that her lead is protruding and is painful because she has lost a lot of weight. She stated she lost weight and device migrated and she has a knot where she thinks the wire connected to the generator. The patient needs a mri for her left breast but the generator is right above. Follow-up with the physician showed that she needs an explant asap and it's not clear if she needs it only for the mri or for the pain, protrusion and migration too. The physician states that the pain, protrusion and migration were present before her weight loss but now the device is more prominent in her neck since her 100 lb weight loss. The mass at her connector site of the lead and generator is believed to possibly be from the lead coming loss (probably from migration of the system). From the report it seems as though the lead is protruding, painful in the neck and possibly migrating causing a mass near the generator connection. Surgery has not occurred to date.
 
Event Description
Information was received from the physician on (b)(6) 2016. It was stated that the reason for the explant was due to the need for mri for breast lump, patient was a non-responder to vns therapy anyway, and patient was experiencing pain, protrusion and migration. It was stated that the patient experienced more pain after the weight loss. The issues began 6 to 7 years ago. No surgical intervention has not occurred to date.
 
Event Description
It was reported on (b)(6) 2016 that the patient had her device explanted that day. The explanted devices were disposed of.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5834683
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dennis100
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« Reply #514 on: April 11, 2019, 02:29:53 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient was having the vns generator and lead explanted due to the generator being at end of service since 2014 and the patient being a non-responder when the generator was on. The explanted generator and lead were returned for product analysis. Product analysis on the generator found that it was at end of service and could not be communicated with. The battery's voltage was 0. 6v, the generator will no longer communicate after the battery reaches 1. 8v. Product analysis on the lead identified fractures of the quadfilar coils and abraded openings of the outer and inner tubings. It was also noted that the quadfilar coil had signs of pitting which appeared to be the result of stimulation being provided after the fracture had occurred. Review of the internal programming history database contained data up until (b)(6) 2012 where diagnostic results were within normal limits. Therefore it is known that the lead fracture occurred after (b)(6) 2012. Due to the pitting that was observed it is likely that the fracture occurred prior to the generator's end of service condition.
 
Manufacturer Narrative
Corrected data: describe event or problem; this information was inadvertently left off on mfg. Report #0.
 
Event Description
Product analysis found fluid leaks in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5791147
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dennis100
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« Reply #515 on: April 22, 2019, 01:37:33 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2016 that this patient has high impedance. No other additional information has been obtained to date.
 
Event Description
The patient had vns explant surgery, and both the generator and lead were explanted. System diagnostics were not performed prior to surgery, so the previously reported high impedance was not confirmed. Also, the explant was reported to have been due to the patient not have efficacy. Programming history did not have diagnostic results available, except from the date of implant, which were within normal limits. The explanted products have not been received to date.
 
Event Description
The explanted products were discarded. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6087789
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dennis100
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« Reply #516 on: April 24, 2019, 02:02:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2013
Event Type  Injury   
Event Description
It was reported by the surgeon the patient was going to have her vns explanted on (b)(6) 2016. The surgeon stated the patient had been implanted for over 3 years and the vns was not effective because the patient wasn't able to tolerate titrating up the vns settings. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient had requested for the device to be explanted because she didn't like it and it wasn't helping her. It was noted the device was programmed off because the patient didn't like the current, but then she just didn't like the vns. There were no issues with the vns, the patient just did not like it and requested the explant. It was later verified the patient's vns was explanted on (b)(6) 2016.
 
Manufacturer Narrative
This information was inadvertently left off of the supplemental #01 mfr. Report. (b)(4).
 
Event Description
It was later reported by the same physician that the adverse events the patient experienced during titration included pain in the neck, difficulty swallowing, uncomfortable when the current is programmed on, increased falls during her seizures, and no decrease in seizures activity. It was also noted that the patient's seizures were possibly worse with vns; however, no actual seizure rates were given.
 
Event Description
It was reported by the explanting facility that the device was discarded.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #03 mfr. Report.
 
Event Description
It was initially reported by the explanting site that the vns devices had been discarded; however, additional information was received from the site and they had requested the return number so that they could send the generator back. The generator and a portion of the lead were returned to the manufacturer. While analysis is expected, it has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis (pa) for the returned generator was completed. The device performed per functional specifications. There were no performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Note that the lead assembly (body) including a portion of the connector boot; therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned portion of the lead was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6181099
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dennis100
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« Reply #517 on: May 01, 2019, 12:47:19 AM »

Model Number 250
Device Problem Computer Software Problem
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Clinic notes were received and it was found within the notes the patient's mother did not feel the vns had done much for the patient. The nurse practitioner explained that the patient had experienced a status epilepticus event about 3 years ago when the patient's vns settings were programmed off. It was explained this occurred due to the wand being moved by the patient while the device was being checked as the patient was being uncooperative.
 
Manufacturer Narrative
Age at time of event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Date of event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
The programming history for the patient's vns generator was reviewed which did not show any points in time where the patient's device was programmed off. However, there are gaps in the available history, so an exact event date could not be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6302609
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dennis100
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« Reply #518 on: May 01, 2019, 12:48:40 AM »

Model Number 300-30
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 06/01/2015
Event Type  Malfunction   
Event Description
The patient's vns was returned to the manufacturer for an unknown reason. Follow-up with the physician's office showed the patient was explanted due to a lack of efficacy and because she wanted to be able to have mris. A battery life calculation was performed which showed the no anomalies and indicated the patient would have approximately 4. 3 years remaining until the neos = yes (near end of service) condition. The information available was only from (b)(6) 2011 through (b)(6) 2012. The programming history database was reviewed which showed no anomalies. The information available was from (b)(6) 2011 through (b)(6) 2012. Product analysis for the returned lead was completed. During analysis, a coil break was observed, along with abrasions on the inner and outer silicone tubes. Scanning electron microscopy (sem) was performed which identified the area as having extensive pitting which prevented the identification of the fracture type. Sem was then performed on the mating end of the broken coil and identified the area on three of the broken strands as being mechanically damaged with fine pitting which prevented the identification of the fracture type. The area of the remaining broken strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Flat spots and pitting were observed on the coil¿s 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 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. Additional follow-up with the physician's office showed that the patient was seen for a visit in (b)(6) 2015 and the device showed high impedance with a dcdc value of 7, which had increased from a previous value of 1. It was noted the patient's previous visit was in september of 2014 and the high impedance was believed to have occurred sometime between those dates. It was noted the patient's seizures had decreased after lacosamide was started and after the high impedance was first observed, indicating the patient did not benefit from the vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6305667
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dennis100
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« Reply #519 on: May 07, 2019, 07:13:03 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient underwent surgery to explant his lead and generator. The neurologist indicated that the reason for explant was lack of efficacy, the patient said that the vns was uncomfortable and because the patient was unable to tolerate increases in output current. The suspect product was received for product analysis. The generator's device output signal was monitored for 24 hours under a simulated body temperature environment. The device delivered the expected stimulation consistently. No anomalies were found. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the explanted lead. The majority of the lead body and the electrode array were not returned. Continuity checks were performed and no discontinuities were found. No other obvious anomalies were found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6396741
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dennis100
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« Reply #520 on: May 08, 2019, 10:25:49 AM »

Model Number 100
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was reported that the vns patient had the vns generator explanted as the device was protruding and the skin was beginning to erode. F/u with the surgeon's office revealed that they opted to explant the device to prevent any further worsening of the skin erosion so as to prevent a possible infection at the wound site. The pt's device had been programmed off for some time, as it was noted by the patient's treating neurologist that vns therapy was not providing the patient with much benefit for seizure control. There was no report of any causal or contributory pt manipulation to the device site. The exact cause of the protrusion of the pulse generator was not able to be ascertained when following up with the surgeon's office. Good faith attempts to obtain the explanted device for analysis are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845929
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dennis100
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« Reply #521 on: May 10, 2019, 01:44:17 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2003
Event Type  Injury   
Event Description
Clinic notes were received for vns removal. The notes indicated that vns will be removed as it has been off for over 5 years. The patient has been undergoing chemotherapy for throat cancer. The patient reported that the vns is bothersome as he feels it in his throat as if it is on. The device according to the patient was turned off 4 years ago for lack of efficacy. The device was interrogated during this appointment and confirmed to be off. Battery was stated to show ifi-yes (although model 101 so likely neos). Notes indicate that the patient reports erratic sensation of vns stimulation in the throat. He has seen gastroenterology who performed endoscopy and reported abnormalities in the throat. The patient does not believe the report and suspects it¿s the vns and is adamant that he wants referral for removal. The abnormalities in the throat are still be looked into. No surgical intervention has occurred to date and no additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8508514
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dennis100
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« Reply #522 on: May 11, 2019, 01:44:03 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 03/17/2010
Event Type  Malfunction   
Event Description
It was initially reported from social media post that a patient¿s son did not see any benefit from the vns device. At this point patient information was unknown. Additional information was received from the patient¿s mother which identified the patient whose vns was said to be ineffective. She said that the generator was dead and that vns had "failed" and did not help her son enough to agree to have the generator replaced. She said that the patient's physician had told her that explant would run the risk of infection and that it would be safer to keep the system implanted. The programming history database was reviewed and showed a possible short circuit condition. It appears that there was a dramatic drop in impedance from (b)(6) 2009 dcdc 2 to (b)(6) 2010 showing dcdc 0. Along with the allegation that the device was ineffective, this shows there may have been a short circuit condition present. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491506
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dennis100
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« Reply #523 on: May 11, 2019, 01:44:36 AM »

Model Number 304-20
Device Problem High impedance
Event Date 03/09/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was scheduled to have his vns generator and leads explanted. Upon follow-up it was stated that the reason for explant was due to the vns device not helping. A fax response was received for further follow-up questions from the physician's office. The physician did not provided an assessment for the patient's lack of efficacy. The last programmed settings and diagnostics were provided. It was noted that impedance was high, though no value was provided. Device history records were reviewed for the generator and lead products. Both devices passed all quality inspections prior to distribution. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557239
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dennis100
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« Reply #524 on: May 11, 2019, 01:45:07 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/24/2014
Event Type  Injury   
Event Description
It was reported that a patient wanted their device explanted as it did not help her seizure control and it was negatively affecting her sleep. Operation notes were received confirming the explant. The generator was removed, and the leads were detached form the nerve and completely removed. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8538504
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dennis100
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« Reply #525 on: May 11, 2019, 01:45:41 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for explant due to discomfort in their left upper chest and lack of efficacy. The patient¿s most recent settings and diagnostics were not available. Programming history was reviewed for the patient. There were no anomalies seen. The patient was explanted. The devices were discarded during surgery and were not available for return. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516135
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dennis100
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« Reply #526 on: May 11, 2019, 01:46:18 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2001
Event Type  Injury   
Event Description
The patient was referred for the removal of the vns device as the patient believes the device chokes the them when it stimulates. Programming history was reviewed, and the patient¿s device was disabled on (b)(6) 2002. The last diagnostics showed good impedance. No indications of a device malfunction were identified in the programming history. The patient's device had previously been disabled due to choking and coughing. Per clinic notes, the vns had not helped to decrease the patient¿s frequent seizures of having 1-2 seizures per week. The patient was also said to be having swallowing issues. A second office reported that the patient did not have any discomfort when the device was programmed off. It was reported that the patient was referred for removal in order to allow for mri imaging, however it had previously been reported that the patient was referred for removal due to the feeling of choking so the reason for the patient's removal surgery is unknown. No relevant surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514622
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dennis100
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« Reply #527 on: May 20, 2019, 09:29:49 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that the patient had three breakthrough seizures, but the physician had also stopped the patient's vimpat. Diagnostics were performed, which confirmed that the device was functioning properly. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's tie-down was protruding at the neck incision. It was stated that the patient has not had efficacy possibly from the lead being placed too low also causing side effects. It was alleged that the patient started feeling a burning sensation and vibrating in the throat with auto-stimulation. It was thought that the increase in seizures could have caused the patient to have more autostimulations than usual, which caused the burning/vibrating in the neck area. The device was then disabled in may due to the burning sensation and vibrating in throat. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the device was likely disabled around (b)(6) as the patient was seen in the emu at this time. No additional or relevant information has been received to date.
 
Event Description
Information was received indicating that the patient is scheduled for a full replacement. Surgery is likely but has not been completed to date. No additional or relevant information has been received to date.
 
Event Description
The patient underwent a full explant. It was stated that x-rays were reviewed and revealed that the device was too low and the electrodes did not appear even on the nerve the explanted devices have not been received for analysis to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566145
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dennis100
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« Reply #528 on: May 27, 2019, 11:33:38 PM »

Model Number 103
Event Date 08/03/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was not receiving efficacy from the vns device. It was later reported that the patient's mother believed the vns device was making the patient's seizures worse. The device history record for the implanted generator showed that the generator had passed all quality inspections prior to release for distribution. Post-op impedance values for the device were also within normal limits, indicating the device was working as intended after surgery. No further 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=5910302
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« Reply #529 on: May 30, 2019, 06:36:27 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 06/22/2006
Event Type  Malfunction   
Event Description
It was reported by the patient that his vns had been "non-functional" for a few years and was no longer working. A battery life calculation was performed, which did not support battery depletion as a cause of the device being "non-functional. " the patient requested to have his device explanted. Programming history showed that diagnostics were within normal limits throughout the available history. The patient's device was programmed to relatively low settings. Attempts for further information were unsuccessful to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the initial report inadvertently did not report that the devices were received. (b)(4).
 
Event Description
Clarification was received that the device being "non-functional" was actually lack of efficacy. The patient had explant surgery because she needed to have an mri performed, and the generator and lead were received for analysis. Analysis on the generator was approved. 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. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis on the lead has not been approved to date.
 
Event Description
Analysis on the lead was approved. Note that a portion of the lead assembly (body) including the electrodes was not available for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. 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. Continuity checks of the returned lead portions were performed with no discontinuities identified. There was no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610142
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« Reply #530 on: May 30, 2019, 06:37:19 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 08/26/2005
Event Type  Malfunction   
Event Description
It was reported that the vns device never worked for the patient. It was stated that it didn¿t work since after swiping the magnet they stated it did not help or lessen the seizure. The battery was reported to be depleted. A review of the manufacturer¿s in-house programming history database revealed there is evidence of fluctuating lead impedance levels, indicating a short circuit or low impedance condition. An estimate of battery life calculation was performed with the available history which indicated the battery to be depleted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6645915
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« Reply #531 on: June 02, 2019, 01:13:14 AM »

Model Number 101
Event Date 08/08/2012
Event Type  Injury   
Event Description
Patient notes dated (b)(6) 2012, were received on (b)(6) 2012, regarding this vns patient. The notes indicated that patient was seen in consult for removal of the vns. The patient had the vns placed roughly 10-12 years ago for seizures (occurring since birth). The patient was now only on keppra for his seizures. The patient had not had a grand mal seizure in a long time, but continued to have frequent petite mal seizures. The patient said he had the vagal nerve stimulator on for about a year; however, it was then turned off because he was not benefiting from the vagal nerve stimulator. Since that time, it has been nonfunctioning in his body. The patient initially did not have any problems, but noticed a few years ago that he would get collections and hard swelling at the generator site that was occasionally painful, especially after working hard. This typically resolved over the course of a night. The swelling became more frequent over the last year and now happens every day or every other day. The patient requested the device be removed due to the discomfort. No neck problems related to the lead were experienced. The patient reported that he had not had any fever, chills, or signs of infection. The patient's programming history was reviewed, and it was noted that the patient's device was disabled on (b)(6) 2003. At this time, system diagnostic results indicated high impedance. A battery life calculation performed yielded negative results. Surgery is likely, but has not occurred. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, it was reported that this vns patient underwent explant surgery on (b)(6) 2012. Attempts for product return were unsuccessful as the devices were reportedly discarded after explant. Attempts for additional information have been unsuccessful. The high impedance event is captured in mfr report #1644487-2012-02697.
 
Manufacturer Narrative
Relevant data with dates, corrected data: previously submitted mdr provided system diagnostic and programmed data for (b)(6) 2012; however, this date should be (b)(6) 2003. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2764061
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« Reply #532 on: June 03, 2019, 04:48:18 AM »

Model Number 102
Event Date 06/21/2006
Event Type  Malfunction   
Event Description
It was reported by the patient that he had been having worsening depression for about a year to a year and a half. The patient also stated that he had been having suicidal thoughts since being implanted with vns however it is unknown if these had worsened since implant or pre-existing. Per the patient, the physician had previously informed him that his vns "wasn't charged" or was "malfunctioning" however he did not have any further information. The patient stated that he still feels stimulation and that it has not changed at all so he did not believe there was an issue with the battery. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received indicating the patient wants to have his vns explanted. The patient noted that the vns did not help his depression. The patient confirmed the physician indicated to him that the "vns was not working anyway. " the patient intends to pursue explant of the vns however it is unknown if it will occur at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355590
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dennis100
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« Reply #533 on: June 11, 2019, 12:57:19 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
It was reported that the pt's device was disabled in 2009 and has been off ever since because she did not feel that it helped her. Pt would like her device explanted. Pt also reported that she feels "something is loose in her device". Xrays were performed and reviewed by physician, but everything looked normal. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2271417
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dennis100
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« Reply #534 on: June 15, 2019, 11:19:12 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for an explant of the vns device. It was stated that the vns was not working for the patient. Only the generator was explanted. Follow-up revealed that the vns had been off for a while and it was painful. Due to the explanting facility's protocol, the generator is not available for return and analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7024410
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dennis100
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« Reply #535 on: June 18, 2019, 12:40:56 AM »

Model Number 102
Event Date 05/27/2014
Event Type  Death   
Event Description
The physician reported that the patient was receiving vns therapy at the time of death and that the patient experienced no change in seizures with vns therapy.
 
Event Description
The hospital mortuary reported that the vns patient passed away. The cause and circumstances of death are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
New information received corrects the date of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3894897
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dennis100
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« Reply #536 on: June 28, 2019, 10:37:53 PM »

Model Number 102
Event Date 07/27/2013
Event Type  Injury   
Event Description
It was reported that the patient was experiencing chest pain and underwent device explant. It was also reported that the patient did not experience efficacy with vns therapy. It was reported that the patient's device was programmed off on (b)(6) 2013. Device diagnostics were within normal limits. It was reported that the patient had complained of chest pain that had been occurring for 3 days. The patient noted significant relief from the chest pain when the device was programmed off. It was also reported that clinic notes dated (b)(6) 2013 noted migration of the device and because of the patient's chest pain the patient was referred for surgery because the neurologist thought there may be an issue with the device. It was noted that the patient was seizure free since the device was programmed off so the patient's family asked for device explant with no plans to reimplant. The explanted generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the majority of the lead assembly (body) 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. 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 an anomaly with the returned portion of the device which may have contributed to the stated complaints. Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4055314
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dennis100
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« Reply #537 on: July 01, 2019, 10:13:35 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 11/01/2004
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day. The patient also reported that his left arm felt heavy and numb. Follow up with the patient's neurologist revealed that the neurologist was unaware of the events. During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics. The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance. No additional information has been received to date.
 
Event Description
It was reported that the patient's mother felt that the vns had never really helped the patient with his seizures and that she did not want the vns replaced. It is unknown whether the lack of efficacy was related to the possible low impedance. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7529711
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dennis100
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« Reply #538 on: July 05, 2019, 10:18:39 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/29/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient underwent vns explantation surgery due to an unknown reason. Follow up with the surgeon revealed that the patient wanted the device explanted as the patient felt that the vns was not beneficial and was typically associated with side effects. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8698477
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dennis100
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« Reply #539 on: July 16, 2019, 11:12:08 PM »

Model Number 101
Event Date 10/02/2000
Event Type  Injury   
Event Description
It was reported that the patient had cognitive changes and starts to act semi-violent at higher settings, and that the benefits of the vns therapy is not noticeable. The physician was contacted for additional information but no response was received to date. It was also reported that the patient's vns device will be explanted, but the date of surgery is unknown to date.
 
Event Description
It was reported that the patient had the vns generator and the lead explanted. It was confirmed that the vns generator and lead will not be returned to the manufacturer.
 
Event Description
New information was received from the surgeon indicating the electrode array portion of the lead was not removed from the vagus nerve, and remains implanted in the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967740
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