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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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.

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dennis100
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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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« Last Edit: September 01, 2018, 10:17:20 PM by dennis100 » Logged
dennis100
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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.

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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.

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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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dennis100
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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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dennis100
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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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