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dennis100
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« Reply #1140 on: January 10, 2019, 02:08:50 AM »

Model Number 105
Event Date 04/28/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during the patient's initial implant surgery on (b)(6) 2014, there were difficulties identifying the nerve due to a structure with a similar appearance. Therefore, following placement of the electrodes on the structure believed to be the vagus nerve, the patient¿s generator was programmed on (output current - 2ma) in an attempt to induce bradycardia and therefore identify if the electrodes were indeed on the vagus nerve. Bradycardia was observed as intended and resolved without intervention. Therefore, it was concluded that the electrodes were properly placed. The generator was inadvertently not programmed off after the tests were completed due to communication difficulties with the programming system. As a result, the patient experienced painful stimulation, neck muscle spasms, and severe coughing until the surgeon programmed the patient's generator off and administered morphine the following day.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3825172
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dennis100
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« Reply #1141 on: January 15, 2019, 03:05:51 AM »

Model Number 302-20
Event Date 04/15/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent revision surgery. Follow-up with the implant facility revealed that the explanted product was discarded following surgery.
 
Manufacturer Narrative
Explant date; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. Evaluation codes, conclusions; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. It is unknown if the explanted device was explanted.
 
Event Description
Additional information was received stating that the patient¿s generator was replaced on (b)(6) 2014. The patient¿s lead was not replaced at this time. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results showed high lead impedance (dc dc ¿ 4). Subsequent normal and system diagnostics showed lead impedance within normal limits (dc dc ¿ 3). The patient reported that she noticed a change with her device. The patient was no longer able to perceive stimulation or voice alteration two days prior to the office visit on (b)(6) 2014. The patient also reported having hypoesthesia at her neck. No medication changes or programming changes occurred that could have caused or contributed to the hypoesthesia or decreased perception of stimulation. The patient reported no trauma related to the event. The neurologist stated that the patient¿s issues were due to battery depletion despite diagnostics showed eri = no. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. The notes indicate that the patient's device could not be interrogated during an office visit on (b)(6) 2013 so no diagnostic results were performed at that time. A battery life calculation using the available programming history showed approximately 3. 68 years until eri = yes. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3816311
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dennis100
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« Reply #1142 on: January 16, 2019, 02:42:55 AM »

Model Number 101
Event Date 03/01/2014
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic generator replacement. It was reported that preoperative and postoperative device diagnostics were within normal limits (dc dc code - 2). It was reported that the patient has not yet been seen for follow-up with the neurologist since the surgery. It was reported that the explanting facility discarded the explanted generator; therefore analysis cannot be performed.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
Additional information was received stating that the vns patient had a big aura on (b)(6) 2014. The patient became light-headed and was diaphoretic. The patient swiped her magnet but it did not help her aura. The patient stated that her previous auras were similar but not back up to pre-vns baseline levels. The patient did not have any auras after (b)(6) 2014. The patient also reported that her vns stimulation was no longer as strong as it was in the past. The patient¿s pre-operative evaluations had been completed. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the vns patient was experiencing an increase in seizures and pain/tightening at her lead site for the month prior to her office visit on (b)(6) 2014. The patient¿s device was not at end of service and had normal lead impedance (dc dc 2). The neurologist stated that the generator battery was probably low and was causing the patient¿s issues. Until recently, the patient was seizure free since vns. The patient also recently began experiencing daily auras. The patient had a bump on her neck that appeared a month before the office visit. The neurologist stated that the lead may no longer be tied down. The patient did not experience any pain when the lead site was touched but intermittently when vns stimulation occurred. X-rays were taken but have not been provided to the manufacturer for further evaluation. The patient was referred for generator replacement surgery. No known surgical interventions have occurred to date. Clinic notes were received indicating that the patient¿s device had not been interrogated for the past ten years. The patient reported having a tingling feeling at the generator site and can still feel stimulation that sometimes caused her to have voice hoarseness. As the patient¿s auras were becoming more frequent, the patient¿s settings were increased. Review of the available programming and diagnostic history showed the last known device settings were from 04/11/2003.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3804675
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dennis100
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« Reply #1143 on: January 18, 2019, 03:39:22 AM »

Model Number 106
Event Date 02/17/2016
Event Type  Injury   
Event Description
It was reported that it was known prior to implant surgery that the patient had severe cardiac issues before implant, but the patient was still implanted due to the vns benefits outweighing the risks. However, the physicians had a suspicion that the patient may have some issues after the surgery. When the case manager called the patient's girlfriend on (b)(6) 2016 to follow-up on the appointment, it was reported that the patient was still in the hospital due to clotting issues. The patient was hospitalized three days before the implant due to heparin bridging. The day after implant on (b)(6) 2016, the patient had surgery to drain the generator incision site. The neck site was also swollen and was noted that it would probably need draining also. She stated that it is not infection. It was indicated that this is not due to the vns, but because of the clotting issues that patient has due to the heparin bridging. The patient was seen on (b)(6) 2016, and the device was turned on. The patient tolerated activation well. The clotting issues had appeared to resolve, and the patient appeared to be fine. It was clarified that the fluid was in the neck, and was since absorbing after the procedure. The physician thought that the clotting was blood. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5505080
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dennis100
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« Reply #1144 on: January 19, 2019, 03:43:30 AM »

Model Number 303-20
Event Date 04/14/2014
Event Type  Injury   
Event Description
It was reported that the vns patient had an open wound at his neck incision site. Granulation tissue was observed eight months after implant and the open wound was first observed on (b)(6) 2014. The surgeon stated that there was no obvious reason for the granulation tissue. Debridement of the granulation tissue was performed. The surgeon stated that trauma possibly had caused or contributed to the event as the patient had seizures and hit the affected areas. No causal or contributor medication changes preceded the onset of the event. Further follow-up revealed that the patient was given antibiotics and the patient¿s issues resolved. The patient¿s issues came back and the surgeon stated that the device needed to be explanted due to abscesses at the lead site. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received stating that the vns patient developed another pustule at his neck incision site. The surgeon previously packed the wound and the granulation tissue appeared to resolve by (b)(6) 2014. However, granulation tissue was noted at the same site during an office visit on (b)(6) 2014. The surgeon speculated that an infection had developed or the patient¿s body was rejecting the device. Cultures showed moderate staph. The patient underwent surgery on (b)(6) 2014 to explant his generator and lead. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
On (b)(6) 2014 product analysis was completed on the explanted generator. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 995 volts (not at ifi), as measured during completion of the final electrical test. 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. Product analysis on the lead was completed on (b)(6) 2014. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3864292
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dennis100
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« Reply #1145 on: January 20, 2019, 03:16:57 AM »

Model Number 302-20
Event Date 08/25/2009
Event Type  Injury   
Event Description
It was reported that the patient underwent generator replacement. The lead was not replaced. Device diagnostics prior to and during surgery were within normal limits. It was reported that the explanting facility does not returned explanted devices for analysis.
 
Event Description
On (b)(6) 2015 the patient reported that his vns has been turned off for about 5. 5 months because of ¿several problems¿. It was later reported that the patient has had his device for a while due to painful stimulation. The patient will be proceeding with explant of the vns device. Although surgery is likely, it has not occurred to date.
 
Event Description
Initially, it was reported that the patient has experienced pain in the left jaw and teeth. The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth. The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging. The patient reported that there appears to be muscles twitching in his neck area. The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians. It was later reported that the patient would be referred to surgeon for full vns revision surgery. Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision. No additional relevant information has been received to date. No surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was turned up that day from 1. 0ma to 1. 25ma. Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again. It only lasted a little bit. The physician stated that the patient is having the same pain in the jaw with the new generator. The patient used to be set at 1. 75ma, but now when they turn the current up to 1. 25ma the patient experiences instant pain when the device turns on. He also states that after a few hours of normal operation the pain gets worse. Settings are output=1-1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin. Diagnostics are ok; impedance=2213ohms. The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.
 
Manufacturer Narrative
Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.
 
Event Description
Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014. The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option. During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down. Additionally, a tie-down had been placed on the electrode coil on the nerve. No other tie downs were observed. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845774
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« Reply #1146 on: January 21, 2019, 11:42:35 AM »

Model Number 302-20
Event Date 06/02/2014
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative

Event Description
During review of the available programming and diagnostic history, it was observed that the vns patient¿s device was disabled on (b)(6) 2004. Follow-up revealed that the patient underwent surgery on (b)(6) 2004 to explant her generator due to neck pain and lack of efficacy. The relationship between the neck pain and vns is unknown. The patient¿s neck pain was not related to stimulation and continued despite generator explant. The patient¿s lack of efficacy was attributed to the time needed to ramp up the patient¿s device settings to therapeutic levels. No patient manipulation or trauma was reported that may have caused or contributed to the patient¿s neck pain. The explanted generator has not been returned to date.
 
Event Description
On august 21, 2014 product analysis was completed on an explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator铠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 generator performed according to functional specifications; there were no anomalies found with the pulse generator. Product analysis on the lead was completed on august 26, 2014. Scanning electron microscopy image of the connector pin surface with opaque appearance shows that pitting or electro-etching conditions have occurred on the pin. Since portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3946880
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dennis100
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« Reply #1147 on: January 21, 2019, 11:43:56 AM »

Model Number 302-20
Event Date 04/25/2008
Event Type  Malfunction   
Event Description
Mfr received pa and lateral chest and left neck x-rays from the treating physician to review the integrity of the lead. The physicians notes regarding the x-rays stated that there was no lead breaks observed and the sys appeared intact. Review of x-rays by the mfr revealed no obvious lead discontinuities or anomalies. The lead pin was fully inserted in to the generator, but was not able to be visualized past the connector block. Further follow up with the treating physician revealed that the pt had surgery recently to remove cysts on the posterior neck region, and that the pt has lennox-gastaut syndrome, static encephalopathy, and medically intractable epilepsy. Additionally, it was noted at a recent follow up visit, a sys diagnostic test revealed high lead impedance. Attempts to obtain add'l info from the treating physician are underway. Revision surgery is likely.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Conclusions - 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=1059781
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dennis100
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« Reply #1148 on: January 22, 2019, 05:17:23 AM »

Model Number 304-20
Event Date 12/18/2014
Event Type  Injury   
Event Description
Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.
 
Event Description
Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.
 
Event Description
On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867152
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dennis100
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« Reply #1149 on: January 31, 2019, 02:35:02 AM »

Model Number MODEL 250
Event Date 09/22/2014
Event Type  Malfunction   
Manufacturer Narrative
Brand name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Type of device, name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Model #, serial #, lot #, expiration date, other, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, these fields are being updated to reflect the suspect medical device. Operator of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the user of the suspect medical device. If implanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. If explanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Device manufacture date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Labeled for single use, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Usage of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was seen in clinic on (b)(6) 2014 for a vns follow-up visit; system diagnostics were performed and the patient experienced pain at the electrode site with stimulation. No changes were made to the patient¿s device settings during the office visit. The patient reported that when he swipes his magnet, he feels the same pain. The patient returned to the clinic on (b)(6) 2014 and the device magnet current different than what was previously programmed. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4207463
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« Reply #1150 on: February 05, 2019, 03:17:40 AM »

Model Number 302-20
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high impedance (impedance value = 10,000 ohms). A few months prior to the observed high impedance condition, the patient was experiencing shocking sensations at his neck which had recently resolved. No known surgical interventions have occurred to date. X-rays were taken and were reported by the physician to be unremarkable. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2015 to explant his device. The patient¿s family elected not to replace the system as the patient had been seizure-free for over a year. The explanting facility misplaced the explanted devices and was unable to return the devices to the manufacturer; therefore, no analysis can be performed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. 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=4348113
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« Reply #1151 on: February 07, 2019, 09:15:46 PM »

Model Number 302-30
Event Date 12/18/2014
Event Type  Malfunction   
Event Description
Analysis of the returned lead portion was completed which confirmed opening of the inner tubing, exposing conductive quadfilar coils. The openings may have been wear-related and may have contributed to the reported muscle spasms. Scanning electron microscopy images of the connector ring surface show that pitting or electro¿etching conditions have occurred on the surface. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Note that since the lead¿s electrodes were not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not observe any lead discontinuity. Lead discontinuity is suspected in the lead portion not returned, but did not cause or contribute to a death. Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the fluid leaks found during product analysis.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (impedance value ¿ 8180 ohms). The patient presented with an increase in seizure frequency and experienced neck twitching during device programming at the visit. The patient¿s device was disabled and the patient was sent for x-rays. The patient underwent lead replacement surgery on (b)(6) 2014. The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits (impedance value ¿ 1323 ohms). The explanted lead has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4426437
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« Reply #1152 on: February 09, 2019, 03:27:32 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/17/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was hospitalized due to difficulty swallowing. The patient has since been discharged and is doing better. The physician believed that the difficulty swallowing was most likely the result of anesthesia and intubation during vns surgery. Clinic notes were received dated 12/31/2018. After the patient¿s generator was replaced, the patient was admitted to the hospital due to vomiting and gagging and remained hospitalized for 11 days. The patient had an increase in seizures and severe constipation as well. Per the physician's assessment, the patient had a similar response to t&a so it is unknown if this was due to anesthesia or due to swelling in the neck following surgery. Attempts were made to the physician for more information. Per the physician, the patient's increase in seizures was believed to be due to missing medications due to vomiting. The increase in seizures was above pre vns baseline. The cause of the vomiting was unknown if it was due to constipation/discomfort from vns surgery/presumed neck swelling. The anesthesia and medications may have also contributed. The vomiting started the day after vns surgery. The patient had improved as quickly as it began. The constipation was a chronic condition that was made worse by surgery, likely due to anesthesia and was unrelated to the vns. The patient's swelling was only presumed based on symptoms. The swelling of the neck was from the vns surgery and began on the day of the vns surgery. The device history records were reviewed for the generator and lead. They passed all specifications prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8272311
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« Reply #1153 on: February 09, 2019, 03:28:15 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient believed she experienced issues with her vagus nerve that caused stomach pain, pain in her neck that radiates down to the chest, migraines, and black out spells. The company representative indicated that the patient's generator system diagnostics were within normal limits. No known 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=8224067
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« Reply #1154 on: February 09, 2019, 03:28:57 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/01/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported via clinic notes received by the manufacturer that following the generator replacement several years prior, the patient experienced significant side effects and significant pain in his neck. A fractured wire was found and ¿after repair,¿ the patient had experienced improvement in his discomfort. The implant card from the surgery indicated that the impedance at the time of the surgery completion was "ok. " no impedance value was provided. The reason for the vns generator replacement was battery depletion. It was unclear if the lead was repaired using non-manufacturer products or if the lead was replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8245610
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« Reply #1155 on: February 09, 2019, 03:29:45 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2018
Event Type  Injury   
Event Description
The patient reported that they are having inflammation and are unable to turn their neck. The patient¿s neurologist was looking for a surgeon in order to have their device explanted. Clinic notes were received for the patient¿s explant surgery. Per the clinic notes, the patient has neck pain that she believes is due to the lead pulling on their nerve. The pain occurs intermittently and mild head turns can set off severe pain in her neck and in the muscles, and she limits her neck motion and arm motion to avoid pain. The patient¿s device was disabled for about two years. Programming history was reviewed for the generator. The generator normal mode was disabled on (b)(6) 2013, however magnet mode was left on. The patient¿s generator was completely disabled on (b)(6) 2015. No programming anomalies were seen. Information was received from the physician's assistant. It was unknown when the patient¿s pain began, and the patient had x-rays taken that appeared normal. The physician¿s assessment on the pain was unknown. The patient¿s device was disabled prior to her coming to their clinic, and the reason for disablement was unknown. Surgery is likely but has not 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=8272345
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dennis100
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« Reply #1156 on: February 12, 2019, 03:21:16 AM »

Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient presented with new symptoms during an office (b)(6) 2015. The right side of the patient¿s lower face and upper neck was twitching which would occur for a few minutes and then stop. The patient also was having sharp pains on the left side of her head that occurred daily. High impedance was observed during the office visit and the patient¿s device was not disabled.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). The patient¿s device showed lead impedance within normal limits (dcdc ¿ 2) at the previous office visit on (b)(6) 2014 the patient was referred for surgery but no known surgical interventions have occurred 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=4532847
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dennis100
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« Reply #1157 on: February 13, 2019, 03:00:32 AM »

Model Number 304-20
Event Date 01/03/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that the patient is undergoing ent procedures to treat painful stimulation in the neck and head, voice alteration, and coughing that he has been experiencing since early january. However, the device being disabled has also helped diminish these symptoms as they were thought to be related to stimulation during high impedance. No known vns surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient underwent a recent brain surgery and the vns is still disabled. The patient's previous neurologist has no additional information to provide. No known surgical interventions have occurred to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (6592 ohms). Previous device diagnostics on (b)(6) 2015 were within normal limits (2736 ohms). X-rays were taken and did not identify any obvious discontinuities with the vns system. The generator was programmed off and the patient was referred to surgeon. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4516986
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dennis100
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« Reply #1158 on: February 14, 2019, 02:19:19 AM »

Model Number 304-30
Event Date 11/23/2014
Event Type  Malfunction   
Event Description
Additional information was received that the patient is still experiencing ¿pulling¿ sensation and discomfort in his left neck area. The device is currently off.
 
Event Description
It was reported that, for the past 1. 5 months, the patient has had random episodes of sudden discomfort from the generator site up to the left side of his neck that is progressively worsening and occurs 5 times per day. The nurse practitioner has adjusted vns but the discomfort doesn't seem to reduce and might not be associated with the stimulation. The patient experiences discomfort when he is lying still, sitting, or standing, doesn't seem to have any trigger. Patient was contacted several times to visit the clinic to adjust vns or disable vns if needed. But patient has not been able to visit due to transportation issues. Patient was last seen in (b)(6) 2014 and patient was set to comfortable settings at that time. No issues were reported with the device during this visit. Patient has been provided with medications for the pain meanwhile. X-rays were received with a note stating that the patient has been complaining of severe neck pain that radiates into his left clavicle. The pain was reported to be independent of vns activation and he does have pain when he turns his head. Per the nurse practitioner, there is a possible mircrofracture of the lead and the vns was disabled. The patient¿s next appointment is on (b)(6) 2015. The x-rays were reviewed and there did not appear to be any lead discontinuities in the portion of the lead that could be visualized. It was noted that the strain relief bend did not appear to be present. The lack of strain relief bend could possibly be a factor in the patient¿s pain. However no conclusions can be drawn regarding the exact cause of the pain. Attempts made for the diagnostic test results were unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received that the patient's device diagnostics were checked on (b)(6) 2015 and that the results were within normal limits. It was also reported that the patient's pain was slightly better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4639353
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dennis100
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« Reply #1159 on: February 15, 2019, 03:51:54 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/29/2017
Event Type  Injury   
Event Description
It was reported that this patient presented with a sore throat and increased mucus production when visiting the ent regarding their vocal cord paralysis and leukoplakia.
 
Event Description
It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Event description, corrected data: the initial report inadvertently did not state the patient's sore throat and increased mucus production. Patient problem codes, corrected data: the initial report inadvertently did not include pain and discharge as patient problem codes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7230517
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dennis100
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« Reply #1160 on: February 16, 2019, 03:03:05 AM »

Model Number 302-30
Event Date 07/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic note dated (b)(6) 2015 note that the patient was undergoing surgery due neck pain at the left side of the neck. Surgical notes indicate that the surgery was unremarkable. It was reported that the patient did not have another vns system placed because the patient was "epilepsy free". The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Clinic notes were received dated (b)(6) 2015 that indicated that a patient implanted with a vns device has been experiencing pain at one of their lead "anchor" sites since he was last seen in (b)(6) 2014. The pain has persisted, the patient takes advil but is still able to complete daily activities. The patient was referred for surgery for "removal of the anchor. " additional information was received that reported they were having their vns removed although unclear if whole device or just the anchor. Their pain is reported to be located in their neck and caused by a disconnected lead. It is unknown whether their was any trauma that caused the event.
 
Event Description
Analysis of the returned generator and lead was completed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4588059
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dennis100
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« Reply #1161 on: February 16, 2019, 03:04:32 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620110
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