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dennis100
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« on: September 06, 2017, 08:41:38 AM »

Model Number 102
Event Date 08/06/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing spasms of the sternocleidomastoid muscle with device stimulation which was causing the patient to experience head deviations which resulted in airway obstruction. It was reported that the patient used the magnet to disable the device and that the spasms resolved for about 10 minutes, but then started back up. It was reported that it is unclear if the magnet moved off the device because the physician was not present at this time. The patient was seen by the physician at the hospital and the device was programmed off. The physician indicated that it was unclear whether or not the patient's accessory nerve was being stimulated to cause this or whether there is current leakage to the muscle. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3329805
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dennis100
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« Reply #1 on: September 06, 2017, 08:42:31 AM »

Model Number 103
Event Date 10/19/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Initially, it was reported that the patient developed a new seizure since generator replacement that was head bobbing. Clinic notes dated (b)(6) 2014 were received indicating that the patient's father would like the vns removed because he feels that the patient's head bobbing was related to vns. It was noted that the vns remains off and no head bobbing episodes have been seen. The patient was referred for surgery. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4226801
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dennis100
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« Reply #2 on: September 06, 2017, 08:43:18 AM »

Model Number 102
Event Date 01/23/2013
Event Type  Injury   
Event Description
Additional information was received which indicated that the patient is taking six different medications which is making him sleep a lot and made him lose a lot of weight. It also indicated that the patient's seizures have decreased after the vns battery depleted and the parent prefers not to revise the vns. Additional information revealed that the patient was cleared for surgery and the surgery date was scheduled on (b)(6) 2013. On (b)(6) 2013, the patient's vns generator was replaced. The explanted generator will not be return as the site does not return explanted products.
 
Manufacturer Narrative

Event Description
It was reported by the patient's mother that the patient would jerk his head and that his seizure patterns have changed while the vns battery was reportedly depleted. The programming history database was reviewed and it was noted that the physician had the patient set on a 57% duty cycle from date (b)(6) 2011 which is considered as excessive. The physician was contacted, but did not respond to date. Surgery to replace the vns generator is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2974018
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dennis100
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« Reply #3 on: September 06, 2017, 08:44:01 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 10/13/2013
Event Type  Injury   
Event Description
Clinic notes were received for reimbursement purposes on (b)(6) 2015. Notes dated (b)(6) 2015 indicate that the patient's generator is 10 years old and that it is nearing end of life. Patient was also reported to be having seizures and was referred for generator replacement. Notes dated (b)(6) 2015 from the generator replacement surgery indicates that the patient had increased seizures.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2014 noted that the patient has had increasing episodes where she feels like she is going limp, her head goes ack and her eyes roll back. It was noted that the patient is sleepy the remainder of the day and that this has been occurring for approximately 4-5 months. The device was interrogated and ifi was no. The device output current was increased from 1. 75ma to 2ma. The patient was referred for surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent prophylactic generator replacement on (b)(6) 2015. The explanted generator was reported to be discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4329443
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dennis100
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« Reply #4 on: September 06, 2017, 08:44:39 AM »

Model Number 103
Event Date 10/03/2013
Event Type  Injury   
Event Description
Additional info received on 2/26/2014: our son was riding in the car watching a movie and his head jerked downward and back up three times. This happened very quickly and lasted just a few seconds. He is tired and holds his head after. He had these start happening immediately following the replacement of the vns generator on (b)(6) 2013. There were several other episodes but i did not log them all down. The vns settings were adjusted by his neurologist and we didn't see any events for several days. Then on (b)(6) 2014 we saw it happen again while riding in the car. These events were reported to his neurologist dr. (b)(6) and she called cyberonics on three occasions. They have not responded to our issue with this generator. I happened to see two of cyberonics sales rep at an informal epilepsy meeting in (b)(6), and i did tell them about it, and they stated they knew dr. (b)(6) had called and that they were supposed to call us but had not at that time. It had been a week and we received no call. About a week or two later we were in dr. (b)(6)'s office and she asked if anyone had called us and we told her no. She made one or two other phone calls to cyberonics and explained what was happening and they have failed to follow up with us on this problem. We have just seen this one episode since the last vns adjustment, but we feel they may just be happening less often and nor always visualized.
 
Event Description
Vagus nerve stimulator generator was replaced and re-implanted on (b)(6) 2013. That evening he experienced his first uncontrolled head movement. It appears to jerk forward and down then back very quickly. We saw this happen on (b)(6). There were probably other dates it happened, but these are the ones that were witnessed. On (b)(6) he had a 24 hr eeg during which he had several of these movements. On each date these movements happened multiple times and was causing great discomfort to our son. Each time this happened he was left tired and would say his head hurt. Our son is mentally disabled and is not able to fully explain his experience. On 3 occasions he was holding an ipad, or iphone and we thought it was related to that, but following episodes he was not holding anything. The vns settings were set in surgery. Since the surgery, he has had to endure a 24 hour eeg to rule these out as seizures. It was determined that they are not seizures therefore we believe they are indeed the device causing this. The neurologist has adjusted the vns twice and after the second time we haven't seen any yet.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3599446
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dennis100
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« Reply #5 on: September 06, 2017, 08:45:21 AM »

Model Number 103
Event Date 12/13/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2012, when analysis of the returned generator was completed. The generator was found to be functioning as intended and the ifi (intensified follow-up indicator) was sent to yes. The data stored in the generator revealed that 84. 075% of the battery had been consumed and the voltage was 2. 791 suggesting a partially depleted battery however the generator could deliver the programmed settings.
 
Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2011 due to a prolonged partial seizure that consisted of quick jerking of her head to the left. When the patient was in the er, these movements were not identified as seizures and they continued for over an hour after being given 20 mg of valium. The device was interrogated and found to be programmed to 1. 75/30/250/30/1. 8/2/250/60 and 1/3 of the battery was left. The output current was increased to 2 ma and the magnet output current to 2. 25 ma. The physician was also going to increase the dosage of rufinamide and see about different dosing strategies for the vns. Clinic notes dated (b)(6) 2011 stated the seizure frequency increased. In clinic notes dated (b)(6) 2011 stated that the patient had 6 seizures in 1 week which was unusual, however, it was being attributed to the dosage of lamictal. The patient began to experience another increase in seizure activity at the end of (b)(6) 2012 and the patient would be referred for generator replacement surgery. Good faith attempts to obtain additional information were unsuccessful.
 
Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient had the generator explanted and replaced prophylactically. The explanted generator has been returned to the manufacturer and is currently in product analysis. Device evaluation has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2498678
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dennis100
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« Reply #6 on: September 06, 2017, 08:46:07 AM »

Model Number 103
Event Date 01/06/2012
Event Type  Injury   
Event Description
On (b)(6), 2012 additional information was received when the patient further stated that while she was still implanted, she visited the emergency room twice because of burn marks received when using her magnet. The patient stated that both emergency room physicians advised her that she needed the device explanted before she died from it. However clinic notes from the patient's visit from the neurologist on (b)(6), 2012 were obtained which stated the vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The patient said she can't wear her hair down because when it touches her neck she has severe pain. The patient additionally stated that she had traumatic brain injury (tbi) before being implanted and therefore should not have been implanted in the first place.
 
Event Description
On (b)(6) 2012 the vns patient reported that since (b)(6) 2011 she has been experiencing pain in her head that is different from a headache, as well as pain in her right arm and an increase in seizures. The patient stated that the pain usually occurs after she has had a seizure. The patient did not know the relation of her increase in seizures to pre-vns baseline levels. The patient reported to the case manager that she is not currently seeing a neurologist as she has a different insurance now. The patient sated that she is feeling a constant low voltage electrical shock in her brain. The patient taped her magnet over the device and said she experienced a burning feeling from the magnet. She said there was a burn mark on her skin when she removed the magnet. She stated that when the magnet was taped over the device, she did not feel the painful stimulation. The manufacturer's consultant reported that the patient had previously lied about her insurance so finding a neurologist was difficult. They found one the patient could see but the patient's husband refused to drive her there. The patient then showed up at the emergency room where the patient's real insurance information was discovered. The patient was seen by a neurologist and he disabled her device because of her reported pain. He went ahead and referred her to a surgeon because of the pain but she screamed at the neurologist and the staff so he asked her to leave and he will not see her again. The patient stated that she still felt painful stimulation even when the device was off and that the magnet stimulation burned her when she swiped the magnet. The clinic notes from the patient's visit from the neurologist on (b)(6) 2012 were obtained which stated that the patient was tearful and hysterical over the pain due to vns. The patient was angry that vns has not helped her. The pain and burning was reported to have started on (b)(6) 2012. The patient stated that she is currently taking hydrocodone for the pain but asked for more pain medication. The neurologist tried to run diagnostics but the patient would not tolerate it and remained hysterical and belligerent. The vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The manufacturer's consultant reported that the patient had her generator and lead explanted on (b)(6) 2012 due to a device malfunction. The patient's husband did not want the explanted product sent to the manufacturer for product analysis; however the surgeon did want the devices sent to the manufacturer. The husband became verbally abusive and was provided the options of having the manufacturer perform product analysis on the device or have the device sent to him without product analysis if he signed a release form.
 
Event Description
Additional information was received on january 26, 2012 when the explanted lead and generator were returned to the manufacturer for product analysis. The electrode array portion of the lead was not returned for analysis, and therefore, an evaluation and resulting commentary cannot be made on that portion of the lead. Visual examination of the lead identified what appears to be a cut opening and a puncture in the outer silicone tubing. No obvious damage to the inner silicone tubing of the lead coils was noted at these locations. The conditions are consistent with those observed due to the explant process. The lead assembly has remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. The assessment of the believed leakage path was the cuts or punctures made in the lead during the explant procedure. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis on the generator was completed on february 9, 2012. Electrical test results demonstrate that the pulse generator performs according to functional specifications and there are no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434478
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dennis100
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« Reply #7 on: September 06, 2017, 08:46:47 AM »

Model Number 102R
Event Date 04/20/2015
Event Type  Injury   
Event Description
It was reported that the patient has begun experiencing head drops. The patient reported that the feeling is similar to when she had a seizure, but that she had never experienced that symptom before. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4778950
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dennis100
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« Reply #8 on: September 08, 2017, 10:21:19 AM »

Model Number 300-30
Event Date 12/01/2010
Event Type Malfunction
Manufacturer Narrative
Corrected data: new information received indicates that the lead was not explanted.

Event Description
It was reported by a nurse that a vns patient reported buzzing and pain in the top of his head that had occurred 3 times within the last 3 weeks of initial report. The patient reported that placing the magnet on the generator ameliorated the pain. Moreover, the patient indicated the pain was not occurring with normal stimulation and no patient manipulation or trauma was reported. The nurse further stated that a generator diagnostic tests was performed and received a low impedance warning. The patient was interrogated and the device was found to be at 0 ma. The patient was re-programmed to 1. 5/25/500/30/1. 1 then performed system diagnostics which resulted within normal limits (ok/ok/1/no). Further information from the treating nurse indicated that the patient was scheduled for complete replacement. Moreover information from a company representative indicated the patient underwent surgery as scheduled. Good faith attempts to obtain the explanted devices have been unsuccessful to date. Additional information was received from the treating neurologist indicating the cause of the buzzing was related to generator with/ or wire malfunction. Moreover, the replacement surgery was done for patient comfort according to the neurologist.

Event Description
Further follow-up revealed that during the surgery a dual pin generator was not available. It was reported that the patient was closed and a dual pin generator was located and the patient was taken back to the operating room the same day for only generator replacement. The lead was not replaced as previously reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1989992&pc=LYJ
« Last Edit: February 03, 2018, 03:03:39 AM by dennis100 » Logged
dennis100
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« Reply #9 on: September 16, 2017, 12:56:10 AM »

Model Number 103
Event Date 01/27/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.
 
Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.
 
Event Description
Clinic notes were received on (b)(6) 2012 from, a physician's office. The notes covered the patient's physician visit from (b)(6) 2011 to (b)(6) 2012. The patient was implanted on (b)(6) 2011, at which time the device was not programmed on. On (b)(6) 2011, notes reported pain at the surgical site, hoarse voice, and "multiple grand mal seizures after vns. " the vns incision lines looked good, were both healing well, without tenderness. The neck incision had surrounding swelling. On (b)(6) 2012, notes state that the patient's hoarse voice was gone, there was no more pain at the vns site, and no change in frequency. The notes indicate that the patient's device was turned on, and the patient did not feel anything. No settings are provided for this date, and initial interrogation at the next appointment indicates normal mode and magnet output currents were 0 ma. On (b)(6) 2012, the patient reported an increase in seizures and duration, along with aggression. The notes report that the magnet did seem to stop the seizures and make them shorter; however, settings from this date indicate that the device was programmed off until this appointment. The patient experienced painful magnet mode stimulation for the first magnet activation. On (b)(6) 2012, it was stated that the patient felt he had an upper respiratory infection the previous week. The patient turned during sleep and "felt spinal cord electricity," a lack of consciousness for 30 minutes, and then numbness throughout his head, which continued. There was now a change in seizures: the patient had a warning and then an out of body experience. He was unable to use the magnet during this time. The patient's aggression was reported to be less, he did not have any more headaches, but he did have neck pain. On (b)(6) 2012, notes reported that the seizures did decreased but have recently reoccurred. The patient occasionally coughed with vns but had no serious ill effects. The patient did experience coughing and choking during magnet stimulation; however, the magnet did abort seizures well. The patient's vns was adjusted, and the physician ensured that the patient tolerated both normal mode and magnet stimulation. On (b)(6) 2012, the patient was seen for increased blood pressure and a check of the patient's vns after the patient held a shocking dog collar while the collar was charging. The patient's vns settings were altered. This event is captured in mfr. Report # 1644487-2012-01066. On (b)(6) 2012, notes report that the patient was having the same amount of seizures (4/day) and no issues since turning the stimulator back on from the collar incident. On this date, the patient's settings were adjusted. On (b)(6) 2012, the patient was seen again for marked aggression, agitation, and an increase in grand mal seizures since the adjusted settings the previous day. The magnet did not seem to stop the seizures. The patient's mother taped the magnet over the patient's vns to disable the device, and all symptoms stopped. The patient's settings were reduced to (b)(6) 2012 settings. On (b)(6) 2012, the patient was reported to have a bad mood, irritable, snapping, and having more seizures. He was saying things he wouldn't have in the past and demonstrating almost manic-depressive type behavior. The patient became violent, hit his parents, screamed, held his head, demonstrated symptoms like a grand mal seizure, and later bit his finger. The patient was not able to perceive normal mode or magnet stimulation. The patient's mother felt that things were going well with vns at first, but felt as though the seizures were never really controlled. The patient's normal mode output current was programmed off, and the magnet was programmed to a higher output current that resulted in a cough lasting less than 5 seconds. Follow up with the nurse practitioner revealed the following information: the patient's increase in seizures was below his pre-vns baseline. The patient was treated by his primary care physician for the upper respiratory infection; however, the nurse practitioner did not think that the infection was related to vns. When asked about the change in seizure reported on (b)(6) 2012, no additional information regarding the change in seizures was available; however, the change was attributed to anxiety. The patient's anxiety was caused by vns: the presence of the device and the surgery. The nurse practitioner believes that the vns causes the patient anxiety. The anxiety, in turn, propagates more seizures. The patient was placed on medication to assist with the anxiety and sleep. There are discrepancies between the settings from appointment-to-appointment that may be due to recording errors. Attempts to obtain the physician's flashcard to review the patient's complete programming history are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000
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dennis100
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« Reply #10 on: September 21, 2017, 12:47:39 AM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.
 
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613
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dennis100
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« Reply #11 on: September 22, 2017, 01:12:52 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
The patient's explanted generator and lead were retuned on (b)(6) 2012. A 'return product form' indicated that the device were explanted due to prophylactic replacement and because the patient did not feel magnet mode stimulation consistently, along with increasing symptoms. Evaluation of the explanted pulse generator's reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Follow-up on (b)(6) 2012, showed that the lead was explanted due to a lead discontinuity. Diagnostics from (b)(6) 2012, were also provided. This lead event, along with product analysis results for the explanted lead, is captured in mfr. Report #1644487-2012-02507. Additional follow-up with the initial reporter showed that the patient's events had not resolved since revision. The patient still had the feeling that she was going to have a seizure daily; however, the patient would also feel anxious during these events, so it was difficult to say what the patient was actually experiencing. The patient could also not feel magnet mode stimulation. This was attributed to the patient's current settings being lower than pre-revision settings. The patient was slowly being ramped up. The patient's pre-operative settings and settings from her most recent appointment ((b)(6) 2012) were provided.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient could not feel magnet mode stimulation. The patient did report an inability to perceive normal mode stimulation. The nurse also reported that the patient complained of feeling "seizurey. " this was clarified to mean an increase in seizures. The patient's diagnostics were provided (date unknown). The patient's settings from (b)(6) 2011, (b)(6) 2012, and earlier were provided. A battery life calculation was performed on (b)(6) 2012, with 1. 6 years remaining until eri = yes. On (b)(6) 2012, the patient's nurse provided the following information. The increase in seizures was first observed in (b)(6) 2012. The patient was brought into the hospital for a possible seizure, associated with volume depletion/dehydration. The patient's constant feeling of being "seizurey" started within the past month. The nurse stated that it is unclear if these are prodromal symptoms and/or partial seizures. The symptoms consist of room spinning, numbness left side of head, confusion, and being scared. The patient has a history of mesial temporal sclerosis by mri and generalized activity on eeg. The nurse was unable to get an accurate count of the events. The nurse stated that while diagnostic testing is within normal limits, she presumed that the change in stimulation sensation and increased events are likely related to battery reaching end of service. As intervention, the patient's pulsewidth was decreased on (b)(6) 2012, and the patient's keppra dose was increased on (b)(6) 2012. Prophylactic replacement of generator was also being planned. No information was provided regarding the comparison to pre-vns seizure levels. In response to causal/contributory programming changes or events occurring prior to the increase in seizures, the nurse stated that the patient was admitted to the hospital in (b)(6) 2012, for dizziness followed by loss of consciousness. There was no clear cause, but the patient was hyponatremic, had a subsequent confusion episode and a possible seizure associated with dehydration. Within past month, there have been other possible lifestyle triggers but these were not new. The failure to perceive magnet mode stimulation was first observed within the past month. The patient reportedly uses the magnet frequently and reports being unable to feel magnet stimulation in past month. Previously, she had been able to feel it. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient's magnet mode diagnostics were not run. On (b)(6) 2012, the patient underwent surgery. Attempts for product return have been unsuccessful. An additional battery life calculation was performed on (b)(6) 2012, with updated data. The results indicated 1. 69 years to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702307
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dennis100
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« Reply #12 on: September 23, 2017, 03:32:27 AM »

Model Number 103
Event Date 06/03/2012
Event Type  Malfunction   
Event Description
A vns consultant was at a patient's clinic visit and it was noted that the patient had high lead impedance. : lead impedance high, output current = low, and impedance value = over 10000ohms. There was no trauma reported. The patient could not feel the stimulation, even after they tried to increase the settings. The patient usually had a noticable change in voice with stimulation, but that was no longer noticable. It was reported that a week ago the patient had turned her head to the right, and had felt like the stimulation was stronger. This was the only occurrence of "stronger stimulation". The patient went to surgery. Their impedance was high when a system diagnostic test was done before surgery. The connector pin was not inserted all the way. The connector pin was taken out and put back in and their high impedance resolved. After the pin was re inserted three system diagnostics tests where run with all ok.
 
Event Description
Programming history was received for review and a change in impedance was noted on (b)(6) 2012 to over 10,000 ohms. Their generator was disabled on 7/19 prior to surgery. No patient fall was reported prior to their high impedance being attained. X-rays were not sent to the manufacturer for review.
 
Manufacturer Narrative
The connector pin was not fully inserted into the header of the generator confirmed in surgery.
 
Manufacturer Narrative
Date of event corrected data: updated to reflect actual date of event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2685054
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dennis100
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« Reply #13 on: October 04, 2017, 12:51:17 AM »

Model Number 102
Event Date 09/11/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013, this vns patient¿s caregiver poste a comment on social media. The caregiver reported that the patient has a vns. The system developed a fault: a fractured wire. Through ignorance of the patient¿s caregiver, the event gave the patient a very bad time for four months. Replacement took place, but the event stepped back the patient¿s progress.
 
Event Description
A vns treating physician reported to our country representative from (b)(6) they had a vns patient who was experiencing discomfort with stimulation, coughing with interrogation/programming, possible hoarseness and had his generator disabled. Since (b)(6) 2012, the date the patient had dental procedures and ct brain/facial bones, the patient has experienced the discomfort, making noises and coughing. Information received reported that the patient has experienced recent onset of +++ discomfort , making noises at regular intervals and holding his left side of his face/ head again at regular intervals. The patient in the last 3 - 4 weeks was making noticeable abnormal noises (possibly hoarseness) every 3 mins and also holding his hand to the left side of his head again at definite intervals. The patient is moderately to severely intellectually challenged and this intolerance is not uncommon behaviour. His father also reported that this was noticeable all night long when he picked him up and travelled with him to his neurology appointment. On (b)(6) 2012, vns was interrogated and settings were: 2. 0 ma, 30 hz, 500 pw, ot 30 secs, off t 3. 0, mag 2. 25ma, ot 30 secs, diagnostics system diagnostic test dcdc 2, normal mode diagnostic test 3, telemetry ok, lead ok. On interrogation the patient coughed profusely lasting > 60 secs. At previous visits this behaviour has not been seen. At the clinic session - their output current was lowered down to. 5ma steps to 0. 25ma. With the same outcome - +++ coughing, facial flushing and hand holding left side of head for >60 secs. They also attempted to reduce hz to 20 hz at. 25ma and same results. On turning their device off all symptoms subsided. Since their vns was programmed off the patient experienced an increase in the severity of their seizures with the loss of therapy. Since the patient does not live with the person who reported their seizures their md is not sure the information is reliable. X-rays were received for review. The electrodes are visualized but it is not possible to ascertain the placement in relationship to the cervical vertebrae due to limited views. A strain relief bend and loop are present but are difficult to assess due to the film angle. The loop appears to be in a "head-on" view. Two tie downs are noted securing the lead. It is noted the strain relief bend is not secured lateral to the anchor tether. A strain relief bend was present but there was no tie down present securing the bend, there was what appeared to be a loop with one tie down. A full loop cannot be confirmed based on the angle of the pictures. Another tie down was noted near the header of the generator therefore not placed per labeling. The strain relief should be adequate to allow for full neck movement to its maximum stretched positions. Most of the lead was visible and no obvious lead discontinuities were identified. Some lead is behind the generator and this portion cannot be assessed. The lead was intact at the connector pin but based on the angle of the generator header it could not be determined if the lead pin was fully inserted or not. The filter feedthroughs appeared intact. The patient had full revision surgery and it was noted on (b)(6) 2013 that they had a lead break in the potion that was apparently covered in the x-rays by the generator. Their explanted lead has been returned for analysis and is pending completion.
 
Manufacturer Narrative
X-rays were reviewed and were not able to access the header of the generator. Pin not being fully inserted was confirmed in product analysis. Findings.
 
Event Description
Product analysis was completed on the patient's explanted generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Lead analysis was completed. The lead was returned in five pieces. Two large and several small pieces. A lead break was not observed during this analysis. One set of setscrew marks was found near the end of the connector pin. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. 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. The incision, puncture and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the 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 pulse generator at one time. 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 a lead discontinuity. When the patient's device was programmed off they had an increase in frequency and in severity of their seizures but still the same type of seizure. The patient was injuring himself during his seizures.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device malfunction 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=2976596
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« Reply #14 on: October 06, 2017, 02:08:13 AM »

Model Number 103
Event Date 09/27/2011
Event Type Injury
Event Description
A vns patient reported to the manufacturer on (b)(6) 2011 that she was experiencing pain "all over" and sometimes in her head and neck. The patient was attributing the pain to vns. The patient did go to the emergency room and was treated with anti-inflammatory medication. The patient is under a great deal of personal stress. The patient was advised to follow up with her physicians, but the physicians would not see the patient. The patient later reported to the manufacturer on (b)(6) 2011 that she was attributing her pain to a fall or her medications or possibly an ulcer. The patient is to follow up with a nurse practitioner in (b)(6) 2011. Attempts to the nurse practitioner for further information are pending.

Event Description
The patient reported that she is ok, but that she no longer has transportation to her physician and is searching for a new physician. No additional relevant information has been obtained to date.

Event Description
Vns generator product information was obtained from the implanting hospital.

Event Description
The patient reported that her settings were lowered by half and the next day she was experiencing pain. She went to the emergency room the day prior and was sent home. The patient noted that her whole body is sore and that she walked a lot yesterday.

Manufacturer Narrative

Event Description
Reporter indicated there "is nothing wrong with my vns" and that the issue of pain was felt to be related to medication and not vns. The vns is felt to be "working well" per the reporter, but she has no physician to check the vns. All attempts to obtain vns generator product information from the implanting hospital have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2309512
« Last Edit: February 13, 2018, 01:40:11 AM by dennis100 » Logged
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« Reply #15 on: November 01, 2017, 01:25:36 AM »

Model Number 105
Event Date 05/12/2014
Event Type Malfunction
Event Description
It was reported by the patient that her device settings had changed on their own from 5 to 10. It is unclear which device settings she was referring to. The patient was experiencing erratic stimulation, pain with stimulation, coughing and voice alteration. The pain was reported to be unbearable at times. The pain occurred at her electrode site and travelled up the left side of her head and down to her shoulder. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854286
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« Reply #16 on: November 15, 2017, 02:40:02 AM »

Model Number 103
Event Date 10/25/2010
Event Type Injury
Event Description
It was later reported that the patient had generator explant on (b)(6) 2015 due to pain and not having epileptic seizures. Vns was originally implanted for seizures and then she later learned she had pseudo seizures. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date.

Event Description
Although explant surgery is likely, it has not occurred to date.
Manufacturer Narrative

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect data. Date of event, corrected data: the initial report inadvertently reported the incorrect data.

Event Description
It was identified that the pin portion of lead was discovered in the generator header. Analysis has not been completed to date.

Event Description
It was reported that the patient was scheduled for a vns removal surgery. It was originally implanted for seizures and then she later learned she had pseudo seizures. The device was off for some time and she still had chest wall pain and when on stated her head was twitching. It was noted that the patient could not even tolerate mild stimulation. The physician reported that no causal or contributory programming or medication changes precede the onset of the head twitching and pain. He stated that he did not know if interventions were taken. He also stated that he didn¿t know the relationship of the head twitching and pain to vns. No manipulation or trauma occurred that is believed to have caused/contributed to the chest pain. He was also unable to provide the date of disablement. The patient¿s programming history was reviewed and the patient was disabled on (b)(6) 2010. Diagnostics were normal on that date as well.

Manufacturer Narrative
Device available for evaluation, corrected data: the supplemental report #2 inadvertently did not report this data in this field.

Manufacturer Narrative
Analysis of programming history.

Event Description
Lead product analysis was approved on 05/27/2015. The lead assembly (body) including the section of the connector boot containing the model and serial number tag and the electrode section was not returned; therefore, it was not possible to verify the model and serial number during this analysis, and 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. Generator product analysis was approved on 06/03/2015. In the (b)(4) lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery (2. 963 volts as measured during completion of electrical testing) shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4609356
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« Reply #17 on: December 09, 2017, 02:09:21 AM »

Model Number 102
Event Date 05/10/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received which provide the patient's seizure history. It was stated that the patient is still having seizures daily. The patient's last seizure was a grand mal seizure that lasted 2 minutes that day, and prior to this was the same type and length of seizure on (b)(6) 2013. The patient has continued with nocturnal events semiology of complex partial seizures per his baseline. He began having daily episode of quick head drops about one week prior to this date. His mother noted drainage from his left ear and had scheduled a follow up appointment to the ear nose throat doctor. It was noted that prior ear infections have been a trigger for the patient's epilepsy and mcad related hypoglycemia. Following a neuro metabolic consult, genetic testing confirmed the patient had mcad. Following the introduction of banzel, the patient became seizure free with associated improved cognition and psychomotor activation. Drop seizures returned in clusters with recurrent ear infections. They continued to increase in their daily frequency to greater than one hundred per day despite increasing doses of banzel and increased use of benzos. In addition, they were less responsive to use of the vns magnet. However, the notes also mention that the patient's mother was observed to be using the magnet incorrectly and was instructed on the correct use of the magnet during this office visit. The patient is experiencing nightime seizures which resolved with the addition of banzel; however, it was stated that it was unclear when they began to reoccur nightly. During the patient's last visit, the patient's lack of consciousness and multiple drop attacks of unclear etiology were noted resulting in patient hospitalization. During hospitalization, increased ammonia was noted. In addition, the patient was markedly responsive to iv, concluding that his presenting state was metabolic related. The patient's medication was increased and the eeg was conclusive for non-epileptic as well as epileptic events. At follow up, the patient's cognition was markedly improved over prior visits. In regards to the daily episodes of quick head drops that started a week prior, which had the semiology of non-epileptic events associated with hypoglycemia and increased metabolic needs. Attempts for additional information were made; however, they were unsuccessful. No additional information was provided.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2013. The generator was returned for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3192841
« Last Edit: April 26, 2018, 01:25:53 AM by dennis100 » Logged
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« Reply #18 on: December 17, 2017, 01:58:09 AM »

Model Number 102
Event Date 04/25/2016
Event Type Injury
Event Description
Clinic notes were received indicating that a vns patient was experiencing painful stimulation (a "shocking" sensation) for which the generator was disabled. It is stated that the painful stimulation stops when someone palms her in the back behind where the vns is placed. It is stated that when it shocks her it shocks her down her arm down to her elbow, in shoulder blade area, up into her neck, head, and teeth. She states that moving her left arm sets it off. The patient was then referred for generator replacement evaluation. Review of available data in the programming and history database revealed no anomalies. A battery life calculation performed with available data indicated the device has 8. 5 years remaining until neos = yes although the last 4 years of programming data is missing. Follow up with the provider indicated that the most recent device check was (b)(6) 2016 and when asked for battery status on that date the provider indicated the battery was "failing. " the provider indicated that vns was turned off until the battery could be replaced and increase seizure medication was prescribed until vns can be turned back on. The provider stated that the increase in anti-seizure medication was to preclude a serious injury since the vns device had been turned off awaiting generator replacement surgery although the patient had not actually experienced an increase in seizure. Further follow up with the provider indicated that while the clinic notes did not specifically indicate which battery indicator was observed the providers felt the patient's device was at neos or eos. The physician attributed the painful stimulation to the low battery condition and elected to disable the device output for patient comfort reasons. The provider submitted additional clinic notes containing device settings. An updated blc performed based on the newly submitted settings indicated that the device has approximately 8. 1 years remaining longevity. No device diagnostic data could be found in the clinic notes therefore the impedance status of the system was unknown. The device was subsequently evaluated and found not to be at eos and had normal lead impedance values in 3 different head/neck positions but the providers elected to proceed with generator replacement surgery on a prophylactic basis. The generator was successfully explanted and replaced on (b)(6) 2016 and normal impedance was observed with the new generator attached to the former lead (dc dc 2).

Manufacturer Narrative

Event Description
The generator was received for product analysis. During analysis there were no performance or any other type of adverse conditions found with the pulse generator and the generator performed according to functional specifications. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. 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 device had not reached an neos or eos condition. No new events have been reported following device replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5689538
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« Reply #19 on: December 18, 2017, 01:50:31 AM »

Model Number 103
Event Date 04/12/2016
Event Type Injury
Manufacturer Narrative
Corrected data, supplemental mdr #1 inadvertently reported that the patient had a replacement while the surgery was only an explant surgery.

Event Description
It was reported on (b)(6) 2016 that the physician saw the patient that day and she was complaining of painful erratic stimulation in her left neck when she turns her head to the left. This started about 1 week prior and there was no trauma or event that seemed to have started it. The physician checked diagnostics with her facing forward and also turning her head to the left. Notes state to follow-up to replace vns / lead if malfunction continues but this likely refers to the painful stimulation as diagnostics showed the vns was functioning well and physician lowered settings to help tolerability. No malfunction of the device was observed. The patient is now scheduled for an explant of the device. Surgery has not occurred to date.

Event Description
The patient generator was explanted (b)(6) 2016. Clinic notes were received on 10/21/2016 for the patient to be re-implant with a m106. The notes state that the previous vns stimulator was removed (model 103) because painful stimulation was triggered by turning head towards it and she has to turn her entire body not just head to avoid trigger of vns stimulation. The electrodes are still in place but the surgeon suspects the electrodes may be fractured but he will check the old lead with the new vns during surgery to see if it¿s still working, otherwise he will implant new electrode. No additional information has been received to date.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was discarded after explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5653184
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« Reply #20 on: December 29, 2017, 02:08:08 AM »

Event Date 08/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on 08/17/2016 from the patient's mother that she was concerned that her daughter's generator battery may be depleted due to recent reports that she has had more seizure events. It was reported that this has only been occurring this month. The patient has been having a feeling of "pins and needles all over her head, arms, and legs" which also leads her mother to fear that her seizures may be returning. No additional information has been received to date.

Manufacturer Narrative
Supplemental mdr #2 inadvertently omitted information that changed the file from a malfunction to serious injury. Information was known prior to submission that intervention was taken for the adverse event.

Event Description
The patient underwent battery replacement on (b)(6) 2016 for battery depletion. The product was discarded after surgery is not available for return.

Event Description
On (b)(6) 2016 it was reported that the patient had not been seen since (b)(6) 2014. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5935884
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« Reply #21 on: December 30, 2017, 02:10:07 AM »

Model Number 102
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that vns patient has a numbing feeling on her left neck, face, head, and leg when the stimulation is on since more than one month. The patient could not talk due to cyanotic lip. The patient has 5 times of seizure where 3 were stopped by magnet. The physician reported that those adverse events are related to the stimulation and there is an increase in seizures (above pre-vns baseline). The patient parameters are currently at: 1. 75ma, 30hz, 250usec, 30sec on and 1. 8min off. Follow up indicated that the patient¿s parameters were changed to 1. 25ma; 250's; 30s on; 5mins off. The patient feels very little numb during stimulation. The patient will come back after 3 months for the next follow up visit. The drugs were not changed. The seizure start area in the brain is still unknown for the physician. It was observed that patient has abnormal signals from eeg results (from the frontal-temple lobe). Further follow up indicated that the vns system works fine. Numb feeling disappeared after the parameters decrease. However; the patient has several general seizures after this parameters change. Cyanotic lips happen only during general seizures without direct relationship with the stimulation, and are contributed by the seizures (physician thinks not related to the vns). It was reported also that the increase of seizures maybe related to vns or drug change (medicaments changed/not taken by patient without physician's permission).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6016651
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« Reply #22 on: January 05, 2018, 04:24:12 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 11/11/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient was observed overnight at the er complaining of painful stimulation. And continuous stimulation. The mom said she was feeling burning in her head. The physician requested the device to be turned off. Follow-up to the physician at the hospital provided that use of the magnet to disable the device was tried and did not resolve the issue. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7092861
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« Reply #23 on: January 11, 2018, 02:24:23 AM »

Model Number 302-20
Event Date 08/08/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103125
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« Reply #24 on: January 14, 2018, 01:49:09 AM »

Model Number 102
Event Date 03/01/2009
Event Type Injury
Event Description
It was reported that the patient was experiencing pain when she turned her head to either side. Patient had her device turned off in 2009 to see if it would resolve the pain. Patient also saw a surgeon who said he will consider surgery if the pain does not resolve with the device turned off. Physician believes the patient's reported events are a result of a fall she had a few months ago, but it is unknown if it is related to vns. No casual or contributory programming or medication changes preceded the onset of the reported events. Attempts for further information have been unsuccessful to date and surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520016
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« Reply #25 on: January 18, 2018, 02:50:39 AM »

Model Number 303-20
Event Date 04/01/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.

Event Description
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667369
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« Reply #26 on: January 21, 2018, 03:27:48 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the pt was to have her vns device removed for an unk reason. Follow-up with the treating physician reveals that the pt was experiencing a "shocking" sensation when she turned her head to the left. X-rays were taken and reviewed by the manufacturer. Upon review, no anomalies were noted with the device. Pt underwent surgery to replace the generator on (b) (6) 2010. Per treating physician, the surgery was prophylactic and there were no functional problems with the generator either before or after surgery. However, the surgeon felt the surgery was performed to preclude a serious injury as the pt was feeling "shocking" which could have caused injury. The surgeon felt the shocking was due to the generator nearing end of service. No trauma or manipulation occurred and no causal or contributory programming or medication changes preceded the onset of the shocking sensation. Per treating physician, the shocking sensation has resolved since surgery. Product has been returned to manufacturer, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692487
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« Reply #27 on: January 22, 2018, 02:12:09 AM »

Model Number 302-20
Event Date 05/17/2010
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
A vns pt's treating physician reported that system diagnostic testing on one of his vns pt's yielded output: limit, dcdc 7 and lead impedance high, eri no. Normal mode diagnostics resulted in the same. Additionally, it was reported the pt has been having a little shocking sensation sometimes occurring when she turns her head also occurring spontaneously. The pt denies any trauma, which may have caused the high impedance. The physician was provided recommendations to program the vns off. At this time, good faith attempts have been unsuccessful for further details about the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1773831
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« Reply #28 on: January 25, 2018, 02:36:57 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated a vns pt was having head movements thought to be seizures in 2008. After the vns settings were decreased, the head movements improved. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1822573
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« Reply #29 on: January 30, 2018, 02:27:17 AM »

Model Number 103
Event Date 07/28/2010
Event Type Malfunction
Event Description
It was initially reported in a patient's clinic notes that on (b)(6) 2010, the patient's settings were 1 ma/25 hz/250 microsec/14 sec/3 min. The doctor noted that the patient's vns current was "increased back to 1. 25 ma. However, when the system was reprogrammed the default settings were restored and the pulse width jumped to 500. [the patient] received one stimulation at this current strength and width and had significant symptoms. He had pain in his neck and pain in his head. He coughed and had difficulty catching his breath during the coughing. The device was immediately interrogated again and the settings were returned to the previous settings and he tolerated that well. The device was again interrogated to assure that it had returned to its typical settings. [he] recovered from the strong stimulus and was again himself within moments. " good faith attempts to gain more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061986
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« Reply #30 on: January 30, 2018, 02:28:44 AM »

Model Number 103
Event Date 11/12/2010
Event Type Injury
Event Description
It was reported by a pt through a company representative that since vns surgery, she has been having head and neck pain. The pt was admitted to the hospital and was treated for pneumonia. The pt was then released with oxygen saturation in the 80s according to the patient's sister. At the moment, the patient's device remains off and good faith attempts to obtain additional info from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936140
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« Reply #31 on: January 30, 2018, 02:29:36 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type Injury
Event Description
It was reported by a psychiatrist that a vns patient experienced pain going up the left side of the neck and down into the left shoulder with stimulation. Patient's current settings were 1. 75/20/500/30/5 and treating psychiatrist stated that diagnostics were all ok (no specifics) and have been in the past. The patient denies any trauma to the area. Additional information was received from the patient indicating that she is still experiencing painful stimulation only when her head is turned to the left. Patient stated that when her head is straight there is no pain. The patient stated she would like to see a surgeon to see if he can offer any solutions to the reported pain. However, at the time no interventions have been scheduled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919376
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« Reply #32 on: January 31, 2018, 01:47:47 AM »

Model Number 302-20
Event Date 01/17/2011
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by a vns pt that she experienced sharp pain in her neck when turning her head along with headaches with pain over her right eye. Add'l info was received from a company rep indicating the pt's treating neurologist had in his notes from (b)(6) 2010 that high impedance was noted. Follow-up was made with the pt treating neurologist and nurse. The nurse indicated that the pt was taken to an mri and results were normal for the pain and headaches, hence she did not know what caused the pain and headaches. No x-rays were taken for the reported high lead impedance and it was unk if pt manipulation or trauma contributed to the reported high lead impedance. Current plans were to increase the pt's vimpat and follow-up in 3 months as the pt's battery is dead. Review of the manufacturer's programming history database was not indicative of high lead impedance although history was limited to (b)(4) 2005.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2036841
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« Reply #33 on: February 03, 2018, 03:04:50 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/01/2016
Event Type Injury
Event Description
Report was received that a patient had experienced painful stimulation during magnet activation. The magnet output current was reduced and the painful stimulation subsided temporarily. About 7 months later, the patient began feeling painful stimulation on the side of the head and ear with normal and magnet mode stimulation. No adjustments in therapy or trauma occurred prior to the reoccurrence of the painful stimulation. System diagnostics were performed and returned within normal limits. A review of the programing history did not show a presence of high impedance. A review of chest x-rays did not indicate there was any malfunction present. The patient was referred for a generator replacement because adjusting settings did not resolve the painful stimulation and the physician indicated he believed the generator was malfunctioning. No surgical intervention has occurred and no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6801108
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« Reply #34 on: February 04, 2018, 02:12:37 AM »

Model Number 302-20
Event Date 03/01/2011
Event Type Injury
Event Description
It was reported by a vns pt that she felt dizzy with stimulation. Also, she indicated she had a pain in the back of her head and her vns lead had been implanted over a goiter that she had, so the lead was now protruding. Follow-up was obtained from the pt's physician's office and they stated the pt did not indeed get dizzy with stimulation; however, the pain's relationship to vns was not known. The device had been "checked" and the doctor's notes indicated "proper device function", although no specifics were available. The site stated that the lead was "not protruding per se", but that the doctor could palpate the wires in the pt's neck, and "everything seemed to be located where it should be". The pt was to undergo a ct scan angiogram to investigate the dizziness and pain further, but the doctor did not indicate that this was to preclude a serious injury. No changes were made to the pt's settings preceding the onset of the events, and no changes had been made when the device was checked. However, later info was given to a company rep stating the pt was referred to a surgeon as she had a lead that was protruding due to the goiter. The surgeon's nurse indicated that the pt may be explanted with no replacement. The pt subsequently underwent a replacement surgery where her generator was explanted. It was not decided if the lead would be replaced yet. Furthermore, it was stated that the issue was the pt's tie-down. During the surgery, the surgeon removed one tie-down and replaced the generator as there was "no issue with the lead at this time". Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063732
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« Reply #35 on: February 06, 2018, 02:28:23 AM »

Model Number 302-20
Event Date 01/01/2011
Event Type Injury
Event Description
On (b)(6) 2011, it was reported by a vns treating physician that the vns pt was experiencing some scarring around the lead and was being referred for a full revision surgery. The pt was not presenting with high impedance. The physician reported that the scarring started in (b)(6) 2011. The pt feels some pulling and it hurts him when he turns his head to the right; it feels like a pinch. The scarring is around the lead body and electrodes he is scheduled for surgery for scar revision (b)(6) 2011. Interventions are being taken for comfort and to hopefully prevent any injury that could occur because of the excessive scar tissue. The physician reported that there wasn't anything that happened that would have contributed to this condition. The physician provided clinic notes dated (b)(6) 2011 that state that the pt complains about pain and is tugging at the vns lead site on his left neck. He mentions the pain at least once per day. The pt has some scar tissue on his left neck. The pt's programmed settings are 1. 25/30/500/30/3/1. 5/60/500 with a systems test and a normal mode test reading ok/lead impedance = ok/dcdc = 2/ eri=no. When additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2088584
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« Reply #36 on: February 07, 2018, 03:15:34 AM »

Model Number 302-20
Event Date 05/09/2011
Event Type Injury
Event Description
It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129926
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« Reply #37 on: February 07, 2018, 03:16:31 AM »

Model Number 102
Event Date 03/01/2011
Event Type Injury
Event Description
The pt reported that his lead had slipped and is now in a knot. The pt reported that he is able to see the knot in his neck. Also, the pt reported being shocked with stimulation in the neck and ear. The pt saw his physician regarding the issue, and the was told the device "works. " the pt's settings were reportedly decreased on (b)(6) 2011 due to the shocking sensation, which has helped the issue. He had also been sent for x-rays and a surgery consult. Furthermore, the pt stated that prior to the setting decrease, the left side of his head had been numb; he had also been having an increase in seizure activity. The mfr's programming history was searched and the pt's last known settings were on (b)(6) 2010. Diagnostic testing on this date showed normal device function. Later info was rec'd indicating no trauma or manipulation had occurred. Recent diagnostics were stated as being "ok", and the pt was still having less seizures than before vns. No medication changes had been made prior to the increase in seizures. The site also said that there were no medication changes prior to the painful stimulation, but the pt's pulse width and frequency were decreased, and the pt then could tolerate stimulation. The physician indicated that the numbness that the pt had experienced was not related to vns. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133423
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« Reply #38 on: February 08, 2018, 01:56:50 AM »

Model Number 102
Event Date 06/24/2011
Event Type Injury
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case mgmt. Review of the clinic notes revealed that on (b)(6) 2010, the pt was experiencing pain in their neck and shoulders on and off. The physician decreased the vns pulse width to see if it would help the pt. The physician also reported that on (b)(6) 2011 the pt had seizures at night, but did not try and swipe their magnet. In clinic notes dated (b)(6) 2011, the physician reports that the pt has a history of neck pain. The physician also reported that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. Due to the pt's flare of symptoms, the physician referred the pt for prophylactic battery replacement. In clinic notes dated (b)(6) 2011, the physician provides further info about the pt's history of neck pain, stating that it spreads into the occipital area in keeping with neuralgia. The physician again reports that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. The mfr's consultant later reported that the physician believes the pt's pain was not related to vns. Surgery has not yet been scheduled. Attempts for additional info regarding the pt's seizures have been made to the physician, but no further info has been received to date. When further info is received, it will be reported. A blc performed with the programming history in the mfr's programming history database which revealed negative yrs until eri = yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180923
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« Reply #39 on: February 09, 2018, 03:11:36 AM »

Model Number 103
Event Date 07/04/2011
Event Type Malfunction
Event Description
Further information reveals the patient has a consult for the painful stimulation issue and a decision will be made on how to proceed. Attempts for further information have been unsuccessful to date.

Event Description
Decoder spreadsheet analysis was performed for the patient's vns programming history. A review of patient programming data revealed that on (b)(6) 2011 the initial interrogation of the device resulted in a measured battery voltage of 2. 849v, indicating that a 25% battery status indicator was displayed to the user during this interrogation (e. G. 25% remaining is displayed at measured voltages of 2. 85v with demipulse generators). All subsequent communication operations resulted in a measured voltage of 2. 68v at the same programmed settings, based on charge accumulation this would have resulted in the expected 100% status indicator. Based on this data, it is possible that battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life. The manufacturer addressed this issue with demipulse generators by adding a 0. 5v offset to measured battery voltage during the first 7. 5% of battery consumption to mitigate the potential for artificially low voltage measurements during this period. The fact that the voltage measurement of 2. 894v was received at 9. 560% of consumption may indicate that battery impedance for this particular generator was longer than most (e. G. An outlier). Based on all subsequent programming data the device appears to be functioning as intended.

Manufacturer Narrative
Analysis of programming history. The battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life.

Event Description
Further manufacturer investigation revealed that the root cause of the observed battery voltage behavior has been determined to be the result of either an extended duration of the reduced conductivity (i. E. High battery impedance) experienced by cfx batteries during the beginning of life (bol) or a minute internal short that managed to "burn" itself out resulting in the observed voltage rebound following 10% of discharge (e. G. Consumption). No change to risk has occurred as a result of this investigation, which continues to be "low. " change request numbers (b)(4) were created as a result of this investigation. (b)(4) proposes that the duration of the 0. 5v offset, implemented by the firmware for model 103/104/105/106 generators be extended from 7. 5% to 15% of consumption within 11. X programming software in order to mitigate such events in the future. (b)(4) proposes that this issue be mitigated either through the firmware (as the device is still under development) or through the programming software as well.

Event Description
It was reported that the pt started feeling painful stimulation at generator site a few weeks prior. Pt's current setting are 2. 5/30/500/30/5 magnet 30/60/500. Diagnostics were performed and results were within normal limits, 2595 ohms, ifi: no. The green light showing battery consumption was showing half full and the physician does not think this is correct. Based on pt's current settings, the pt's device should last about 4 years and half green light means the battery has 25% to 50% remaining battery life which is not expected. X-rays of the pt's device were taken and reviewed by the mfr. No anomalies were seen on the x-rays. The physician ran diagnostics with pt's head turned different ways. When the head was turned to the right, the pt did not feel painful stimulation, but when the head was turned to the left, the pt felt the painful stimulation. Diagnostics in all positions were ok. The physician lowered the settings and the pain resolved. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245770
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« Reply #40 on: February 09, 2018, 03:12:41 AM »

Model
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« Reply #41 on: February 13, 2018, 01:41:32 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 07/10/2017
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that this patient is experiencing vocal cord paralysis. The surgeon believes it might be due to the vns strangulating the nerve. Therefore a vns lead revision occurred to determine if nerve strangulation is the cause. It was later reported that the patient began having sharp pains up her left ear to her left suboccipital area when her output current was increased. The patient had numbness of her left neck, left throat and left tongue. This made swallowing difficult. This did not get better with time, and when the output current was turned back down, she did not feel any stimulation unless her head was tilted to the left. It was mentioned that the doctor reported that the patient's nerve was pretty sizeable. The sharp pain that led to the patient's ear and suboccipital area was occurring with stimulation. It was also reported that it was too early to know the cause of painful stimulation, numbness, and vocal cord paralysis. The doctor spent 8 hours in the operating room probing the patient to determine what to do, and decided to cut the anchor tether, and snipped off the end of the positive electrode, and per the doctor, he did not cut any wire. He also believed the negative electrode was kinked and he fixed that. Overall the doctor kept the implanted lead intact with some modifications. The patient's generator was programmed off to allow the nerve to rest after surgery. No additional relevant information has been received to date.

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« Reply #42 on: February 14, 2018, 01:44:39 AM »

Model Number 103
Event Date 02/23/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received indicating that the patient's painful stimulation started following her generator being programmed back on in (b)(6) 2011. During stimulation, the patient experienced pain in left side of neck that proceeded to back of her head. She also noted more pain during magnet activation. She does; however, have seizure control. The patient's settings were provided and diagnostics were also run with ok results, however, no specifics were provided. The physician then lowered the patient's signal frequency to 20hz and pulse width to 250usec. The patient's magnet mode pulse width was also adjusted to 250usec. Diagnostics were repeated and tested ok. The patient was able to tolerate both normal stimulation and magnet stimulation following these adjustments and stated it was much better. The patient also complained of chest discomfort at generator site which the physician felt it was due to scar tissue and not stimulation related. The change in patient settings was performed for patient comfort, and no other interventions are planned at this time.

Event Description
It was reported that the patient was experiencing constant burning at her generator site as well as a shooting pain into the back of her head, hot flashes, and trouble breathing when her device would go off. This started following her recent replacement in (b)(6) 2011. The patient was told that this may be due to a lack of fatty tissue and possible scarring. The patient has been referred for a generator, and possible lead replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2351767
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« Reply #43 on: February 21, 2018, 02:19:44 AM »

Lot Number 686260
Event Date 01/06/2012
Event Type Injury
Event Description
On the morning of (b)(6), i woke up with a shocking feeling in my head, accompanied by a migraine. When it didn't subside by monday the (b)(6), i decided to email the company that makes my vns, cyberonics. On tuesday the manager called me back and after telling him everything that was happening, he said to turn the device off and see if i still have the shocking feeling by taping my magnet to my vns for a few hours. After taping the magnet to the device, although the shocking went away, my skin started feeling like it was on fire. After removing the magnet a few hours later, the shocking feeling and migraine came back immediately, and there as a burn mark on my chest where the device is. Then on wednesday the (b)(6) i had to be taken to the hosp by ems for severe chest pains. The feeling still hasn't gone away. Frequency: on 30 sec off 1. 5 min.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2423729
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« Reply #44 on: February 25, 2018, 01:41:21 AM »

Model Number 102
Event Date 11/21/2006
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.

Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

Manufacturer Narrative

Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.

Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.

Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
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« Reply #45 on: March 08, 2018, 02:35:14 AM »

Model Number 304-20
Event Date 05/19/2012
Event Type Injury
Event Description
On (b)(6) 2012, the vns patient reported that she has been experiencing some post-operation surgery effects. The patient was implanted on (b)(6) 2012. The patient stated that the vns is protruding, the patient's voice is altered and is high, and the patient's head is turned away from incision mark 4 and there is redness around the site. The patient's mother stated that the patient had to go back to the hospital overnight on (b)(6) 2012 due to pain as the patient had a hematoma and could not turn his head to the left. The patient's voice was still impaired. The patient's mother stated that the patient is doing better now. The physician later stated that they have no explanation for why the patient couldn't turn his head to the left however; the physician did not believe it was due to vns. The pain is located on the right side. No interventions were planned or taken and on (b)(6) 2012 the device was turned on. The physician does not believe the pain is related to vns. The physician clarified that there is no protrusion; the patient's mother was worried because the events occurred right after surgery, but the physician stated that the patient is healing quite nicely. The patient's implanted product information has been requested from the implanting hospital but it has not been received to date.

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« Reply #46 on: March 09, 2018, 03:34:32 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/17/2018
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the patient was sick and ever since then she has started turning her head to the left and is keeping her eye closed. She is worried there might be a nerve issue or something wrong with the vns and maybe the vns is not working properly. It was later reported by the patient¿s mother that she was in the icu. She had severe seizures and in a sedated coma to stop the seizures, and the relationship to vns was unknown. Additional relevant information has not been received to-date.

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« Reply #47 on: March 10, 2018, 02:26:58 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/04/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing a tingling sensation at the electrodes that traveled from her ear to her head. Diagnostics were performed after the tingling started, and high impedance was present. The patient used the magnet to disable the device, and she planned on asking her physician to program it off. No 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=7262565
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« Reply #48 on: March 10, 2018, 02:28:13 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 08/25/2008
Event Type Injury
Event Description
It was reported that a vns patient would experience shortness of breath with exercise. The device was programmed off however the patient continued to experience shortness of breath and the patient was scheduled to have the device removed. The shortness of breath occurred sporadically and was not related to stimulation on times. Additional information received indicated that the patient suffers from anxiety and that was why the device was explanted. The anxiety is not related to vns and is pre-existing however the physician believed that due to the patient¿s anxiety, she could not handle being implanted with the device. The physician indicated that the shortness of breath could be related to the anxiety but was not sure. Additional information was provided that the device was explanted due to syncope and other complications. The explanting surgeon stated that at the time he noted that it was causing intermittent traction of the vagus nerve. It was noted that the patient also had increased heart rate. Clinic notes dated (b)(6) 2008 (a few months after implantation (b)(6) 2008), it was noted that since vns was implanted, before it was turned on, the patient has complained of shortness of breath and exercise intolerance (this may have been why the patient had increase in heart rate). There was a note that the patient did have exercise induced asthma prior to vns implantation. However, the patient states that it specifically causes problems with her breathing and believes it is all because of the vns. The notes then go on to state that vns was interrogated and settings were 0. 5ma (changed from 30sec on to 60sec). Notes indicated that the physician tested the patient¿s pulse oximetry and pulse before turning the vns on. There were no notable changes and the physician stated that based on the results the physician did not think there was any obvious change both with exertion and at rest whether or not the vns was on. The patient was still quite upset so they elected to turn it off. Notes dated (b)(6) 2009 indicate the device has still been off since (b)(6) 2008 and the patient still has had problems of a sense of pulling in her throat, difficulty breathing, exercise intolerance, syncopal episodes, left facial numbness, all of which she reports are intermittent. She can reproduce some of these problems when she turns her head to the right for prolonged periods of time or when she pushes upon the sternomastoid muscle a few cm from the incision. This would be at the location of the lead itself. The surgeon assessed the patient and attributed that there is excessive traction on the nerve with turning of her head and most of not all of her other symptoms are likely related to intermittent traction on the vagus nerve. Surgeon offered surgical intervention to possibly increase the size of the strain relief loop in an attempt to ameliorate the traction that she suspects caused these issues. He also offered a more extensive option to remove the vns if she preferred. The patient decided to remove the device entirely on (b)(6) 2009. The entire system was removed including all 3 helical coils. Notes dated (b)(6) 2009 did state that the patient has had none of the symptoms she had previously. No additional or relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237189
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« Reply #49 on: March 15, 2018, 02:16:30 AM »

Model Number 302-20
Event Date 08/23/2012
Event Type Malfunction
Manufacturer Narrative
Device available for evaluation, corrected data:the supplemental report #2 inadvertently did not include the date in which the lead suspect device was received by the manufacturer.

Event Description
Patient reported on (b)(6) 2012 that she is doing well.

Manufacturer Narrative
Conclusion, corrected data: the supplemental report #4 inadvertently reported the incorrect conclusion code. No device failure is suspected. No device malfunction is suspected, and the (b)(6) 2012 x-rays did not show a lead fracture, so the event is coded as confirmed invalid. In addition, normal mode and system diagnostics were reportedly within normal limits.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

Manufacturer Narrative

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
An implant card was received by the manufacturer on (b)(4) 2012 which revealed that the patient had lead replacement surgery on (b)(6) 2012 due to "lead discontinuity. " the explanted lead was received by the manufacturer on (b)(4) 2012. However, product analysis has not been completed to date.

Event Description
Additional information was received indicating that the physician performed both normal mode and system diagnostics which resulted in okay results. They were perplexed because the diagnostics are okay but the x-rays show a partial lead break (which the physician and company representative also observed). A/p and lateral x-ray images of the chest and neck dated (b)(6) 2012 were also received by the manufacturer. The generator placement appears lower than normal in the left chest. Without images from immediately following implant surgery in (b)(6) 2010, it is difficult to assess whether the generator has migrated. The connector pin appears to be fully inserted inside the connector block, and the lead wires appear to be intact at the connector pin. The filter feed-through wires also appear intact. No portion of the lead appears to be located behind the generator. The electrodes were visualized in the neck and appear to be in the proper orientation. Unlike the previous images dated (b)(6) 2012, there do not appear to be any lead fractures in the chest area above the generator. No gross discontinuities or sharp angles are visualized in the images provided. However, a micro-fracture or unpronounced lead discontinuity cannot be ruled. It appears that there was likely an artifact in the images dated (b)(6) 2012 that made it appear as though there were two partial lead fractures in the chest area. Based on the x-ray images provided, no anomalies can be observed to account for the reported pain and potential generator migration. It can be noted that these are adverse events and not device malfunctions, and therefore, they are not expected to be observed on an x-ray. No gross lead discontinuities or sharp angles could be visualized, however an unpronounced lead discontinuity cannot be ruled out. No anomalies were identified that could account for the adverse event. The physician believes inadequate strain relief in the neck may be contributing to the patient's pain in the neck. She only gets the painful stimulation when she turns her head to the right. They believe the generator has migrated which may be pulling on the leads from the two tie-downs due to poor strain relief. The patient has received good efficacy from vns therapy. The physician believes the way to resolve this is to fix the strain relief, however, no interventions have been planned to date. Although surgery is likely, it has not occurred to date.

Event Description
Product analysis on the returned lead assembly was completed. The lead was returned in three portions. The connector pin, connector ring, and lead's electrodes were not returned for evaluation. The reported high impedance and lead discontinuity allegations were not verified within the returned lead portions. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
X-rays were received on (b)(6) 2012, by the manufacturer, and the radiology report indicated that the patient was experiencing neck pain. Review of the ap and lateral chest and neck x-rays, dated (b)(6) 2012 revealed that the generator can be visualized in the left chest and it appears to be in a normal orientation. The lead pin appears fully inserted into the connector block. The filter feedthru wires appear intact and the lead wires appear intact at the connector pin. The lead wire does not appear to be located behind the generator. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be two partial lead fractures in the chest area above the generator. No additional gross discontinuities or sharp angles in the images provided are visualized. Based on the x-rays received, there are two partial lead fractures present in the chest area which may be contributing to the pain. Follow up with the company representative revealed that the patient's pain was thought to be the same pain the patient experienced before in the neck and shoulder area in 2011 due to generator migration and patient trauma from a car accident (before the physician was aware that there appears to be two partial lead breaks). The physician believed the pain may be related to the generator migration or potentially scar tissue at the electrode site which may be making the strain relief less prominent during neck movement. However now, the pain occurs during stimulation and when she turns her head ot the right or left. The plan is to discuss this with her on the next visit and evaluate if surgery may be needed. The physician suspects that the strain relief may or may not be present anymore due to scar tissue or it may be pulling the lead wire back into the neck area. The physician reported that all diagnostics are within normal limits, and he does not think there is a lead break but only associated with the strain relief. It could have had more of a strain relief and then when the generator migrated, caused a less prominent strain relief. If the pain is still present and it is decided to pursue surgery, the physician and company representative indicated that he would suggest to open up the pocket and neck, move the generator higher in the pocket, capture the lead wire and make a proper loop/strain relief. The physician did not know when the patient will be seen next and does not know how much dysfunction the pain is causing her. The pain does not occur every time during stimulation and is not constant, but only when she turns her neck. The device had not been turned off to date as of (b)(4) 2012. Attempts for additional information have been unsuccessful to date thus far.

Event Description
The return product form indicates that the reason for lead replacement on (b)(6) 2012 was due to lead discontiuity. Product analysis on the explant lead has not been completed to date. The generator was not replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2754445
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« Reply #50 on: March 19, 2018, 02:00:58 AM »

Model Number 302-20
Event Date 09/11/2012
Event Type Malfunction
Event Description
The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

Event Description
It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784912
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« Reply #51 on: April 03, 2018, 01:11:56 AM »

Model Number 304-20
Event Date 11/06/2012
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high lead impedance (>7000 ohms, neos - no). The high impedance was seen when the physician interrogated the patient's device and a high impedance warning message was received. The patient had been doing some heavy lifting while moving apartments. Following this he began experiencing some pain on the left side of his neck, head and shoulder. The pain was described as constant throbbing which was not relieved with tylenol. The patient can into the physician office for an appointment related to his and the high impedance was seen. The patient had their setting turned down and them off and the high impedance remained. The physician chose to turn the patient back on as vns has helps with seizures. The patient was referred for x-rays. X-rays will not be provided to the manufacturer for review. The physician reviewed the x-rays and there were no lead breaks visualized. The patient also had a more intense seizure about the same time of the move. The physician increased his dose of keppra and asked him to get his level checked. It was determined that his keppra level was low. He did not have any more seizure at the time of the report to the manufacturer. It is unknown by the physician if the more intense seizure was related to vns or the high impedance. The patient had a generator and lead replacement. Good faith attempts for product return have been unsuccessful to date.
 
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications as defined in (b)(4). The battery, 3. 012 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 11. 119% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Note that the electrodes were not returned for analysis; 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, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2911574
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« Reply #52 on: April 04, 2018, 01:17:59 AM »

Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Event Description
Additional information was received which indicated that the voice alteration was occurring with stimulation, there were no change in medication, and the increased impedance was seen on the vns device diagnostics, but there were no visible lead fractures in x-rays. There was no patient manipulation or trauma that might have caused the lead impedance. After the full revision the patient's seizures are now gone. The patient's settings on (b)(6) 2013 are output current= 0. 25 ma/ frequency= 15 hz/ pulse width= 130 usec/on time= 30 sec/off time= 3 min / magnet output current= 0. 5 ma/ on time= 60 sec/ pulse width= 250 usec. The device history report for the 302-20 sn (b)(4) was reviewed. No unresolved non conformances were found.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient had high impedance upon interrogation of her vns device on (b)(6) 2012. It was noted that the patient was last seen on (b)(6) 2012. The patient had been experiencing pain and soreness over the chest during stimulation which started on (b)(6) 2012 when the patient went to the er because she was experiencing burning in the neck. On (b)(6) 2012 it was stated that the patient had a fall approximately 1 week prior and the physician was uncertain if it was related to the patient's pain. At that time the patient described "mouth vibrations", chest pain near the generator radiating to her teeth head and arm with electrical qualities. Per the physician, an x-ray at that time did not show any gross lead fractures. On (b)(6) 2012 the pain was said to radiate to ear when the device stimulates and it was stated that the patient had discomfort when lifting her left arm. When the device was disabled the discomfort was gone. It was also indicated that the magnet had become more painful recently. Additionally it was noted that the patient had been experiencing an increase in seizure frequency. It was indicated that the patient usually experiencing 4-5 seizures per month when sleepy, however she had started experiencing 2-3 per month during the day as well as an increase in staring spells. The patient was referred for and underwent a full revision on (b)(6) 2012. A review of available programming history for the patient's generator was performed and diagnostic results in (b)(6) 2012 were within normal limits. Attempts for additional information and product return are in progress.
 
Event Description
An implant card was received on (b)(6) 2013 indicating that the reason for the replacement was due to an adverse event. The impedance from the date of surgery was not provided. Per the hospital's policy the hospital will not return explanted devices without a signed consent form and the patient, however the physician's will not ask for the signed release; therefore the product will not be returned. Attempts for additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410

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« Reply #53 on: April 07, 2018, 01:14:55 AM »

Model Number 304-20
Event Date 04/03/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient was in a car accident on (b)(6) 2014 and sustained a neck injury. The patient had neck pain and immediately had a seizure following the car accident. The patient had been seizure free for nearly a year prior to the car accident. The patient¿s device settings were increased during an office visit on (b)(6) 2014. The patient¿s neck pain worsened with stimulation. The patient began having head and ear pain. The patient also began experiencing voice hoarseness, occasional drooling, and head tilting with stimulation. (the patient pulled her neck toward her chest during device on-times. ) x-rays were taken and were reported by the physician to be unremarkable. The patient¿s device settings were decreased during an office visit on (b)(6) 2014. The patient subsequently had four generalized convulsions within 24 hours. The patient¿s device settings were increased during an office visit on (b)(6) 2014 and the patient was able to tolerate her adjusted device settings. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
New information changes the suspect device.
 
Manufacturer Narrative

Event Description
Additional information was received stating that, despite normal diagnostic results, the vns patient¿s lead was replaced due to the patient¿s increase in seizures following the motor vehicle accident. Furthermore, it was reported that the patient did not have a history of acid reflux. The reported acid reflux is believed to be related not to stimulation but to the patient¿s psychosomatic issues. Lead replacement surgery occurred prior to the onset of the acid reflux.
 
Event Description
It was reported that the patient's symptoms resolved after lead replacement surgery.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The patient¿s generator was not replaced. The explanted lead has not been returned to date. Further follow-up revealed that the patient¿s device was tested during an office visit on (b)(6) 014 and diagnostic results showed normal device function. The patient was concerned that there was a potential relationship between vns and the patient¿s acid reflux. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Corrected data: this date on follow-up mfr. Report #03 inadvertently reported the incorrect year. The date should have been reported as 07/28/2014. The report was not a late submission.
 
Manufacturer Narrative
The previously submitted mdr inadvertently did not include information regarding the reason for lead replacement surgery and the patient¿s acid reflux. The previously submitted mdr inadvertently did not include that no device failure is believed to have occurred as diagnostic results showed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854244
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« Reply #54 on: April 08, 2018, 01:09:18 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 02/20/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to pain shooting up her neck and back of her head that had been occurring for a few hours. The patient also had spasms and twitching on the left side of her body. The physician wanted to disable the device, so instructions on how to use the magnet to disable it were given. The patient was then admitted to the icu and intubated due to unknown reasons, and it was reported that most of the patient's seizures were pseudo-seizures. The physician stated that the patient was reporting that her vns was misfiring, but he did not seem to believe the patient based on her report of false seizures. Because the patient had no insurance or following neurologist, the physician requested that the device be programmed off until it could be properly managed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343586
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« Reply #55 on: April 12, 2018, 12:54:13 AM »

Model Number 106
Event Date 09/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been experiencing an increase in seizure frequency and duration. The patient had two 4-minute seizures in one month and it was noted that the length of the seizure was unusual for the patient. The patient had also been experiencing hyperventilation and reported that his head was not feeling well. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient¿s issues were not related to vns but to an endocrine problem that resulted in a loss of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4309662
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« Reply #56 on: April 15, 2018, 12:40:09 AM »

Model Number 304-20
Event Date 02/04/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a patient was seen urgently on (b)(6) 2013 after having 3 strong seizures in which the patient's head was turned to the right. The word "pledget" was used to describe strain in the vns lead wire with the neck muscle. The patient's device is currently disabled for 10-14 days and then the patient was to have the device re-tested. X-rays did not visualize the top of the lead wire but the area observed did not show any overt breaks per the reporter. All attempts for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated the patient's lead-pulling sensation was possibly due to the patient's strong seizures which may have caused inflammation along the lead wire. There was no specific patient trauma experienced other than the previously reported strong seizures which may have been the cause. The vns was disabled for two weeks, and then turned back on (b)(6) 2013. There have been no issues reported since that time. Current diagnostics are within normal limits. The "pledget" noted is felt to be the tie-down securing the lead in the neck.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2987998
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« Reply #57 on: April 26, 2018, 01:26:49 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that the vns caused the patient's gastroparesis, and their seizures were still not controlled. It was stated that the device didn't work for the patient and was therefore it was turned off. Scar tissue formed in the patient's neck, which was very painful, even to turn their head just a little bit was reported to be torture. Patient reported undergoing surgery to remove device and scar tissue. Patient also reported that there was damage to the vagus nerve. The patient's neurologist who managed the patient's vns did not know about any of the symptoms or issues. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7008994
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« Reply #58 on: April 27, 2018, 02:06:29 AM »

Model Number 102
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
The explanted device was returned on (b)(4) 2013. In (b)(6) 2013 notes, a system diagnostics test was also performed which showed results within normal limits and eos=no. Therefore, the event coding was not updated to indicated neos. Although the reported allegation of ¿change in seizure pattern¿ and ¿increased seizures¿ listed in (b)(4) cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications as defined in final electrical test (b)(4). During the product analysis there were no anomalies found with the pulse generator. Attempts for additional information were unsuccessful.
 
Event Description
On (b)(4) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2013 indicated that the vns patient has experienced clusters of myoclonic seizures and head drops since (b)(6) 2012. It was stated that the myoclonic seizures were occurring 2-4 times a day but now he has them once a day. It was also stated that patient has been experiencing myoclonus seizures twice per week which the mother thinks is new, but previous clinic notes indicate longstanding myoclonus. The patient¿s vns settings were noted to be output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec. A system diagnostics test was also performed which showed results within normal limits and eos=no. The clinic notes also mention that the patient is experiencing an increase in the frequency of his tonic seizures, especially at night. The patient was referred for generator replacement for an unknown reason. Additional information has been requested from the patient¿s physician but no further information has been received to date. A battery life calculation was performed which showed 5. 74 years remaining until eri=yes.
 
Event Description
Additional information was received that the patient had a generator replacement. Attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3192307
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« Reply #59 on: April 28, 2018, 12:55:07 AM »

Model Number 304-20
Event Date 05/23/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received indicating that cultures returned positive for (b)(6).
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization and confirmed all quality tests were passed for both the generator and lead prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent revision surgery on (b)(6) 2013. It was reported that the device "worked 100%". It was later reported that the patient was seen for checkup and that it was found that the patient has a "broken lead". It was reported that during the office visit diagnostics were performed with the patient's head a different orientations. It was reported that when the patient turned his head to one direction high impedance was always observed. Then the patient turned his head the opposite direction the impedance was "ok". The patient was referred for surgery and the device was programmed off. Surgery is likely, but has not occurred to date.
 
Event Description
It was reported that this vns patient underwent surgical debridement (without disconnecting the generator) due to chronic inflammation in the surgical wounds in the neck and chest. The patient was seen for a vns check, and system diagnostics indicated high impedance (10000 ohms). The device was disabled. During the operation, unipolar electric fields were used. It was believed that the patient had a damaged generator, lead, or both. The patient was referred for surgery. Follow-up showed that the chronic inflammation was believed to neck granulation that was first seen a few weeks prior to surgical intervention. The physician stated that diagnostics prior to the surgery were within normal limits; however, afterwards, they indicated high impedance. No x-rays were taken. Cultures were taken at the wound sites; however, the results have not been provided. Surgery is likely but has not taken place. No additional information has been returned.
 
Manufacturer Narrative
Previously submitted mdr inadvertently omitted the outcome of culture results. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3173892
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« Reply #60 on: May 06, 2018, 01:51:27 AM »

Model Number 102
Event Date 03/01/2013
Event Type  Injury   
Event Description
It was reported that the patient's generator was turned back on since the previous report. No additional pertinent information has been received to date.
 
Event Description
The physician's nurse indicated that the patient has no follow-up appointments scheduled at this time. The nurse suspects that the patient will begin to experience an increase in seizures with the device programmed off and will likely call and schedule an appointment. It was reported that the patient is only seen about once a year. No further information has been provided.
 
Event Description
It was reported that since an increase in device settings from 1ma to 1. 25ma, the patient has been experiencing shocking sensations with device stimulation at night. It was reported that diagnostic testing performed on (b)(6) 2013 showed ok impedance (dc dc code 2). The patient indicated that the shocking sensation is more noticed when his head is turned a certain way. The patient requested that his device be programmed off which was done per his request. It was reported that the patient denies any trauma that may have contributed to the high impedance reading; however, the physician's assistant reported that the patient may not be completely honest. It was reported that the physician's assistant wanted the patient to go for x-rays; however, the patient declined. It was reported that the patient will be seen again in a couple of months and that at that time, it will be determined whether or not the device will be programmed back on.

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« Reply #61 on: May 12, 2018, 01:30:49 AM »

Model Number 304-20
Event Date 10/04/2013
Event Type  Malfunction   
Event Description
Clinic notes were received for the vns patient office visits with his neurologist. Notes dated (b)(6) 2013 indicate that the patient had several breakthrough seizures since his last office visit with the most previous one occurring on (b)(6) 2013. The patient had one seizure at school consisting of generalized shaking of the extremities which appeared to slow or stop after magnet mode stimulation was activated. The patient's mother stated that the patient was having seizures throughout the night due to his drowsiness during the day. The patient continued to feel dizzy especially with physical activity. The patient had 2-3 head drops since his last office visit that occurred after having seizures while sleeping. The patient was able to feel when he was having a seizure and used the magnet frequently. The patient had different types of seizures over the past year: head drops lasting 10 seconds; generalized twitching of his extremities lasting 10-60 seconds; and clonic seizures lasting 15-30 seconds. The neurologist stated that overall the patient had an improvement sinc vns implant as the duration of his seizures had decreased significantly. The patient's device settings and medication was increased during the office visit. The neurologist stated that patient's wrestling with his siblings may have contributed to the high impedance observation. X-rays were taken during the office visit and were reported by the physician to be unremarkable. The patient's device was not disabled following the high impedance observation. Notes dated (b)(6) 2013 indicate that the patient had another seizure that lasted approximately one minute since his last office visit. The patient's device was tested during the office visit while the patient was sitting, lying, and turned his head. Diagnostic results from all the positions showed normal lead impedance. The neurologist stated that a microfracture may be a possible reason the high impedance observation at the previous office visit. Notes dated (b)(6) 2014 indicate that the patient had several seizures the week prior to his office visit. The patient's seizures were occurring at night. The patient's mother stated that the seizures would last approximately 10 seconds although she did not witness them. It was reported that magnet mode was activated but did not help in stopping the seizures. The patient's device had previously helped the patient reduce the duration of his seizures and postictal phase. The patient's medication was increased during the office visit. The patient's device was tested during the office visit and diagnostic results showed high lead impedance (impedance value >= 10,000 ohms). The patient's device was subsequently disabled. Notes dated (b)(6) 2014 indicate that the patient had three seizures in the past four weeks. The seizures were much milder and consisted of shaking of his entire body for 30-40 seconds. The patient also had 1-7 head drops that occurred throughout the day. The patient's device was tested during the office visit and diagnostic results showed high lead impedance. The patient's medication was increased during the office visit. Further follow-up revealed that the patient did not respond well to vns and the patient's seizures may be due to a combination of factors. X-rays were taken and were reported by the physician to be unremarkable. The x-rays will not be provided to the manufacturer for further review. The patient was seen prior to the his office visit in (b)(6) 2013 and diagnostics showed normal device function at the time. The patient was referred for replacement 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.
 
Event Description
Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested at several positions and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
On (b)(6) 2013 it was reported that the patient was seen by the physician that day and upon running diagnostics, high impedance (impedance value greater than 6200 ohms) was observed. This was when the patient was in the upright position. The physician had the patient lie down and ran diagnostics again, which showed the device was okay with impedance value of 3200 ohms. The patient was again re-positioned into an upright position. Diagnostics performed while the patient was in the upright position again showed high lead impedance with impedance value greater than 6200 ohms. It was confirmed that the patient had no trauma, no falls, and no manipulation. The patient went to have x-rays taken and it was stated that the vns device would be disabled to 0ma that day. Additional information was received that the patient's mother reports that the patient had an increase in seizures over the last two weeks, but not above baseline levels. The x-ray results indicated that there was no fracture. No other information has been provided.

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« Reply #62 on: May 13, 2018, 12:40:11 AM »

Model Number 302-20
Event Date 11/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, a physician reported that he was unable to interrogate a patient¿s device over the last few weeks. The patient stated that he could not feeling stimulation and his voice was not changing, so he doesn't know if his device was working. The physician did not believe the device was at end of service. The patient was seen again on (b)(6) 2013, at which time system diagnostics showed high impedance. The patient¿s device was disabled on (b)(6) 2013 as the patient was experiencing pain in the lower head. The patient was also the programming system was verified to be functioning properly and did verify the high impedance. On (b)(6) 2013, the patient underwent surgery. The generator was replaced, and a system diagnostic showed normal impedance (2000 ohms). Diagnostics after the patient was closed were also within normal limits. System diagnostics later in the day showed high impedance. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
The settings of the new generator were lowered, and the patient may be referred for lead revision at a later date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3534338
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« Reply #63 on: May 15, 2018, 08:25:39 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808957
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« Reply #64 on: May 21, 2018, 01:37:27 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

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« Reply #65 on: May 31, 2018, 02:14:38 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that x-rays were performed because the patient's device was not working. X-rays were sent to manufacturer for review. Review of the x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out. Further follow-up with the physician identified that high impedance (dc dc code - 7) was observed. It was reported that the patient had complained of discomfort and burning at the back of the throat. It was reported that device frequency was reduced from 25hz to 20hz for the discomfort. The patient reported that the discomfort and burning began approximately two months prior and occurs with device stimulation. The patient mentioned that the pain and burning worsens when moving the head from side to side. The patient denied and trauma that may have caused or contributed to the high impedance. The physician reported that the device was programmed off and the patient would be referred for surgical consult. No surgical intervention has been performed to date.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity and battery depletion. It was reported that the explanted devices were sent to pathology and disposed of. No product analysis can be performed.

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« Reply #66 on: June 03, 2018, 07:44:19 AM »

Model Number 102
Event Type  Injury   
Event Description
Reporter indicated that the pt had begun having an increase in seizure activity, and had been having more "head drops" which the mother feels is what happens when the generator battery is depleted. The treating neurologist stated that the generator was tested and showed the battery to be working properly at the time of the report. The pt has since undergone a generator replacement surgery which was stated as being due to end of service. The explanted generator has been returned to the manufacturer for analysis, but analysis is not yet complete. All attempts for further info from the treating physician have been unsuccessful to date.

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« Reply #67 on: June 13, 2018, 12:11:12 AM »

Model Number 102
Event Date 10/06/2008
Event Type  Injury   
Event Description
Reporter indicated a vns therapy patient is experiencing pain that goes up her neck and up the skull. The patient "has been fainting quite often so she would fall. " according to the patient, the physician said the fainting is "related to her bp levels. " she stated that her bp will sometimes shoot really high and her pulse will drop really low. Good faith attempts to obtain additional information have been unsuccessful to date.

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« Reply #68 on: June 15, 2018, 01:15:58 AM »

Model Number 304-20
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was recently turned on a few prior and was now experiencing some swelling in her neck and throat, and has been unable to turn her head. It was said that the patient was diagnosed by her treating neurologist that she has a neuroma. The patient was said to have been given a steroid injection, which provided some improvement. It was also indicated that the patient is experiencing some painful stimulation in the neck. No further details have made available on the events. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698103
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« Reply #69 on: June 19, 2018, 01:05:17 AM »

Event Date 02/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the company representative that he was informed by the physician that the patient showed high lead impedance at the office visit after a battery replacement surgery. Patient is also having an increase in seizures now. Seizures were well controlled prior to battery replacement. Patient was taken into surgery ((b) (6)2010) for the high lead impedance. His connector pin was re-inserted and diagnostics showed within normal limits in the operating room. Patient then had his appointment with the neurologist and showed high lead impedance again. However, when the patient turns his head to the right then, the diagnostics are within normal limits. It was suspected that the lead issue was positional. Patient will likely have another revision surgery. Good faith attempts to obtain additional information have been unsuccessful till date.
 
Manufacturer Narrative
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=1689709
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« Reply #70 on: June 23, 2018, 12:17:30 AM »

Model Number 304-20
Event Date 09/24/2014
Event Type  Injury   
Event Description
On 5/17/16 the physician reported that the patient did have a portion of their vagus nerve removed and then stitched back together again on (b)(6) 2014 during the full revision surgery that day.
 
Event Description
On (b)(6) 2016 the physician indicated that the patient's chocking sensation is from misfiring of the vns. He said that the memory issues are not applicable. All diagnostics were reported to be within normal limits with the last one performed on (b)(6) 2016. The physician turned off the patient's vns and the patient is considering having it removed and probably not replaced. The patient does not have a medical history of these events prior to vns. The only event preceding the onset of the chocking/painful stimulation is replacement of the vns. It was previously reported that the patient underwent a full revision on (b)(6) 2014 due to issue following a mammogram. The patient is still having discomfort in the neck with stimulation, so the physician indicated that he would like contact information for a vns surgeon for another opinion as the previous surgeon stated he would not do another revision for the patient. It was reported that a system diagnostics test had not been performed after the recent complaint of painful stimulation. Additional information was requested from the physician but no further information was received regarding whether diagnostics were performed since the replacement. On (b)(6) 2016 the patient's mother reported that the patient has been experiencing painful stimulation as well as profound breathing issues since the generator revision. The breathing issues are described as a strong choking sensation leading to gasping and can last up to 30 seconds at a time. The patient then reported that this issue typically presents when she turns her head to the left or the right and that it has happened "thousands of times" so she is used to the effects. She also is experiencing memory issues. The patient stated that she is now having an increase in seizures since her device was turned off on (b)(6) 2016. She said that at this time, she wants her system replaced because of the shocking and not wanting to have the stimulation turned back on. The patient noted that the magnet is still programmed on. She then indicated that she never had a problem with the previous system and when it was turned on following replacement, she started to feel shocking that was more over the generator site in the shoulder. The issues were also indicated as not occurring with stimulation on-times but always happened and resolved when the generator was programmed off. The patient said that her phrenic nerve is being stimulated per her neurologist, but it wasn't clear how he determined this. She indicated that when the magnet was swiped the day after it was painful, which is why she doesn't want to turn it back on. The patient stated that there is no room on the nerve because the surgeon removed part of her vagus nerve and stitched it back together, which she was insistent that this occurred as the surgeon told her this. The patient said that the old system was completely removed according to the x-rays. On (b)(6) 2016, a physician reported that the patient was hospitalized due to the increased in seizures. He said the primary reason for disablement was painful stimulation, shocking in her neck that occurred when she turned her head.
 
Manufacturer Narrative

Manufacturer Narrative
Inadvertently reported incorrect age on initial report.

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« Reply #71 on: July 13, 2018, 02:31:41 AM »

Model Number 302-30
Event Type  Injury   
Manufacturer Narrative
Information was incorrectly reported on the initial mfr. Report.
 
Event Description
It was reported the patient will have a vns generator replacement due to end of service, but the patient's mother would also like the lead replaced because she thinks the lead was compromised and is causing the patient jaw pain, head pain, and lower back pain. However, clinic notes from the physician were received and it was noted the patient has trigeminal neuralgia. The painful events are described as daily episodes lasting for hours. The pain starts in the patient's left lower jaw, where previously a tooth had been pulled, followed by midline low back pain, and frontal headache. The patient was seen in the epilepsy monitoring unit in 2013 and it was found that these events were not seizures. It was noted the patient does have trigeminal neuralgia, but replacing the lead will ensure the vns is not causing the pain. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
It was reported by the physician's office the patient's surgery will be for patient comfort. It was also noted the patient did not sustain any injuries from vns and trigeminal neuralgia is believed to be the cause of the patient's pain.
 
Event Description
It was reported by the patient's physician that the patient had transferred to a new neurologist. The new neurologist was contacted about the patient's issues and it was noted that the patient would not be referred for an additional surgery. It was also stated the pain is not related to vns and could be trigeminal neuralgia. The patient's vns was programmed off.
 
Event Description
It was reported the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was confirmed to be neos = no. The lead impedance with the new generator was noted to be ok at 1408 ohms, which is within normal limits. It was noted that the surgeon only replaced the generator. It was later reported by the mother that the patient's vns was implanted for 12 years and it worked great. In 2011, the patient had a tooth on the left side that rotted and was removed. Two weeks after the tooth removal, the patient began having "episodes" of pain which began to occur daily. The patient was placed in the emu (epilepsy monitoring unit) and it was found these "episodes" were not seizures. The mother reported the physician thinks it is related to nerve damage. After the generator replacement on (b)(6) 2016 the patient reportedly had an "episode" which lasted 5 hours on (b)(6) 2016, and another which lasted 8 hours the next day. The mother believes the episodes are caused by vns and she wants her daughter to have a lead revision. It was noted the surgeon does not want to replace the leads without evidence there is a problem with the lead, since the diagnostics are currently ok. The mother stated she wants the patient's neck site opened to see if there could be anything affecting the lead. It was noted that a ct scan was performed, but it did not show any abnormalities. It was reported that the mother had also called the patient's physician and noted the patient is having severe jaw pain and has been seen in the er. Product analysis for the explanted generator was completed. The generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
It was later reported that the patient used her magnet to turn off the device and the pain would go away. It was noted by the patient's mother that the settings were lowered from before and the patient's pain did subside. It was then that is was explained to the patient that the magnet could also be used to disable the device.

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« Reply #72 on: August 02, 2018, 01:45:06 AM »

Model Number 300-20
Event Date 01/01/2010
Event Type  Malfunction   
Event Description
It was reported that the pt had full revision surgery due to a lead discontinuity. Prior to surgery, the pt had stated that he did not feel stimulation anymore. High impedance was also found on diagnostics. During surgery, the physician visualized a lead fracture just below the electrodes. The physician feels that the break may have been caused by the pt's constant head movement back and forth. Products have been returned to the manufacturer, but analysis is pending. Attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #73 on: September 05, 2018, 08:15:13 AM »

Model Number 102
Event Date 07/04/2011
Event Type  Injury   
Event Description
Additional information was received from the surgeon indicating that the device was failing and no longer working for the patient. Diagnostics, performed since the onset of this issue, have been found to be normal, indicating that device failure is not suspected. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Supplemental report 1 incorrectly left the event as a malfunction; however intervention has since been taken.
 
Event Description
A vns pt implanted for depression called and reported that a couple months ago, her psychiatrist changed two parameters on her generator but she did not know what those were. After this, about 3 weeks ago, she started experiencing pain in her neck around the electrode site and up further on her neck. The pt reported that the pain sometimes travels up around the left side of her head and in her jaw and teeth. It was the first time the pt had experienced this pain since implant. The pt had not had any fall or injury preceding the event and it only occurred when her device was on and did not occur during the off times. The pt had used her magnet to temporarily help the pain a couple of times but didn't leave the magnet there for an extended period of time. Their reported pain goes away when the magnet is taped over the device. The pt reported that their depression has gotten worse. It is unk if this is above or below their prevns rate. The pt was seen by a surgeon and they did not feel the vns was causing the pt's pain and that they did not require any kind of surgical revision. They have been referred to see a neurologist. No current device diagnostics have been received to confirm device function. Good faith attempts are underway to investigate the pt's reported events.
 
Event Description
Additional information was received from the patient indicating that the patient is still experiencing pain in her face, however an overall 80% improvement in her depression. The pain stated a couple of months prior to this report. The pain started as tooth pain. The patient then had to tooth removed and the pain was then being felt on the left side of the face radiating up to the skull. The pain reportedly occurs every 5 minutes for 1 minute, and there are no reported issues when disabled with the magnet. This is consistent with the on and off times of the patient's current settings. It was also reported that the patient's pulse width was lowered from 500usec to 250usec; however the date when this was done is unknown. The patient has since been seen by multiple surgeons. A ct scan and x-rays were performed but showed no abnormality. It is unclear if the x-rays will be sent to the manufacturer for review. One surgeon reported that he attempted different settings to determine if the patient still felt pain, and then programmed the patient off to see if she could feel the difference. The patient was able to tell when on versus off and reported intermittent pain in face. The surgeon feels that the patient may feel the stimulation and due to her other psychological issues, she may associate it with pain, even though the diagnostic test was normal. Specific diagnostic results were not provided. The surgeon also recommended that the patient go back to her treating neurologist to adjust settings. The surgeon ordered ct scans and will only re-position (exploratory) as a last option. Currently the patient leaves her device on for half of the day and disables the device with the magnet for the other half. Attempts for additional information have been unsuccessful to date.

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« Reply #74 on: September 08, 2018, 12:58:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/24/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing pain in the ear, neck, and head due to the device twisting and turning, and the patient was referred for surgery due to the pain. It was reported that the patient was evaluated by a surgeon who attempted to manipulate the device and believed it was firmly in place. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

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« Reply #75 on: September 26, 2018, 05:53:59 AM »

Model Number 302-20
Event Date 01/09/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns treating neurologist reported to the manufacturer's consultant that the vns patient was experiencing a 'tightness" in her neck and that over the weekend the patient's range of motion decreased and she could only turn her head about 10% in either direction. There is no pain with stimulation and the range of motion is independent of stimulation. Over the weekend, the patient also experienced a seizure and went to the emergency room. It took the patient a few days to recover. It was reported that the patient does not take her medications on a regular basis and she has a stressful lifestyle. On the friday before the weekend, (b)(6) 2012, the physician increased the patient's settings from an output of 1. 5ma to 1. 75ma. The patient remained in the office for 10-15 minutes following the programming change and reported that she was tolerating the increase. The patient was also observed on friday for her report that she had a clicking noise in her throat, however, no clicking occurred during the clinical visit and it lasted for 45 minutes. The patient reported that she had experienced two episodes of clicking in the front of her throat during stimulation. She stated that the clicking lasted for 30-60 seconds and the episodes were two weeks apart. There was no discomfort associated with this. The patient stated that the previous weekend, she also had a breakthrough seizure on (b)(6) 2012. The patient self-medicated with dilantin which elevated her dilantin level. Previously it had been six weeks since she had a seizure. The patient further stated that her husband is not using the recommended magnet swipe technique for her seizures. The husband was reported to be holding the magnet over the chest during the entire seizure, which disables stimulation, and then moved it away when the seizure stops. This then results in an uncomfortable strong stimulation after the seizure. Additional information has been requested but no further information has been received from the physician to date.
 
Manufacturer Narrative

Event Description
Further reports regarding this patient's increased seizures with the suspect generator were received and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.
 
Event Description
Additional information was received on (b)(6) 2012 when the patient stated that her throat hurt with stimulation the night before but not as much in this morning. The patient said the magnet swipes help with seizures, but sometimes her husband swipes the magnet when she is coming out of a seizure and she can't tell him not to, and then it hurts. The patient was seen by the neurologist on (b)(6) 2012 and the vns device was interrogated and system diagnostics were performed which showed results within normal limits; lead impedance=ok/dcdc=2. The patient's generator was programmed to output=1. 5ma/frequency=30hz/pulse width=250usec/on time=7sec/off time=0. 3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. During the final interrogation, the patient appeared to have an absence seizure then coughed and said she was having pain at the generator site. During the seizure, the magnet had been swiped. The generator was then programmed off, both in normal and magnet mode. The neurologist stated that he is going to leave the generator off until a 3 day video eeg can be done. On (b)(6) 2012, the patient reported that she is 2 days into the ambulatory monitoring and says she has had nocturnal seizures and migraines while monitored, but these are better tolerated without vns; she stated that vns gives her after effects like pain. The patient said she has discomfort above the generator randomly for 20-30 minutes at a time which is the same as before vns was turned off. The patient was seen for a follow-up visit on (b)(6) 2012 and the physician stated that he believes the patient's pain and "tightness" or limited range of movement, are psychiatric in nature and not related to vns. The physician turned the patient's device back on and the patient will not be seen again for another month.
 
Event Description
The patient called and was crying and upset. Frustrated that she cannot tolerate the increases to her device. She is depressed because she has not been able to return to her former level of functioning prior to her re-implant last year. The patient's treating physician is aware of the patient's issues tolerating their stimulation and an appointment was going to be made for the patient to be seen for evaluation.

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« Reply #76 on: September 29, 2018, 04:00:52 AM »

Model Number 300-20
Event Date 04/30/2014
Event Type  Injury   
Event Description
Initially, tt was reported that the patient is feeling a throbbing in the area of the left where the lead is when she turns her head to the right. The patient denied any trauma to the area. It was reported that device diagnostics were within normal limits (dc dc code - 1). It was later reported that the patient experiences a tingling sensation in the left neck when the patient turns her head to the right. The magnet was placed over the device to temporarily disable stimulation and the tingling went away. X-rays were taken and reportedly "looked good". It was later reported that the patient's mother wants the patient to undergo vns replacement. The patient was referred to surgeon for consult. No surgical interventions have been performed to date.
 
Event Description
It was reported that the patient underwent generator and lead replacement on (b)(6) 2015. Pre-operative device diagnostics were within normal limits. The surgeon indicated that there were two small water bubbles in the lead when the neck incision was opened. There was condensation in the generator header where the lead was attached to the generator. Both generator and lead were replaced. The device was confirmed to be programmed off prior to the completion of surgery. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/09/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Additional information was received from the patient¿s treating physician. The believed cause for the patient's report of pain on the left side of the neck when she turns her head to the right has never been clear. The unit has been interrogated numerous times with the patient in different positions, and the unit appeared to be functioning correctly at all times per the interrogation. She has not experienced any pain during any of the times she was having the unit interrogated. The patient¿s surgery was done to relieve discomfort. She continued to complain of twitching sensations. She and her family were also concerned because the vns did not seem to be functioning as it once had. They consistently reported that when the magnet was swiped across the vns unit, it no longer seemed to have any impact on the seizure and she just had to go through the full seizure. The settings prior to surgery were: output current-1. 25 ma, and magnet output current-3. 25 ma analysis of the explanted lead was completed on 02/17/2015. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

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« Reply #77 on: October 01, 2018, 02:16:52 AM »

Model Number 103
Event Date 02/22/2012
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
Analysis of the patient's explanted vns generator has been completed. The generator performed to specifications and no anomalies were found. Review of the generator source code found that the last impedance value taken prior to the generator being disabled was normal at 3029 ohms.
 
Event Description
It was reported by the vns patient that she felt the vns was stimulating erratically and she was experiencing painful stimulation in her neck when she turned her head to the right. The physician took x-rays which were forwarded to the manufacturer for review. Review of the x-rays found no anomalies. No gross lead fractures or sharp angles could be visualized. Vns diagnostics were within normal limits, however no specifics were available. The patient's device was disabled and she stated she was still experiencing the adverse events. No medication or programming changes preceded the onset of the pain. No trauma or manipulation is believed to have occurred. The patient also stated her neck hurts at the electrode site when she lies down. The patient requested to have her device replaced. Follow-up with the site found that the physician is not sure what the events are related to. Surgery to replace the patient's vns is likely.
 
Event Description
Additional information was received indicating that the patient's generator has been replaced. An implant card was received that indicated the reason for replacement was "erratic stim. " the explanted generator has been returned and is currently undergoing analysis.

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« Reply #78 on: October 08, 2018, 01:31:00 PM »

Event Date 03/20/2012
Event Type  Injury   
Event Description
Reporter indicated a patient had the vns lead "extended" surgically due to experiencing painful stimulation in the face when the head was turned. The reporter declined to provide any additional information at the time of the initial report, and all attempts to the reporter for additional information have been unsuccessful to date.

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« Reply #79 on: October 09, 2018, 12:38:54 PM »

Model Number 302-20
Event Date 07/29/2011
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the correct event date for the high lead impedance is provided. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated the painful stimulation was felt to be related to a "short-circuit" of the vns. X-rays were taken but were not forwarded to the manufacturer. The high lead impedance was first noted on (b)(6) 2011, and the patient had reported feeling electrical shock sensations in her neck when turning her head to the left for the previous month. Vns diagnostics were last within normal limits in (b)(6) 2010. Analysis of the explanted vns generator and lead was completed. No anomalies were identified with the vns generator and the generator performed per specifications. During the lead visual analysis of the returned 35mm lead portion, the green (-) electrode quadfilar coil appeared to be broken approximately 12mm from the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged and pitted which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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 portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
Reporter indicated a patient was noted to have high lead impedance with vns diagnostics in (b)(6) 2011. The patient was also experiencing painful vns stimulation in her shoulder. The vns was disabled, but no other interventions were done as the patient was pregnant at the time. The patient does have a history of falling with her seizures. The patient delivered her baby in (b)(6) 2012 and surgical replacement of the vns lead and generator occurred on (b)(6) 2012. Diagnostics with the new generator and resident lead still indicated high lead impedance, ruling out a lead pin issue and making a lead fracture more likely. Diagnostics with the new lead and new generator were within normal limits. However, during explant of the resident lead, the jugular vein was nicked which required a vascular surgeon to assist with the repair. The new vns system was left disabled. The explanted generator and lead have been returned and are pending analysis. Attempts for further information are in progress.

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« Reply #80 on: October 15, 2018, 11:49:01 AM »

Model Number 300-20
Event Date 04/16/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The company representative reported that the surgeon pulled the lead when installing the new generator, making the lead taut. After closing the patient and waking her, the patient was in pain as a result of the tautness when she turned her head to the right. The surgeon opted to take the patient back in to surgery to correct. Surgeon used electrocautery and cut the lead at that time. The surgeon noticed that he had cut the lead immediately and damage was visible. The surgeon noted that no injury to the vagus nerve was observed. He did not opt to perform full revision. Therefore, the patient's device was disabled and was never programmed. The patient was referred to a different facility for full revision. The physician noted that patient was a little hoarse following surgery which is believed to be related to surgery, but there was no paralysis believed to be present. No serious injuries occurred, and no interventions were taken to preclude a serious injury. The hospital discards products in surgery, so attempts for product return of the explanted generator on (b)(6) 2012, were unsuccessful. The patient had generator and lead replacement surgery on (b)(6) 2012. Pre-op system diagnostics indicated high lead impedance. The surgeon displayed the x-ray in the operating room, and a lead discontinuity was visible near the generator area. Two system diagnostics on the newly residing generator (one out-of-pocket and one in-pocket) indicated okay results. The field clinical engineer confirmed that the generator was replaced for compatibility to the single pin lead. The explanted generator and lead on (b)(6) 2012, were received by the manufacturer. Product analysis for the generator and lead was completed. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis of the lead identified a coil discontinuity in the positive coil. Scanning electron microscopy images of the positive coil suspected broken ends show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in both coil ends. The suspected coil break is located at approximately 8. 3cm from the end of the connector bifurcation. This was most likely caused during the implant/explant procedure, as reported by the company representative who attended the surgery. Also, the positive coil has what appears to be wear (flat surfaces) in the vicinity of coil discontinuity. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred on the coil in the vicinity of the identified flat surfaces. The outer silicone tubing has what appears to be an imprint at approximately 8. 3 cm from the end of the connector bifurcation. The exact reason for this imprint is unknown. Also, the inner silicone tubing of the positive coil has what appears to be tearing at this location. The unmarked connector pin has what appears to be pitting in the vicinity of the setscrew marks. The inner silicone tubing of the positive coil is abraded open at approximately 8. 1-8. 4 cm from the end of the connector bifurcation. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies (besides an abraded inner tubing opening) were identified in the returned lead portion.

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« Reply #81 on: November 06, 2018, 07:45:30 AM »

Model Number 102
Event Date 07/01/2012
Event Type  Injury   
Event Description
Analysis of the generator was completed. 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 generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
Clinic notes dated (b)(6) 2012 were received for the patient's prophylactic generator replacement, which indicated that the patient had no seizures since last seen in (b)(6) 2012. However, patient "has noted some intermittent little sharp stabbing pains sometimes associated with movement, not clearly associated with discharge of the unit, which is still going off, but she is 8 years out this month for placement and may need a replacement of her generator. " interrogation was performed on this date which confirmed the vns settings were unchanged from (b)(6) 2012, and device diagnostics showed no changes and were within normal limits. Device showed it was not at end of service. The patient was referred for surgical consult to assess whether she needed a prophylactic replacement generator and leads, as it was "that time. " the physician also noted that there are "possible adhesions in the vns generator pocket causing position related movement pain in the generator versus possible subclinical premature discharge of the unit because of end of service," as it has been implanted for eight years. Attempts for additional information from the treating physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
 
Manufacturer Narrative

Event Description
A letter was received from the treating physician in response to the follow-up on (b)(6) 2013. In relation to the patient's pain, she provided the physician a history of pain developing approximately 6 months prior to january. She describes it as being located in the left chest, predominantly around and below the generator device with a lesser degree of discomfort within the neck region of the attachment to the vagal nerve and less so within the left temporal parietal region of the head. The patient initially had reported some transient discomfort on the right side, but that has dissipated and is now predominantly in the left side. The patient has had plans for evaluation for replacement of the generator based on the timeframe involved for the placement of the generator, but has also undergone chest x-ray and lead integrity x-rays, the results of which are still pending. However, she is undergoing plans for pre-operative evaluation for replacement. Per the physician, these plans of course were not done to preclude a serious injury, as he doubts that there would be unless her seizures increase tremendously, which they have thus not done. For patient comfort, he believes these plans were necessary. The outcome of many of these tests for the patient's symptomatology are pending. The physician does not believe that there were any programming or medication changes that preceded the onset of pain based his my records, and there was no known manipulation or trauma that occurred that both the patient and physician are aware of that would contribute to her pain. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the date of the event and therefore the patient's age at the time of the event incorrectly based on the additional information received from the physician. Date of event, corrected data: the initial report inadvertently reported the date of the event incorrectly based on the additional information received from the physician.
 
Event Description
The patient had prophylactic generator replacement on (b)(6) 2013. The explanted device was received by the manufacturer on (b)(6) 2013, however product analysis has not been completed to date. The return product form confirmed the reason for replacement and showed eri=no.

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« Reply #82 on: November 09, 2018, 02:26:03 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/10/2018
Event Type  Malfunction   
Event Description
It was reported that upon interrogation this patient's device was showing near end of services (neos) = yes and high impedance. The patient has been referred for surgery. Clinic notes were received for this patient's replacement due to high impedance which indicated that the patient is showing decreased battery life and abnormal lead impedance as well as recurrent seizures. The patient reports electrical pain with head turning left. And therefore the vns was reprogramed to reduce pulse width. The patient also feels shortness of breath intermittently every couple days with the vns going off. 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=7933577
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« Reply #83 on: November 17, 2018, 04:49:10 AM »

Model Number 102
Event Date 10/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient underwent surgery in (b)(6) 2013 to check the state of the vns system. No anomalies were found. The generator was moved to a different place inside the chest pocket. The generator was turned back on 10 days after the surgery, and it was noted that the patient did withstand an output current up to 1ma, but 1. 50ma appeared to cause painful stimulation (1. 25ma was not tested). The patient stated that painful stimulation seems to be increased or triggered in certain positions of the patient, especially when he keeps his head bent to one or other side. Review of programming history shows that the device was disabled on (b)(6) 2012 and programmed on (b)(6) 2013. Painful stimulation was initially reported in (b)(6) 2012; however, the event began in (b)(6) 2012 when the output current was at 1. 25 ma. System diagnostics showed that the lead impedance was within normal ranges, with dcdc = 3, and normal mode diagnostics returned impedance within normal ranges too, with dcdc = 5. The generator was disabled. Further information was received stating that the pain started in (b)(6) 2012. No causal or contributory programming or medication changes preceded the beginning of the painful stimulation. No trauma was noted, though the patient reported that the first painful shocks occurred after a physical effort (he raised something heavy). No other interventions were planned at that time. X-rays were provided for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No acute angles or clear breaks were found in the parts of the lead that were visible. Attempts to obtain further information were unsuccessful.

Manufacturer Narrative
Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075477
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dennis100
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« Reply #84 on: November 26, 2018, 04:43:52 AM »

Model Number 102
Event Date 04/03/2013
Event Type  Injury   
Manufacturer Narrative
Initial report inadvertently listed wrong event date.

Event Description
It was reported that the patient's seizures have worsened and that the patient's symptoms such as control of head/neck movement, and drooling have been worsening. The patient underwent surgery on (b)(6) 2013 where the vns generator was replaced. Attempts to return the product to the manufacturer for product analysis are underway. Attempts to contact the physician regarding the events have been unsuccessful to date. A battery life calculation was performed using the available programming history and resulted in 3. 41 years until end of service.

Event Description
New information was received from the physician¿s office stating that the increased seizures were noted on (b)(6) 2013, and the reason of the increased seizures was that the vns generator needed to be replaced. On (b)(6) 2013 the patient¿s seizures became better and the seizures were back to normal. The patient¿s muscle weakness and the drooling were not reported to the patient¿s physician. The explanted vns generator will not be returned to the manufacturer due to the site¿s policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3097519
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« Reply #85 on: November 26, 2018, 04:44:42 AM »

Model Number 302-20
Event Date 03/01/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported that the patient had high impedance (7814 ohms). The patient was also experiencing an increase in seizures and burning in the neck. The burning in neck was from (b)(6) 2013 at which time the generator was disabled and the burning resolved. The burning was reported to be worse when the patient turned her head to the right. Additional information was received from the physician. It is unclear when the increase in seizures started but it started with many generalized seizures which the patient not had gtc for many years. The physician indicated that the increase in seizures and neck pain were related to vns but did not provide the specific relationship but may be related to the high impedance. The increase in seizures was above pre-vns baseline and all seizure types that the patient has increased. There were no causal or contributory programming changes, medication changes or other external factor that preceded the onset of the increase in seizures or pain. There was no manipulation or trauma the contributed to the high impedance. For the increase in seizures the patient had onfi dosage increased and lead and generator replaced. For the pain the vns was turned off prior to replacement. The pain in the neck was not always occurring with stimulation. The patient had x-rays taken however they have not been provided to the manufacturer for review. The office does not know if the x-rays will be sent in as there was no indication in the notes that they will be sent to us and this office no longer had the x-rays. The patient had a generator and lead replacement. Good faith attempts for product return have been unsuccessful to date. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3089414
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« Reply #86 on: December 03, 2018, 04:24:20 AM »

Model Number 102
Event Date 04/23/2013
Event Type  Injury   
Event Description
The physician provided the operation notes from the (b)(6) 2006 vns implant to provide information on the sutures used. The notes state: "the lead was connected to the battery device. Lead tests were then performed showing the lead to be adequate both externally and after the device had been implanted subcutaneously. Both incisions were then approximated using vicryl for the subcutaneous tissues and staples for the skin. ".

Event Description
It was reported that the patient underwent surgery at which time the generator was confirmed to be programmed off and not at end of service. A new generator was placed and it was reported that the existing lead check out "ok" and was not replaced. It was reported that the new generator was programmed on and is "functioning". The implant card confirmed that the patient underwent generator replacement. The lead impedance was not marked. The generator has not been received by manufacturer for analysis.

Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the vns patient has been experiencing a shocking sensation in her neck when she turns her head a certain way since (b)(6) 2013. No causal or contributory programming or medication changed preceded the onset of the event and no patient manipulation or trauma occurred. The physician stated the normal and system diagnostic results were ¿abnormal¿. The physician also stated that there has been no settings change since (b)(6) 2009. The patient¿s vns was turned off due to the shocking sensation. The physician mentions that the cause of the shocking sensation was a ¿faulty cable, stressed from excessive movement of the battery after the patient¿s recent weight loss¿. The patient described her generator as flipping inside her chest at night that started prior to (b)(6) 2013 and stated that she has lost 80 lbs since her vns implant. It was mentioned that the patient¿s generator is going to be replaced as an intervention. The physician stated that no direct patient manipulation or trauma occurred that is believed to have caused/contributed to the device flipping but that the patient had undergone bariatric surgery, resulting in substantial weight loss, and thereby resulting in the battery pack becoming loose and highly mobile underneath the skin. The physician again mentioned that ¿this subsequently stressed the cable¿. The patient also mentions that starting (b)(6) 2013 the patient felt her device was constantly stimulating and not cycling off even when she held the magnet over the device. The physician stated that the patient¿s magnet was not secured correctly over the device when the patient came into the office. The physician was able to disable the patient¿s device in the office and device diagnostics performed on (b)(6) 2013 were within normal limits. The patient was noted to have a mild cough/clearing of throat approximately every 5-10 seconds that occurred due to stimulation. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Incorrect date of birth was inadvertantly listed on the initial mdr.

Manufacturer Narrative
Brand name / type of device / name / model # / serial # / lot# / expiration date / device manufacture date; corrected data: the information provided in supplemental manufacturer report #03 indicated that the suspect device was the generator; however, the suspect device was inadvertently not updated in the report.

Event Description
Additional information was received stating that the generator was near end of service. The explanted generator was returned to the manufacturer for analysis. The as-received generator was not at end of service but the elective replacement indicator (eri) was set. The as-received output current was programmed to 0ma so it wouldn't be expected that the battery voltage continued to deplete after surgery. The generator septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3199770
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« Reply #87 on: December 04, 2018, 02:16:16 AM »

Model Number 102
Event Date 03/01/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient had a follow up visit on (b)(6) 2013 and it was decided that the vns device would be turned off for about two months to analyze if there was any change in seizures. If the seizures worsen, revision surgery would be considered. No surgery has been performed to date.

Event Description
Additional information was received indicating that the vns patient¿s device was found to be programmed on during an office visit on (b)(6) 2014. At these settings, the patient was not able to perceive stimulation.

Event Description
Clinic notes dated (b)(6) 2013, indicate the patient has pain in the left neck at the vns region. The patient feels the device is turning on when she touches it and thinks the lead in her neck is touching a muscle, thereby hurting her and sending pain into the ear, sensitivity in gums on jaw, and pain in shoulder and neck muscles. Per the notes, the vns "dysfunctioned" due to high output now with pain and with positional changes. The vns output current was disabled to 0 ma. Follow up was performed to confirm if a device malfunction is suspected; however, no clear answer was provided. The patient will be seen again to determine if a revision or explant surgery should be performed. Surgery has not occurred to date. The patient has reported several instances of pain since (b)(6) 2012; however, no interventions were taken or planned to preclude a serious injury at the time and device malfunction had not been alleged. Below is a summary of the previous allegations made concerning this patient: it was reported on (b)(6) 2012 that a patient could only feel stimulation if her head was turned to the left, and therefore, the patient believes it only works when her head is turned in that direction. The manufacturer¿s representative was present at the appointment and reported that the patient was demanding a full revision. The manufacturer¿s representative performed normal mode and system diagnostics with the patient in multiple positions, and the dcdc value was consistently 4 and 2, respectively. The patient¿s settings on this visit were 2. 5 ma, 25 hz, 250 microseconds, 21 seconds on, 0. 3 minutes off with magnet settings of 2. 75 ma, 250 microseconds, 60 seconds on. The patient reported that the erratic stimulation feeling first began in march when the output current was increased. No recent trauma or accidents were reported. Additional information was received on (b)(6) 2012 from the patient indicating that she awoke that morning with pain around the generator and described it as ¿feeling like a tearing sensation. ¿ the patient reported that she ¿started checking it out¿ and it hurt when she pushed on ¿certain areas. ¿ she also reported that the magnet stimulation did not feel as strong. Later on (b)(6) 2012, the patient reported to the manufacturer¿s representative that the magnet appeared weak. By turning the head to the left, the magnet feels weaker than before. The patient reported that she ¿just had a medium aura,¿ however there was no indication that this was an increase in auras or unusual for the patient. The manufacturer¿s representative attended the patient¿s appointment on (b)(6) 2012. The patient presented with her husband, and she reported that "she woke up one morning and had all this pain at the generator site when she pushed on the generator. " it was clarified that the patient slept on her left side that night on the couch, and she only had such pain the day after she slept on her left side with her left arm up. In addition, she admitted that the pain was due to her pushing on the generator. The patient is reportedly doing really well, and she hasn't had many seizures at all. She complained of voice alterations at the appointment, but the physician indicated that the patient was making her voice change on her own and it did not coincide with stimulation. The patient said it happened with magnet mode stimulation. The patient did seem to have a "jolt" of voice alteration about 60 seconds after she swiped the magnet which did not coincide with her swipe and settings. Diagnostics are fine, and everything is reportedly okay. The physician believes that the patient wants attention, and so she is asking for a full revision. However, she was not referred for surgery at this time. The physician said that he would refer her for surgery if she wants it though, because he likes to please his patients and this patient is persistent. No issues are suspected with the magnet strength, and no follow up was provided on the patient¿s auras. No issues were suspected by the physician. Additional information was received from the patient indicating that she was experiencing pain at the electrode site all day. The patient puts oil on it to alleviate the pain. The patient indicated that if she presses on the lead wire, it hurts even more, and the pain travels into the lower part of the left jaw. The more she turned her head or uses the magnet, the more the site hurts. Additionally, she indicated that she could not turn her head to the left to ¿get the strongest results¿ during vns stimulation and noted swelling in the neck. The patient has reportedly noticed the last couple of days that when she was icing her shoulder (believed to be unrelated) with the ice pack also touching her neck that the swelling had mostly gone down at the electrode site. Follow up with the tc for clarification revealed that the pain at the vns device site is related to operational context as she pushed on the device. The reported events are related to her mental conditions. Her seizures are not above pre-vns seizure frequency. No additional information could be provided as the patient has not been evaluated by the physician. Furthermore, the patient reported in (b)(6) 2013 that she felt the lead had migrated. Follow up with the md revealed that he does not believe lead has moved. Additionally, the ae¿s events that the patient previously reported have all resolved through device setting changes (not to preclude a serious injury). Diagnostics were reported to be within normal limits. The physician started dropping the output current and on time and it is not bothering her as much. The erratic stimulation has since resolved. Additional information was received from the patient on (b)(6) 2013 reporting that for about six months she has been feeling ¿some poking¿ in the electrode area with it hurting at times. During the prior six weeks when the patient went without a seizure, her neck ¿dramatically loosened up. ¿ after using the magnet, her neck tightened up again with pain on the left side of the neck. She has been lifting her head up when lying down to stretch the muscle and loosen up the neck for about the last two months. The patient also indicated that she was still having a problem with the strength feeling stronger when her neck is turned to the left. No additional information has been provided.

Event Description
The patient reported that she believes there may be an issue with her vns, because she was seizure free for eight years and is no longer seizure free. The patient is going to a pain management doctor and specialist for a nerve block, so there is no revision planned at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3312781
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« Reply #88 on: December 16, 2018, 04:06:46 AM »

Model Number 303-20
Event Date 09/12/2016
Event Type  Injury   
Event Description
It was reported on 09/20/2016 that the patient is experiencing a sore throat and has been choking on his food. Other side effects since his implantation surgery include his voice altering. When he drinks he feels like it is going down his left lung. On 09/14/2016 he stated he got a fever of 103. 9. He went to hospital, and found he had aspiration pneumonia and was dehydrated. No fever now. Was taught how to swallow to prevent aspiration but still doesn't help him. He states voice is still scratchy and vibrating. No redness or heat. Full neck swelling is better but incision swallow and lump is still there. He feels like someone is squeezing his esophagus. When trying to speak, he has to push really hard and use a lot of effort to get sound out. He feels like the lead is super tight. It was reported on 10/04/2016 that the patient cannot talk due to his vns surgery. He said his voice is slightly better, best in morning and gets worse throughout the day. Has to push air very hard to get sounds out. He states that he feels that the wire is too tight. If turns head to right and can feel it pulling. Had swallow study - any liquid gets stuck in back of throat and has hard time getting down to stomach. He states sometimes it goes down in lungs and coughs it out. Immediately post op he says he was dehydrated because he couldn't swallow. And he had aspiration pneumonia. He did state a x-ray was done by neurosurgeon who told him it was placed correctly. Patient thinks the surgery damaged one of the nerves coming off the vagus nerve. That he cut too far toward the front of the neck and nicked a nerve. Ent said that he has left vocal cord paralyzed and could take 6mo to 3 years to recover, but may not improve. He also recommended that vns be taken out. The vns is currently not programmed on. No known surgical intervention has occurred to date.

Manufacturer Narrative

Event Description
It was reported that the patient had a few problems since implant. The patient reported that his leads were hurting and causing a shocking pain in the neck area. As a result of the shocking pain, he experienced headaches. He also described a soreness in the neck area that he believed to be due to the shocking vns stimulation and the lead wire being too tight. No further relevant information has been received to date. No known relevant intervention has occurred to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient's surgeon has not seen them since surgery therefore no further information is known about the adverse events. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6028201
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« Reply #89 on: January 07, 2019, 03:30:06 AM »

Model Number 304-20
Event Date 01/05/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device had high lead impedance. Follow up with the physician found that the high lead impedance was observed on (b)(6) 2014. The vns device was programmed off to 0ma following the observation of the high lead impedance. The patient stated that she came into contact with a large magnet over christmas ((b)(6) 2013) and felt strange afterward. The physician will not provide any additional information. Ap and lateral chest and neck x-rays dated (b)(6) 2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. It cannot be assessed if the lead pin is fully inserted as the lead pin is not visible past the connector block. Feed thru wires appear intact. Lead wires appear intact at the connector pins. The lead coils behind the generator before routing upward to the left neck. The portion of lead behind the generator cannot be assessed. The electrodes appear aligned. A strain relief bend is present and appears to be per labeling. No strain relief loop is present. Two tie-downs are visible; however, the tie-downs are not placed per labeling as the first tie-down is not positioned laterally to the anchor tether. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. There are several slivers in the neck area near the electrode; however, these appear to be behind the lead body and not interacting with the lead. No other information has been provided.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The patient reported via facebook comment in 2017 that the vns caused voice alteration and at a higher dose, she felt discomfort in her left neck, left lower tooth and left side of forehead for which her neurologist adjusted dose and time interval in response. She indicated that depending on the slant of her head, she felt that the vns was more intense. In addition, the patient reported brain freezes when she had to take her medications with cold water. She believed it was possible that the vns was going off at that time and causing it. The patient reported during follow-up with company representatives that her vns wasn't changed after high impedance a couple of months after having a cough. She said that she ended up getting pneumonia. The treating neurologist's nurse indicated that while the patient's pneumonia and the high impedance was noted in the patient's clinic notes, she didn't see anything connecting the pneumonia to the high impedance. The programming database and internal data of the patient's generator was reviewed. Per the data, it was found that the patient's generator was re-enabled. Also, it was found that the patient's impedance appeared to be fluctuating from high to normal until (b)(6) 2014, after which there was no further incidents of high impedance. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. 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=3622212
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« Reply #90 on: January 14, 2019, 04:33:12 AM »

Model Number 302-20
Event Date 04/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
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
An implant card was received indicating that the vns patient was experiencing spasms and pain at the generator and lead sites prior to generator replacement surgery on (b)(6) 2014. The generator was replaced due to battery depletion.
 
Event Description
It was reported that the patient has had multiple issues including pain and decreased appetite since the lead was repaired with silicone. The pain in the neck area was intense, and the patient kept ice applied and took medication as a result. The patient had lead replacement surgery on (b)(6) 2014. The patient reported on (b)(6) 2014 improved adverse symptoms and feeling much better since the surgery. The explanted lead is not being returned to the manufacturer for analysis.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon repaired two large tears in the lead with silicone. Since the surgery, the patient was having difficulty turning her neck. When she turned her neck, the patient became nauseous from pain in her throat. The patient was unable to eat due to the nausea and had lost weight. The patient was also experiencing tinnitus with her head turned and having daily headaches. The patient¿s device was recently programmed on. The patient previously had a surgical consult on (b)(6) 2013 for a possible lead migration. The surgeon determined there was no lead migration and stated that the patient¿s device was working well. Diagnostic results showed normal device function as of (b)(6) 2013. Review of the available programming and diagnostic history showed normal diagnostic results through 11/23/2011. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the patient was going to be evaluated by another surgeon for a second opinion. The patient was referred for generator and lead replacement surgery. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator is not available to return to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838722
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« Reply #91 on: January 14, 2019, 04:34:30 AM »

Model Number 302-20
Event Date 04/13/2014
Event Type  Injury   
Event Description
It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370
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« Reply #92 on: January 20, 2019, 03:20:39 AM »

Model Number 302-20
Event Date 05/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for surgery to explant his device due to discomfort and pain from a lead pulling sensation whenever he turned his head. The patient¿s device was disabled in 2011 due to lack of efficacy in treating the patient¿s depression. It was later determined that the patient did not have depression but was suffering from an anxiety disorder. The patient¿s generator and lead were explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Additional information was received stating that the vns patient underwent surgery for patient comfort and not to preclude a serious injury. The patient was a non-responder to vns therapy; therefore, the patient¿s generator was explanted and not replaced. Analysis of the returned generator and lead was completed. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. 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. 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 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 connector pin was inserted into the cavity of a test generator to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. 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. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854239
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« Reply #93 on: January 20, 2019, 03:21:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/26/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received that despite the generator being disabled, the patient continued to experience the previously reported adverse events, specifically pain. It was stated that the paint occurred in the generator area and was associated with left upper extremity pain and some numbness. Because of this, the patient requested both the lead and generator be removed. The physician reportedly advised that the pain the patient was feeling was likely not from vns, but a definitive assessment was not made. No surgical intervention has occurred to date. No additional relevant information has been received.
 
Event Description
Report received that a pain had pain that radiated from her generator site to her neck, face, and right side of her head. This pain was reportedly worse upon exertion but also occurred while sitting. The pain had reportedly occurred for three weeks with a few severe episodes. The patient also reported feeling fatigued. The patient reportedly went to the hospital during one severe painful experience where cardiac work was done. Although the results were negative, there was reportedly some bradycardia. The physician reported that the vns was checked and the settings were "low". The impedance was also reportedly checked and was found to be within normal limits. The physician elected to disable the device but indicated he would refer the patient for follow-up with a surgeon for reevaluation of other etiologies. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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dennis100
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« Reply #94 on: February 12, 2019, 03:23:25 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 #95 on: February 13, 2019, 03:02:24 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 #96 on: February 17, 2019, 06:22:08 AM »

Model Number 302-30
Event Date 01/01/2015
Event Type  Injury   
Event Description
Analysis of the generator was completed on 03/05/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Manufacturer Narrative

Event Description
Initially it was reported that the patient was scheduled for generator and lead replacement for an unknown reason. It was reported that the generator was replaced due to end of service and that it was believed that the patient experienced an increase in seizures, but the pre-vns baseline frequency is unknown. The patient requested to have the lead replaced due to the lead having become more prominent over the last year and pain in the neck when turning head in different directions for 2 weeks prior to surgery. The reason for the protrusion is unknown. Device diagnostics were within normal limits. It was reported that the lead was replaced to preclude a serious injury and for patient comfort. The pain and protrusion resolved following generator and lead replacement surgery. The explanted lead was discarded during surgery. The explanted generator was returned for analysis on 02/10/2015. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570551
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