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dennis100
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« on: December 26, 2015, 05:55:52 AM »

Model Number 103
Device Problem Device operates differently than expected
Event Date 12/08/2010
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient believed someone had hacked into her device and was experiencing difficulty with stimulation. The patient did not have any seizures since vns. The patient wanted to have her device removed. The patient¿s device was programmed off on 04/02/2014. The neurologist stated that there were no issues with the patient¿s device and that the patient was suffering from some type of psychotic disorder. The patient continued to have issues after her device was programmed off. The neurologist stated that the patient¿s issues were not related to vns attempts for additional relevant information were made but have been unsuccessful to date.

Event Description
Additional information was received from the neurologist stating that vns patient¿s psychosis was related to the event. The patient was having fixed delusions. The patient¿s device was disabled on (b)(6) 2014. The patient was referred for surgery but no know interventions have occurred to date. The patient believed that the police were accessing her device and harassing her.

Event Description
Additional information was received that the patient is able to feel the stimulation on demand when the magnet is swiped across the generator in spite of this device being disabled by the neurologist. It is unknown if the magnet mode stimulation was also disabled. Attempts for additional relevant information were unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient stated that she feels tingling in her heels, legs, and groin when she is around cell phones or technology. She said that the magnet is not turning off her device. She said she sleeps with the magnet taped on and she said that it is still stimulating. She said the device is stimulating erratically. The patient stated that her physician does not entirely believe that she is feeling these things. Per the patient, diagnostics come back fine, and the doctor says the device is working properly. She stated that the device turns on and off at "suspicious intervals". She said that the vns has worked really well for her, and these events began in (b)(6) 2013. The patient¿s new following physician will not provide information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3483718
« Last Edit: February 23, 2016, 02:48:06 AM by dennis100 » Logged
dennis100
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« Reply #1 on: December 27, 2015, 11:32:56 AM »

Model Number 102
Event Date 09/01/2013
Event Type Malfunction
Event Description
On (b)(6) 2014 it was reported that the patient underwent generator replacement due to end of service on (b)(6) 2014. The lead impedance after surgery was noted to be within normal limits. Attempts were made for the return of the explanted product but it has not been received to date.

Event Description
It was reported that device diagnostics show that the generator is not able to deliver the programmed settings. The patient reports tingling in the chest with stimulation. The physician indicated that the that the patient would be referred for x-rays. It is unknown if x-rays will be sent to manufacturer for review. It was reported that the patient has had good results from vns therapy. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Event Description
The vns patient¿s current device settings were provided. A battery life calculation using the available programming history showed approximately 0. 04 years until eri = yes. No known interventions have occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3376824
« Last Edit: February 23, 2016, 02:48:25 AM by dennis100 » Logged
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« Reply #2 on: December 28, 2015, 01:34:46 AM »

Model Number 103
Event Date 03/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient's device was explanted due to the device shocking her. It was unknown if the device was replaced and if the explant was to preclude a serious injury or for patient comfort. Previously it had been reported that the patient was receiving a shocking/tingling sensation from the area of the generator; however, no interventions had been taken or planned at that time. The physician also reported that patient would occasionally receive ¿jolt¿ from area where electrodes are placed. The patient was involved in bicycle crash and received trauma to generator site and the neck in the emergency room. The shocking symptoms began soon after. The system diagnostics were observed as normal, and x-rays did not identify a problem. The device was disabled with the magnet, and the symptoms subsided. Diagnostics were run again in the presence of the physician and tc which returned no indication of lead break. The generator¿s regular stimulation was turned off and magnet stimulation was left on. The physician opted to leave regular stimulation off for the time being and may consider sending patient to surgeon later for replacement to determine if generator damaged. Follow-up showed that the patient was alert and able to recount the details that led to the buzzing/generator jolts on (b)(6) 2013. It was unknown when the event began and no other information was provided. The explanted device was returned and product analysis was performed. It was found 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 139 volts (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccum consumed memory locations revealed that 29. 232% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis performed on the returned lead portions. Note since a portion of the lead body was not returned for analysis a complete evaluation could not be performed on the entire lead products. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3341291
« Last Edit: February 23, 2016, 02:48:43 AM by dennis100 » Logged
dennis100
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« Reply #3 on: December 28, 2015, 10:58:07 AM »

Model Number 103
Event Date 10/17/2013
Event Type Injury
Event Description
On (b)(6) 2013, this vns patient reported that he began having severe swallowing issues two weeks prior and was taken to the hospital. The patient was told that he may have had a stroke as he had numbness on the left side of his face. The patient¿s primary care physician stated that he may need his vns settings adjusted to help with the swallowing issues. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3484481
« Last Edit: February 23, 2016, 02:48:59 AM by dennis100 » Logged
dennis100
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« Reply #4 on: December 28, 2015, 10:58:30 AM »

Model Number 103
Event Date 01/01/2013
Event Type Injury
Event Description
Attempts for relevant information have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2013 were received on (b)(6) 2013. The notes indicated that the patient had canceled an appointment in the past where she was going to follow-up about numbness in the right side of the body. She was not able to attend that appointment because she was in the hospital, and it was believed that the patient had a stroke.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3545751
« Last Edit: February 23, 2016, 02:49:13 AM by dennis100 » Logged
dennis100
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« Reply #5 on: December 29, 2015, 08:21:57 AM »

Model Number 102
Event Date 03/29/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 indicates that the patient was seen for follow up after vns placement performed on (b)(6) 2013. The patient reports hoarseness that waxes and wanes, and is concerned about "feeling the wiring up in the lower neck". The patient had some throat, tongue, and perioral numbness a couple of days ago, but it resolved. The notes also mention that the patient has a past medical history or sleep apnea. Clinic notes dated (b)(6), 2013, indicate that the patient feels like something is "stuck in his throat when the vns is on" and feels like he is choking while eating. The patient went in for revision surgery on (b)(6) 2013, where the lead, and possibly the generator, were revised or repositioned. The devices were not removed and no new devices were implanted. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
Operative notes from the patient¿s (b)(6) 2013 surgery were received. Surgical diagnoses included painful malpositioned vagal nerve stimulator lead. During surgery, robust fibrotic scar tissues was found with suture tie downs dislodged. The note stated that the patient tolerated the initial implant procedure well; however, he began to complain of left neck superficial pain at the site of palpable scar tissue and lead. Initial non-operative management included massage and external repositioning, which were both unsuccessful. X-rays reportedly showed no fracture of the lead. During surgery, the suture tie-downs were noted to have become dislodged. The suture tie-downs were temporarily removed, and the lead was freed as much as possible and then re-secured. The lead course was re-routed to allow gentle curve with strain relief loop recreated and suture tie downs secured to muscular fascia. Scar tissue was revised.

Manufacturer Narrative

Event Description
Operative notes from the patient¿s (b)(6) 2013 implant surgery were received. The procedure was completed with minimal blood loss. No adverse events or complications were noted in the operative report. It was noted that the programming wand was used to interrogate and test the generator and lead, and they tested well.

Event Description
Attempts for additional information did not provide information regarding the events. The only information returned was that the patient did not have a history or diagnosis of osa.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3292790
« Last Edit: February 23, 2016, 02:49:30 AM by dennis100 » Logged
dennis100
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« Reply #6 on: December 31, 2015, 01:23:54 AM »

Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that the 'pt's electrodes were coming off the vagus nerve. " physician notes received by manufacturer indicated that the pt started to "have problems with seizure management" and was experiencing "pain over the left side of face, about the left eye, problems swallowing, problems speaking, and pain with tingling and burning referred into the arms, hands, and now sometimes legs. " "it appears that the lead attached to the left vagal nerve is not well attached and may actually be totally displaced. " the pt was admitted to the hospital, her settings were planned on being changed, and revision surgery planned in an attempt to resolve the pt's issues. Follow-up with the physician indicated that he looked at the pt's x-rays and did not see anything. He also explained that the normal mode diagnostics obtained were ok. Additionally, it was reported that the pt was experiencing headaches and jaw pain. The physician thinks tha it may have something to do with the pt's anatomy that causes the lead to come off. He explained that the pt was extremely psychotic prior to the vns and is now a "completely different person. " revision surgery was performed in 2007. Diagnostics were performed prior to surgery and obtained all normal results with a dcdc code of 3 and eri=no. It was reported that the surgeon found that there was inadequate strain relief "due to improper positioning of the tie downs, the lead was in the shape of a figure 8, and there was a great deal of scar tissue which was never removed from previous surgery that contributed to the pt's events. " the surgeon removed the lead implanted in 2006 and almost all of the scar tissue that was present on the vagus nerve of the pt. There was part of the scar tissue that he did not remove to avoid damage to the vagus nerve. The replacement lead's electrodes were positioned right below the original site of the scar tissue. Diagnostics performed after the surgery obtained normal results.

Manufacturer Narrative
Device malfunction is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861962
« Last Edit: February 23, 2016, 02:49:47 AM by dennis100 » Logged
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« Reply #7 on: January 03, 2016, 03:23:14 AM »

Model Number 102
Event Date 04/04/2013
Event Type Injury
Event Description
On (b)(6) 2013 this vns patient reported that her battery was low and that there had been no indication that it would occur. The patient was waiting to see a surgeon and had been experiencing pain, discomfort, and blackout spells. The patient reported experiencing aura-like sensation, stomach pain, urinary incontinence, tachycardia, and had blacked out once since generator had become depleted. Clinic notes dated (b)(6) 2013 stated patient reported that vns seemed to stop working on (b)(6) 2013. The patient attempted swiping the magnet several times on (b)(6) 2013, which only barely activated the vns device. The patient attempted a swipe on (b)(6) 2013, which produced tingling in the scalp and tachycardia almost instantly. The patient took 2 lorazepams and went to the emergency room. The patient had been prescribed potiga several months prior, but never started as the potential side effects scared the patient and the patient felt that seizures were under control. Additionally, the patient had obtained a bottle of clonazepam several months prior and overdosed on it while also taking regularly prescribed lorazepam on (b)(6) 2013. At the (b)(6) 2013 visit, the vns was successfully interrogated, programmed and diagnostics were performed. The results were provided. The patient was referred for vns replacement surgery. On (b)(6) 2013 the patient reported that she went to the emergency room the night of (b)(6) 2013 because of complications. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3106486
« Last Edit: February 23, 2016, 02:50:03 AM by dennis100 » Logged
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« Reply #8 on: January 04, 2016, 12:56:31 PM »

Model Number 102
Event Date 07/01/2012
Event Type Injury
Event Description
The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.

Event Description
On (b)(6) 2013 clinic notes dated (b)(6) 2013, were received which indicated that the vns patient was admitted to the emergency room on (b)(6) 2013, due to a new seizures type and a new right arm weakness. On the night prior, the patient felt a sudden jerking of her right leg which came up off the bed, followed by her right arm which was shaking as well. The patient stated that it reminded her of a grand mal seizure which she had at age (b)(6), which was unusual for her. The patient's arm became numb, and this was a different seizure, so they wanted to admit the patient after having a head ct which showed abnormalities, nothing acute. The plan was to admit her, and do a video eeg there, thinking that these may be different seizures. It was decided to transfer her, in order to rule out the possibility of stroke, which was doubtful (as this was thought to be a todd's paralysis based on her (b)(6) hmri) but just to make sure there was nothing else going on. By the morning the patient regained her strength in the right hand, suggesting that this was postictal todd's paralysis as suspected. The clinic notes mention that due to the fact that she has been in the er with seizures lately, the last week, and a few other times in the er for other seizures, it may be that she is having a combination of epilespy but also none-epileptic seizures. Clinic notes dated (b)(6) 2013, indicate that the vns battery is at end of service and that before (b)(6) 2012 the patient seizures were picking up, but since (b)(6) 2012, she has had a lot more seizures that are bigger; averaging 2-6 convulsions per month. It was stated that the vns is giving her a little bit of shortness of breath now and then, although she says the symptoms are tolerable. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. A blc was performed which showed 6. 4 years remaining until eri=yes. Good faith attempts for further information from the physician were unsuccessful.

Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 did not indicate that the device will not be explanted due to the hospital's privacy policy. The information has been included in this report.

Event Description
An implant card was received which indicates that the vns device was explanted on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065662
« Last Edit: February 23, 2016, 02:50:18 AM by dennis100 » Logged
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« Reply #9 on: January 04, 2016, 12:56:54 PM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient was experiencing shortness of breath and numbness radiating down their arm along with chest pain and pressure, not in the area of the vns. When patient feels these symptoms, patient "takes some nitro" and the symptoms resolve. Treating neurologist indicated that the reported event was not related to the vns therapy and may be related to the musculoskeletal or cardiac system. The patient was referred to a cardiologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522091
« Last Edit: February 23, 2016, 02:50:35 AM by dennis100 » Logged
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« Reply #10 on: January 07, 2016, 06:51:38 AM »

Model Number 102
Event Date 02/13/2013
Event Type Injury
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the previous night the patient was experiencing a tingling and stinging sensation about the generator and that it is "not working at all". The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. The manufacturer's consultant reported that he checked the patient's device on (b)(6) 2013 since the patient was complaining of a tingling sensation from the generator site when he swipes the magnet, does not occur with normal stimulation. System diagnostics resulted in output=ok/lead impedance=ok/dcdc=2/eri=no. The patient thinks the battery is dying because of the tingling sensation and was referred for a battery replacement. The patient's physician is 4 hours away and since the patient is in prison, has not been able to check the device. Good faith attempts for further information from the surgeon have been unsuccessful. Clinic notes were received dated (b)(6) 2013 which indicate that the patient's leads were functioning fine but he needs a new generator unit. The patient's settings were noted to be output=2ma/frequency=20hz/pulse width=250usec/on time=60sec/magnet output=2. 25ma/magnet on time=60sec/magnet pulse width=500usec.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed generator met specifications prior to distribution.

Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient was being in from prison for a surgical consult as the patient complained of pain from the device. Good faith attempts for further information from the physician were unsuccessful. On (b)(6) 2013 it was reported that the patient is still experiencing pain and the medical assistant was unsure of the nature or location of the pain. The surgeon stated that the prison did not explain whether the patient needed a battery or a battery and lead replacement surgery. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator'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
On (b)(6) 2013 it was reported that the patient underwent prophylactic generator replacement surgery. The explanted generator was returned on (b)(6) 2013 for product analysis. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995994
« Last Edit: February 23, 2016, 02:50:51 AM by dennis100 » Logged
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« Reply #11 on: January 11, 2016, 03:54:39 AM »

Event Date 08/12/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Patient's device was programmed to off in 2002 following an emergency room visit due to difficulty breathing and chest pain. The patient reported that they felt as if they were having a heart attack. The patient complained of numbness and left arm tingling, but not with stimulation. Device diagnostic testing at that time was within normal limits. In august 2002, the patient reported that they were no longer having any pain or numbness with the device still programmed to off. Physician instructed patient to follow-up with their cardiologist to rule out any heart problems, but it is not known whether or not pt has been seen by cardiologist. The patient's device is still programmed to off at this time. Patient was again seen by neurologist in 10/2002 at which time they reported that pt no longer had any numbness or chest discomfort since the vns was programmed to off and there are no plans to program the vns back to on at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426771
« Last Edit: February 23, 2016, 02:51:08 AM by dennis100 » Logged
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« Reply #12 on: January 11, 2016, 07:03:32 AM »

Model Number 103
Event Date 09/27/2011
Event Type Injury
Event Description
Attempts for additional information and product return have been unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent explant due to hypothesia in the left neck and jaw, not related to stimulation. The patient demanded explant due to lack of efficacy and hypothesia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986739
« Last Edit: February 23, 2016, 02:51:24 AM by dennis100 » Logged
dennis100
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« Reply #13 on: January 14, 2016, 12:54:36 PM »

Model Number 102
Event Date 11/02/2012
Event Type Injury
Manufacturer Narrative

Event Description
Product analysis on the generator was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications, and during the product analysis there were no anomalies found with the pulse generator. Pa on the lead was completed on (b)(6) 2013. Note that since the lead's electrode and anchor tether helix were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. However no obvious point of entrance was noted other than the identified tubing openings related to the explant procedure. No discontinuities were identified during the analysis. Other than typical wear and explant related observation, no anomalies were identified in the returned lead portion. A review of available programming history revealed no anomalies. The last available interrogation date was (b)(6) 2011. At that time the generator was enabled and diagnostics were within normal limits. Follow up performed with the treating surgeon was performed however he was unable to provide additional information as he indicated that the patient was evaluated by a neurologist and he was just asked to remove the device. Follow up performed with the last known treating neurologist was performed and it was indicated that they had not seen the patient since (b)(6) 2011. The pain and numbness had not been reported to his office; however he did indicate that the patient had been experiencing hoarseness since (b)(6) 2011. The neurologist did indicate that the patient had fallen off his bike in (b)(6) 2011, but he was unsure if this had contributed to the event. No other information was provided, and attempts to determine a more recent physician have been unsuccessful to date.

Event Description
It was reported that the patient was scheduled to have his vns removed. Clinic notes dated (b)(6) 2012, indicated that the patient was experiencing pain on the left side of his chest and numbness at his incision site. Additionally it was indicated that the patient was never doing "well" until the generator was turned off. Since that time he has not had any more seizures. The patient was referred for generator explant due to the pain. Attempts for additional information are in progress.

Event Description
It was reported on (b)(6) 2012 that the patient had his generator and lead explanted on (b)(6) 2012. The patient was not re-implanted. The explanted products were returned to the manufacturer on (b)(4) 2012 and product analysis is currently in progress and has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862854
« Last Edit: February 23, 2016, 02:51:39 AM by dennis100 » Logged
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« Reply #14 on: January 15, 2016, 10:55:01 AM »

Model Number 102R
Event Date 07/17/2012
Event Type Injury
Event Description
The patient's explanted products have not been returned for analysis after good faith attempts have been made.

Event Description
It was reported to our consultant that a vns patient will be having a battery replacement to a smaller model. The surgery will be performed because when she shakes her left arm it is irritating her she has numbness and tingling down her left arm. Her neurologist believes the implant is next to brachial plexius and she would benefit from re-position (and a smaller demipulse). The patient will be scheduled for surgery in (b)(6) 2013.

Event Description
Additional information was received that the patient went to surgery. They decided to do a complete revision including a prophylactic battery change. The patient reported pain and the decision was made to replace the generator for a smaller generator. They suspected a lead issue related to her initial complaint of pain (neck) and the pocket was already wide for the bigger generator (ie did not want the demipulse to potentially float in the larger pocket) prior to the surgery the device was interrogated and the results were normal and eos=no. However, the surgeon reported a slit in the lead insulation. It was unknown if the slit was made by the surgeon during the surgery or if it was there prior to the surgery. It is unknown if the lead body will be returned for analysis. At this time the generator is being returned.

Event Description
On (b)(6) 2013, it was reported that, since revision, the pain radiating down the patient¿s arm was no longer occurring.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854766
« Last Edit: February 23, 2016, 02:51:56 AM by dennis100 » Logged
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« Reply #15 on: January 17, 2016, 05:48:17 AM »

Model Number 303-30
Event Date 11/01/2012
Event Type Injury
Event Description
Additional information was received when the two 3. 0mm leads that the surgeon had tried to implant in the patient were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
Brand name; corrected data: inadvertently listed "lead model unknown" instead of "lead model 303" on initial report.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was scheduled for an ent evaluation. It was reported that the patient has left vocal cord weakness. Clinic notes dated (b)(6) 2013 were received which indicate that the patient has multiple medical problems including chf, dm, htn, copd, and cva ((b)(6) 2012) who presents to the neurosurgery clinic to be assessed for placement of a vagal nerve stimulator. The patient reported that over the past year, his seizures have progressed in frequency and severity with him now having multiple daily grand mal seizures; when his seizures first occurred, he notes he had one seizure per year. In (b)(6), the patient reports that the surgeon attempted to place a vns on two separate occasions but failed. The patient reports that his vagus nerve was too large which lead to the vns leads breaking each time. The patient has had dense hoarseness since the procedures. Due to the cross reactions between his aeds and cardiac medications, as well as the progressive nature of his seizures, the patient has been urged by his neurologist and cardiologist to have a vns placement attempted once more. Additional clinic notes were received from a visit with another surgeon who indicated that the patient has history of an mri showing evidence of a stroke involving a right artery. The patient is having progressively worsening frequency and severity of seizures refractory to current medications and has 2 failed vns placement attempts. It was stated that an assessment of the patient's vocal cords with an ent is needed as the nerve may be transected or permanently damaged. The patient was seen by an ent specialist on (b)(6) 2013 for evaluation of hoarseness and dysphagia. The patient's quality of voice was raspy and rough and the severity was moderate with a significant impact on voice quality or function. The hoarseness started 11/1/2012 after vns surgery. Associated manifestations are dysphagia, frequent heartburn, sore throat, and tobacco use. The patient feels like foods and liquids don't go down and get stuck, also chokes and coughs at times - all new since surgery. The dysphagia is in the lower throat and the patient feels like food sticks in the throat, has a "lump in throat sensation" and states that even swallowing air can give him a choking sensation. The event is moderately severe. Aggravating factors include swallowing liquids, swallowing saliva only, and swallowing solid food. Associated manifestations include frequent heartburn or indigestion, frequent or chronic hoarseness, frequent or chronic sore throat, neurological problems, and pressure sensation in throat. It was found that there was mobility reduced motion in left cord. The right vocal cord had normal mobility but the left vocal cord was limited. There was good approximation of vocal cord phonation but paresis of left vocal cord was suspected. The patient was referred for a barium swallow to evaluate swallowing issues. The operative notes from the (b)(6) 2012 surgery stated that the vagus nerve was exceptionally large comparative to average anatomy. The 2 mm lead was coiled around the nerve and after coiling it was noticed that the vagus nerve due to the extensive size was being strangulated by the lead placement. Due to the large diameter of the vagus nerve it was felt that the coil could not be kept in contact with the nerve without jeopardizing safety. At that point the procedure was aborted with the incision was copiously irrigated with antibiotic solution. The patient was noted to be morbidly obese. On (b)(6) 2013 it reported that the patient has been going to speech therapy and his voice is improving. The patient started speech therapy about 2 weeks prior and is seen 2 times per week for 2 hours. The patient underwent a modified barium swallow on (b)(6) 2013 and the notes from this visit indicate that the diagnosis was dysphagia and that the patient had left vocal cord weakness. The patient was noted to have a history of coronary heart disease, cva, diabetes, chronic back pain, obesity, and hypertension. The patient had resilient (l) side weakness from cva, gerd. The patient had decreased voice and reports coughing on liquids. Gerd was not observed during evaluation. The patient had aspiration throughout assessment. Oral and pharyneal phases of swallowing are normal. No aspiration with modified barium swallow under fluoroscopy.

Event Description
On (b)(6) 2012 it was reported that the patient was to have an initial implant that day, but the hospital only had 2 mm leads in stock and upon opening up the patient, it was found that he has a big vagus nerve. The surgeon attempted to implant the 2 mm lead but it was constricting the patient's nerve so it was removed and the patient was closed up. The patient was asked to stayed overnight at the hospital to have surgery the next day with a 3 mm lead that was being shipped to the hospital. The patient's wife did not want the patient to stay overnight and wasn't sure she wanted to risk him going through another surgery if the new lead does not fit. On (b)(6) 2012, it was reported that the patient underwent surgery again with a 3 mm lead. The surgeon noted that the vagus nerve was swollen from the previous surgery and due to the patient having a very large neck he was not able to get good enough exposure of the nerve to get the electrodes around the nerve. The patient was closed up again and sent home. The surgeon also noted that the two 3 mm leads he tried to use lost their coil form after trying to coil nerve.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the returned leads. The condition of the returned leads was consistent with conditions that typically exist following manipulation of the leads. The patient stated that his voice is still raspy; he has to yell to be heard. The patient also mentioned that if he has a coughing fit, or laughs in a certain position, he feels like he is being chocked. The surgeon stated that he thinks the patient is too large and the leads will not fit. Although implant surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that a second surgeon told the patient he needed to see an ent (ear, nose, and throat) physician because the nerve might have been severed in the previous surgical attempt. The patient later reported that the second surgeon wants a veeg, ent evaluation, and or notes from the initial surgeon. The patient stated that he is still raspy, struggles to push out air and to be heard, when he touches the skin on the left side of neck to throat area, it feels numb. He also stated that if he laughs real hard or gets excited, he starts choking and may gag while drinking fluid, even on air. The patient stated that he has a history of choking on meat, but he thinks that is because he has no teeth.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744
« Last Edit: February 23, 2016, 02:52:13 AM by dennis100 » Logged
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« Reply #16 on: January 28, 2016, 12:55:39 AM »

Model Number 302-20
Event Date 01/01/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, it was reported that this vns patient was experiencing severe neck pain, facial numbness, and "something about her wires" per the patient's primary care physician. The patient did not currently have a neurologist. The patient had been referred to a surgeon. Attempts for additional information have been unsuccessful. A battery life calculation on (b)(6) 2012, showed negative results to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2710521
« Last Edit: February 23, 2016, 02:52:31 AM by dennis100 » Logged
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« Reply #17 on: January 29, 2016, 01:47:46 PM »

Model Number 103
Event Date 06/22/2012
Event Type Injury
Event Description
It was reported that the patient's generator had migrated, and she was being referred for surgery. The patient was implanted with vns on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that generator had moved under the axillary region causing pain, pressure in the arm, and discomfort. The pain was indicated to be with movement. It was written that the patient would be referred to the surgeon to evaluate vns placement and make changes as needed. Additional information was received from the neurosurgeon after surgery consult revealing that the patient is experiencing numbness to the left arm due to the generator; moving around; the patient had generator replacement surgery on (b)(6) 2012 due to the generator migration. Attempts for product return have been unsuccessful to date. Attempts for additional information from the treating neurologist and implanting physician have been unsuccessful thus far. Additional information was however received on (b)(6) 2012 from the surgeon that performed the generator replacement which revealed that the migration caused the left arm pain and numbness. It was not believed the numbness was related to stimulation. It was not noted in the operative notes if the explanted generator appeared sutured down during generator replacement. However, it was confirmed that the replacement generator was secured to the pectoral muscle. The migration became symptomatic and quite painful before surgery for the patient which is why the patient had surgery. There was no indication of patient manipulation or trauma. No additional information was provided.

Event Description
It was reported that the explanted generator will not be returned for analysis, as the explanting facility requires patient signed release and they will not ask the patient at time of surgery, so therefore, this site will not return to manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662284
« Last Edit: February 23, 2016, 02:52:47 AM by dennis100 » Logged
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« Reply #18 on: February 01, 2016, 01:45:30 AM »

Model Number 102
Event Date 03/01/2012
Event Type Malfunction
Event Description
Lead product analysis was approved on (b)(6) 2012. The lead assembly was returned for analysis. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. A section of the lead assembly was returned for analysis in two pieces. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Inspection of the first portion of the returned lead showed that setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. An abrasion was identified on the connector boot. The lead assembly appears to have been cut at near the end of the connector boot. The lead coils are cut/torn at this location. Inspection of the second portion of the returned lead showed that abrasions most likely caused by the presence of a tie-down were identified. Abrasions were identified on the outer silicone tubing at multiple locations. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the ends of the returned lead portions. Generator pa was approved on (b)(6) 2012. The generator did perform according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "pain"). Testing demonstrated proper device functionality (in both programmed and "on-demand" operational modes) including outputs that meet specifications. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. No performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2012, this vns patient reported that she was hospitalized last month due to incontrollable seizures. The patient reported that problems with device pain began around (b)(6) 2012, and the problems have continued. The patient reported that she had a stroke last month and is unable to move her left arm and left leg. At the time of the report, the patient was receiving physical therapy in her home. An mri was likely to rule out stroke. The patient underwent generator and lead explant on (b)(6) 2012. The electrodes were not removed as they were scarred in. The explanted lead and generator were received on (b)(6) 2012 and are currently undergoing product analysis.

Event Description
On (b)(6) 2012, this vns patient reported that a surgeon would be removing the generator and "snipping" the leads. The patient was unsure if she would be undergoing explant or revision. The patient last met with her neurologist (b)(6) months ago ((b)(6) 2012), at which time the settings were increased. The patient reported that she was having some pain in the neck (like it was poking through), throat tightening, continuous pain in the chest, the generator moving around in her chest when she lays on her side, and tingling in the arm and hands, which causes her to not lift her arm. The patient stated that the issues began one and a half months ago ((b)(6) 2012). The patient stated that the only traumatic incident that occurred just prior to the events was getting her hair washed in the sink at the hair dresser. The patient stated that the positioning may have pulled on her device or positioned her in an awkward way. The patient met with her neurologist's pa (physician's assistant) and was prescribed pain medication to which the patient had an allergic response. The pa referred the patient to the surgeon because her "device was messed up" and was causing these issues. The patient stated that no diagnostics were performed at this time. Attempts for additional information are underway.

Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
The physician did not believe the patient's stroke was related to vns.

Event Description
On (b)(6) 2012, the surgeon and patient reported that following information: the pain in the neck, lead protrusion, and pain in the chest began shortly after the vns surgery. The patient bent down to get something and injured her back. The physician stated that the back pain is not related to the vns, and it was probably a coincidence that it occurred close to the date of surgery. The throat tightening began after the patient's settings were adjusted by a physician in another state. The neurologist adjusted the pulsewidth, and the throat tightening ceased. The tingling in the arms and hand occurs when the patient lies on her left side. The patient reported experiencing feeling this for some time but did not have an exact date. The patient reported lateral migration of the device and stated that it was sitting on her right pectoral muscle. The patient experiences pain from this when moving her left arm. The patient did not know on what this date event began. The pain in the neck, lead protrusion, and pain in the chest were reported to have no relationship to vns. The throat tightening was experienced with stimulation; however, reducing the puslewidth resolved this issue. The tingling was reported due to the lateral device migration interventions for the generator migration included a referral from the surgeon to revise the generator to a newer model and move the generator. No interventions have been planned for the tingling. Aside from the throat tightening due to increased pulsewidth, no causal or contributory programming changes, medication changes, patient manipulation, patient trauma, or physiological changes (i. E. Weight loss) preceded the pain in the neck, lead protrusion, pain in the chest, tingling in the arms and hands, and generator migration. The patient has no history of pain in the neck or chest, throat tightening, or tingling pre-vns. It is unclear if a non-absorbable suture was used to secure the generator fascia during implant as the surgery was performed at another facility. Normal mode and system diagnostics indicated "ok" lead impedance and that the battery was not at end of service. The reference the patient made to the generator being "messed up" was clarified by the surgeon. The surgeon reported that it is likely that the pain she is experiencing is due to device size and migration and is recommending the device be replaced with a 103. The patient's output current was reported to be 0. 75 ma. The surgeon also recommended a revision from a model 102 generator to a model 103 generator and movement of the generator placement. The patient reported that the device was helping and that she did well at settings from her previous physician; however, her current physician has reduced the settings, and, as a result, she is experiencing more seizures. Additional information was received on (b)(6) 2012, that the patient's increase in seizures was below the pre-vns baseline. On (b)(6) 2012, the implanting surgeon confirmed that a non-absorbable suture was used during the initial implant of the device. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597650
« Last Edit: February 23, 2016, 02:53:05 AM by dennis100 » Logged
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« Reply #19 on: February 01, 2016, 09:45:27 AM »

Model Number 103
Event Date 01/27/2012
Event Type Injury
Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.

Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000
« Last Edit: February 23, 2016, 02:53:26 AM by dennis100 » Logged
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« Reply #20 on: February 01, 2016, 09:46:15 AM »

Event Date 04/10/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, follow up with the surgeon revealed that the patient's device was explanted on (b)(6) 2012 and reimplanted on (b)(6) 2012. Cultures were taken and returned positive for infection. The surgeon stated that a granuloma formed in reaction to the silicone tie-down at the lead site. The granuloma was removed, down to the wire. (the date of the granuloma removal was unavailable. ) the site continued to be infected. As a result, the patient's device was explanted. Attempts for product return and additional information have been unsuccessful. The hospital could not locate the explanted devices.

Event Description
On (b)(6), 2012, confirmation was received that the patient underwent surgery on (b)(6), 2012. On (b)(6) 2012, additional information was received that the patient had a full system put in and that the patient had been explanted due to an infection. It is unclear if the patient underwent explant on this date or at a previous surgery. Attempts for product return and additional information are underway.

Event Description
On (b)(6) 2012, a patient's father reported that the patient's lead was extruding in the neck. No trauma or manipulation was reported. Earlier that day, the patient went to his primary care physician at which time the physician pulled the skin back over the site and sewed everything up. The patient's father provided images of the extrusion. Clinic notes were received on (b)(6), 2012 from two of the patient's appointments. (b)(6) 2012 notes reported that the patient had a generalized tonic-clonic seizure (gtcs) on (b)(6), 2012. The gtcs were usually triggered by lack of sleep. The seizure frequency was two per month. (b)(6), 2012 notes reported that the patient received a tingling sensation with stimulation and had about two general tonic-clonic seizures per week. On this occasion, the physician decreased the normal and magnet output currents and the normal pulsewidth. On (b)(6), 2012, the following information was received from the neurologist's office: no causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures or the lead body extrusion. The patient's medication was increased to handle the increase in seizures, but interventions for the lead extrusion were unknown as the patient was referred to a surgeon. The relationship of the increased seizures and lead extrusion to vns is unknown; however, the patient's pulsewidth and output current were decreased. The lead extrusion was first noted on (b)(6), 2012, and no patient manipulation or trauma was known to cause the lead extrusion. Diagnostic results were unknown, as was the pre-vns seizure frequency. No product information (model/serial number) was available. On (b)(6), 2012, information from the surgeon's was also received via phone. This information was also confirmed in clinic notes received on (b)(6), 2012 and dated (b)(6), 2012. It was reported that the patient experienced consistent swelling in the neck a few months prior. The patient was sent for excision of the pyogenic granuloma. No cultures were taken, but the patient was started on clindamycin. The area continues to drain blood and purulent material. At the time of the surgical procedure, the wires were exposed. Since that time, he has felt a shocking sensation in his arm and neck at times. Prior to vns, the patient was experiencing 7-10 grand mal seizures per day which has decreased to approximately one per month. The physician's assessment of the patient was a chronic neck infection after vns placement. The patient was scheduled for explant on (b)(6), 2012 with afb and fungal cultures to follow. It was recommended that the patient have at least two weeks of treatment prior to replacement. Attempts for the return of the explanted products will be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2585568
« Last Edit: February 23, 2016, 02:53:45 AM by dennis100 » Logged
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« Reply #21 on: February 02, 2016, 12:45:35 PM »

Model Number 302-20
Event Date 08/01/2011
Event Type Malfunction
Event Description
On (b)(6) 2012, this vns patient reported that she wanted her generator explanted. She stated that the device had been causing her problems for almost a year. She stated that it is not sitting in the pocket like it should be, and when she lies down, it "floats up" causing discomfort. She stated that she had a mini stroke a few months ago and around the same time, her device was turned off because it was shocking her. She stated that about 4-5 months ago, she was to have her explant scheduled, but it just had not happened. She had spoken with the surgeon in regards to her discomfort and was told that she doesn't have enough tissue in the area where she is implanted which may be the cause for the discomfort. She stated she had not experienced any manipulation or trauma that may have caused either the migration or the shocking sensation. Surgery is still likely, but has not occurred.

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

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

Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated that the events began on (b)(6) 2012. Additional information was received that the problems have been occurring for almost a year. This report is being submitted to correct this information.

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

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

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

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

Manufacturer Narrative

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

Manufacturer Narrative
Review of additional programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2554727
« Last Edit: February 23, 2016, 02:54:03 AM by dennis100 » Logged
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« Reply #22 on: February 03, 2016, 10:22:56 AM »

Model Number 102
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative
Analysis of programming history performed.

Event Description
It was initially reported on (b)(6) 2012, that a vns patient wanted to have her device removed because the battery was dead and when she works out, it causes some pain in her arm. The patient later stated that the vns device never really helped much and was also causing numbness and pain in her arm. Good faith attempts to obtain additional information were unsuccessful. During a review of the patient's programming data available in the in-house programming database, it was noted that the device was programmed off on (b)(6) 2010, however this was the last date of data so it is unknown if the device was programmed back on at a later date or if has remained off. The generator was explanted and not replaced on (b)(6) 2012. The generator will not be returned to the manufacturer for analysis.

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the explanted generator was available for return. The explanted generator was returned to the manufacturer on (b)(4) 2012 and product analysis is underway.

Event Description
Additional information was received on (b)(6) 2012, when analysis of the explanted generator was completed. During the analysis, it was observed that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. In addition, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2535518
« Last Edit: February 23, 2016, 02:54:24 AM by dennis100 » Logged
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« Reply #23 on: February 12, 2016, 09:12:00 AM »

Model Number 302-20
Event Date 02/01/2012
Event Type Malfunction
Event Description
It was reported to the manufacturer that the patient had high impedance on a system diagnostics test performed on (b)(6) 2012. It was indicated that the last acceptable diagnostics for this patient were performed in (b)(6), however no specific results were provided. The physician indicated that there was no trauma or manipulation to the device. The patient's device was disabled, and it was indicated that the patient would be sent for x-rays which would be provided to the manufacturer for review. The x-rays have not yet been received. The physician also noted that the patient had been experiencing headaches with stimulation and also painful stimulation at neck region for about (b)(6) prior to this report of high impedance. The patient was referred for and underwent a full revision on (b)(6) 2012. The explanted products will not be returned as the hospital's policy requires the hospital to keep explanted products for 7 years. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the physician on (b)(6) 2012. An x-ray assessment performed by the site was provided and indicated that no fractures were observed. This however cannot be confirmed as the x-rays have not been sent to the manufacturer. It was indicated that the patient was complaining of headaches, stomach pains, tingling in her neck and chest with vibrating in her voice. She was also complaining of being shocked with headaches. The patient's settings were provided. No additional information was provided.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2482832
« Last Edit: February 23, 2016, 02:54:42 AM by dennis100 » Logged
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« Reply #24 on: February 16, 2016, 03:31:16 AM »

Model Number 103
Event Date 01/21/2012
Event Type Injury
Event Description
It was reported on (b)(6) 2012 that a vns patient had not had her device checked in over a year and went to the er the weekend prior to the report due to an increase in seizures. The patient had 10-12 per day when she would usually only have 2-4 per month. The patient was also experiencing some numbness in her right face, hand and arm. The patient also had a burning feeling on the right side of her brain. The patient currently does not have a physician and has not found one who can check her device therefore all attempts for further information cannot be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438386
« Last Edit: February 23, 2016, 02:55:02 AM by dennis100 » Logged
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« Reply #25 on: February 17, 2016, 01:43:41 AM »

Model Number 304-20
Event Date 11/02/2011
Event Type Injury
Event Description
It was reported that a patient had numbness on her left and right shoulders, arms, and hands. The patient also reported pain in the same area as well as pain in her neck. Per the patient, she never had these problems prior to being implanted with vns. It was believed that the patient may have some nerve damage or a compressed nerve. It was noted that during initial implant surgery, there was excess blood in the chest due to the tunneling process however no main artery or view as affected. Additionally, x-rays were taken by the surgeon during the implant procedure and everything appeared okay. The patient was initially fine after surgery as during follow up appointments a few days after implant, the patient was okay and everything was said to be normal. Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda. This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, cyberonics, or cyberonics; employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any defects or malfunctions. These words are incorporated into the fda 3500a medwatch form by the fda, and cyberonics objects to their use.

Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient is still experiencing the numbness in her left and right arms. The settings were 0. 75/20/250/30/3. Diagnostic results were said to be within normal limits however the specific test results were not provided. The patient was also having difficulty breathing. The plan was to program the patient's device off. Follow up with the physician revealed that the pain (shoulder, arms, hands) was related to vns (stimulation). The patient does have a medical history of shoulder/arm/hand pain prior to being implanted with vns. Systems diagnostics gave acceptable results however the specific test results were not provided. The device was programmed off to prevent a serious injury. The device was programmed off on (b)(6) 2012 and the patient wants the device removed however surgery is not scheduled at this point to his knowledge. He did not have any additional information to provide other than the patient is having anxiety and panic attacks because of the issues with her vns. He could not elaborate further or either of those events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435388
« Last Edit: February 23, 2016, 02:55:19 AM by dennis100 » Logged
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« Reply #26 on: February 18, 2016, 04:40:01 AM »

Model
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« Reply #27 on: February 19, 2016, 04:53:08 AM »

Model Number 102
Event Date 11/21/2006
Event Type Malfunction
Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

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

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

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

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

Manufacturer Narrative

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

Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
« Last Edit: February 23, 2016, 02:55:57 AM by dennis100 » Logged
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« Reply #28 on: February 22, 2016, 04:02:35 AM »

Model Number 302-20
Event Date 12/01/2008
Event Type Malfunction
Manufacturer Narrative

Event Description
Further information from the physician indicates that the tingling in the chest is not believed to be due to vns, but the exact cause is unknown and it is "hard to discern" if it was occurring with stimulation. Per physician, the patient's symptoms do not appear to be consistent. The patient does not have a history of the tingling pre-vns. Per physician, causal or contributory programming or medication changes preceded the onset of the events, but no specifics were given. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. It is unknown whether a nonabsorbable suture was used to secure the generator. The physicians do not feel the issue is with the vns and recommended the patient get a second opinion.

Event Description
Additional information was received that the patient had full revision surgery. The patient's mother felt their was an issue with their device regardless of diagnostic testing being within normal limits therefore a complete revision was performed. The explanting hospital indicated that their explanted products would be returned for analysis.

Event Description
Additional information was received that no diagnostics were run prior to surgery. The device was checked to make sure it was still off but no diagnostics were performed. It had been off since (b)(6) 2008. No diagnostics were performed in the or prior to explant. The generator had migrated and it was hard for the surgeon to find it. The patient was large and he had to do a lot of searching and get a portable x-ray machine to come into room in order to locate the generator. The surgeon did not report seeing a lead break in the or nor anything unusual with the lead. The patient is doing well now since replacement. Nothing was noted or reported in regards to anything seen that would have attributed to their reported pain. Product analysis was completed on the patient's explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on their explanted lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The silicone tubing of the lead has what appears to be a tear opening at approximately 0. 3cm from the end of the connector boot. The positive coil is protruding out from the silicone tubing at this location forming a loop. A broken strand was identified in the positive coil at this location. The inner silicone tubing of the lead coils is covered with what appears to be organic matter at the loop located at the 16-17. 2 cm from the boot. The organic matter was removed to perform proper inspection of the lead coils. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Visual analysis of the broken strand of the positive quadfilar coil shows that a stress-induced fracture has occurred. 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 were identified in the returned lead portion.

Manufacturer Narrative
Device failure caused event but did not cause or contribute to a death. Suspect medical device brand name; corrected data: updated to lead. Corrected data: model/serial number/lot number/expiration date updated to lead. Type of reportable event corrected data ; updated to malfunction. Device manufacture date; corrected data to lead information.

Event Description
It was reported that the patient developed a tingling in her chest in (b)(6) 2008 and the device was turned off. The patient had no pain then. In (b)(6) 2011, the device was turned back on device, but 48 hours later, it was turned off again due to pain. The device has now migrated up and is flipped over according to physician after viewing the x-rays. It was decided to turn the device on to low settings and schedule a follow up visit. The physician is also getting a social worker involved as the patient's behavior seems to be different and change with the presence of the mother in the exam room. According to physician, after reviewing the x-rays, there is no obvious break in the lead and after running a system diagnostics and normal mode, both tests appear to be within normal range. X-rays were sent to manufacturer for review, and no anomalies were noted. The patient was seen for follow-up and wanted the device turned off due to pain. Per reporter, there is a disconnect of where the pain is between the mother and daughter and concern that there may be something else going on with the mother and daughter as the stories don't quite match per physician. Attempts for further information have been unsuccessful to date.

Event Description
The lead only had one broken strand. The broken strand would still allow for current flow through the remaining three filars/strands of the quadfilar coil lead therefore the patient could receive some therapy. It is undetermined how much therapy they would have received.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2385673
« Last Edit: February 23, 2016, 02:56:14 AM by dennis100 » Logged
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« Reply #29 on: February 23, 2016, 02:56:51 AM »

Event Date 11/22/2011
Event Type Malfunction
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
Attempts to obtain additional information have been unsuccessful to date.

Event Description
It was reported that during a follow up visit, high lead impedance was noted on diagnostics. The patient was also reporting numbness in his left arm, however it is unknown if this was related to the high impedance. No trauma was reported. Exact diagnostics were not provided. Attempts for additional information are underway.

Event Description
Follow up with the patient's implanting hospital was performed however they would not provide the patient's implant information as patient authorization is required.

Event Description
Additional information was received on (b)(4) 2012, indicating that the patient underwent revision on (b)(4) 2012. The explanted generator and lead were returned to the manufacturer and product analysis has since been completed. During generator product analysis, results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications and there were no adverse functional, mechanical, or visual issues identified with the returned generator. An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified in the returned portion of the lead. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the high impedance; however as a portion of the lead, including the electrodes, was not returned an evaluation and resulting commentary cannot be made on that portion of the lead.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2382735
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« Reply #30 on: February 24, 2016, 02:40:24 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Initial reporter indicated that after their second implant in 2008 that they had to have another one done. This surgery has not been confirmed to have occurred. The pt reported that their incision failed to heal and they had to go to the emergency department and the doctor healed it. The pt also reported that he got scar tissue built up around the electrodes and a lump at the incision site that was "pinching" the nerve because he had numbness of his left arm. Good faith attempts are being made for additional information about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1440164
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« Reply #31 on: March 03, 2016, 04:25:03 AM »

Model Number 304-20
Event Date 10/05/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received that indicated on a recent visit on (b)(6) 2015 the patient complained that she was feeling tingling in her left neck, left elbow, and left little finger. She had her vns turned off because of these symptoms. The patient requested removal of the vns. Additional clinic notes were received which indicate that the patient feels the vns is not working for her. The patient reported numbness to the arm and feels like it is on fire. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5239410
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« Reply #32 on: March 06, 2016, 04:00:08 AM »

Event Date 07/07/2011
Event Type Malfunction
Event Description
It was reported through a company representative that a physician had contacted him as he could not interrogate a pt's generator. The pt reported still being able to feel a tingle in her throat. The pt was implanted in 2005 and last settings were programmed to 1 ma. At the moment good faith attempts to obtain additional information from the reporting physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2211865
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« Reply #33 on: March 08, 2016, 01:42:10 AM »

Event Date 05/01/2011
Event Type Malfunction
Event Description
It was reported by the pt's father that the pt had been elbowed at the generator site. The pt's generator had been turned off at a previous visit as part of a trial period. After being hit in the chest, the pt claimed that she felt warmth at the generator site and the generator was buzzing and causing tingling up her neck. The mother reportedly held the magnet over the generator site and the pt reported that the buzzing stopped and the heat disappeared as well. They are concerned that the generator may be malfunctioning. Attempts for further info from the site are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2177765
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« Reply #34 on: March 09, 2016, 03:03:04 AM »

Model Number 102
Event Date 04/26/2011
Event Type Injury
Event Description
It was reported that the patient was complaining of a constant tingling/burning sensation around the vns generator. The patient's settings had not been changed since around (b)(6) 2010. The patient would not let the physician disable the device as he was having good efficacy with vns. During a later office visit, the physician disabled the device and the patient reported that the burning/tingling began to dissipate and resolved completely after a few minutes. When the device was turned back on, the sensations began again. No redness or swelling was present around generator. X-rays sent to the manufacturer for review and no anomalies were noted. The patient underwent generator replacement due to the tingling/burning sensation. During surgery, the lead was inspected and no anomalies were seen by surgeon. Further information from physician reveals that the patient had a grand mal seizure prior to report where he banged up his face, which may have contributed to event, but the timeline was unclear. Explanted product was returned to the manufacturer, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155935
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« Reply #35 on: March 10, 2016, 05:17:12 AM »

Model Number 103
Event Date 01/24/2011
Event Type Injury
Event Description
It was reported by the pt's parent that the pt was experiencing breathing problems and numbness of her lips. The pt was seen by her family physician, who said her lungs sounded clear. A x-ray was performed and nothing abnormal was seen at this time. Even use of a rescue inhaler was not beneficial. Diagnostic testing on (b)(6) 2010 revealed normal device function, and the device had just been recently implanted. F/u with the pt's physician indicated that neither the dyspnea nor the numbness was related to vns. The numbness was stated to have first occurred on (b)(6) 2011. Last known settings from (b)(6) 2011 were 0. 75ma, 20 hz, 250microsec, 60 sec, 1. 8 min, 1. 00 ma, 60 sec, 500 micro sec. Later info showed that the pt had undergone more testing by an ent doctor, who saw that the pt's tonsils and adenoids were abnormally large and her left vocal cord was partially paralyzed. He also suggested removal of the adenoids and tonsils. The pt's vns physician, though, did not feel that the adenoid and tonsil issues were related to vns whatsoever, though it was causing the breathing and other issues previously reported. It was not known how the vns affected the paralysis event, though. Attempts for further info have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient¿s device caused the vocal cord paralysis in the patient. The onset of vocal cord paralysis is unknown. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133424
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« Reply #36 on: March 10, 2016, 05:17:47 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133423
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« Reply #37 on: March 10, 2016, 01:07:26 PM »

Model Number 302-20
Event Date 05/03/2011
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by a physician that a pt experienced prickling and tingling sensation in the neck. The treating physician ran diagnostics, which revealed high impedance: 7/limit/high. The neurologist has disabled the device and x-rays were taken. The neurologist suspects that the lead is intact. Additional information from the treating physician indicated that the pt had an increase in seizures that started with the symptoms of the prickling. The last known diagnostics for this pt were of dc dc 3 during the last appointment. No pt trauma or manipulation was reported to have contributed to the event. X-rays were received and analyzed by the manufacturer. Review of x-rays indicated that the generator placement appeared to be normal in the left chest. The filter feedthru wires were intact and the lead pin was fully inserted past the connector blocks. There is a small portion of the lead behind the generator and continuity in that portion of the lead could not be assessed. The electrodes appeared to be properly aligned and placed on the nerve. A strain relief bend and was present and appeared to be per labeling. There are no lead discontinuities or sharp angles observed in the visible portion of the lead body, however, a fracture or microfracture cannot be ruled out. Further information was received from the pt's treating neurologist indicating that the last known good diagnostics were from (b)(6) 2011 and at the moment no surgical interventions are being planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117888
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« Reply #38 on: March 11, 2016, 02:18:24 AM »

Model Number 102
Event Date 05/02/2011
Event Type Injury
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103698
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« Reply #39 on: March 11, 2016, 05:52:08 AM »

Model Number 102
Event Date 04/25/2011
Event Type Injury
Event Description
It was reported that a patient had an episode of intermittent esophageal pain that lasted several hours. The generator's normal mode output was disabled, although the magnet output was left programmed. The patient did complain of pain when using the magnet. Diagnostic testing on (b)(6) 2009 showed the device to be properly functioning. Furthermore, the patient's generator was reported to be able to move around in her chest. Follow-up from the patient's physician at the time revealed that the site would not provide any more information on the subjects. However, at a later date it was indicated that the patient had her generator removed due to "pain" in her axilla region, though a migration event could not be confirmed. Additional information from the patient's surgeon's office stated the patient "complained of pain in the axilla and numbness in the left arm from the generator when lying on her left side". Clinic notes from the neurologist indicated that he did not believe the vns was causing left arm numbness. Analysis on the returned generator showed that the septum was not returned, but no evidence of body fluids were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098578
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« Reply #40 on: March 19, 2016, 01:28:19 AM »

Event Date 12/17/2010
Event Type Injury
Event Description
It was reported by a surgeon that a vns pt's mother indicated the pt experienced cough and could not talk. The surgeon indicated that the pt had been implanted approximately 1-2 weeks prior to the report. The surgeon further stated that the pt was programmed on to received therapy the following day after surgery. The manufacturer told the surgeon that per the manufacturer's labeling, it's recommended not programming the device on for 2 weeks after surgery to allow pt to recover from surgery. The surgeon agreed to contact the treating neurologist on the manufacturer's labeling as he programmed the pt on. Additional information was received from a company representative indicating the pt was experiencing extreme coughing and her voice was gone/having a hard time talking (voice alteration) since her implant on (b)(6) 2010. Additionally, the company representative reported that the treating neurologist had programmed the pt's device off due to the voice issues. In addition, the nurse at the neurologist's office indicated the pt had some numbness under chin above incision. Further information was received from the implanting surgeon indicating the pt was diagnosed with left vocal cord paralysis by an ent who was not familiar with vns therapy. 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=1963278
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« Reply #41 on: March 19, 2016, 01:28:48 AM »

Model Number 304-20
Event Date 12/08/2010
Event Type Injury
Event Description
It was initially reported by a pt that she was experiencing extreme numbness in face & throat two weeks after surgery. It was suspected that pt had nerve damage or nerve swelling and the surgeon believed it most likely would heal on its own. The treating neurologist decided to leave the generator off for additional two weeks to allow the nerve to heal. Further f/u with the neurosurgeon revealed that he saw the pt post-op on (b)(6) 2010 but declined any nerve damage or any adverse events. According to the neurosurgeon, no intervention occurred and he was unaware of any pt manipulation or trauma. The treating neurologist confirmed that pt's numbness in face occurred after vns surgery and no mri was performed. The md believes, the numbness is not related to an organic cause. No diagnostic results were provided by the neurosurgeon or the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956356
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« Reply #42 on: March 26, 2016, 09:21:37 AM »

Model Number 103
Event Date 07/06/2010
Event Type Injury
Manufacturer Narrative
Eval results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that right after surgery, the pt started having jerking and jumping at the left neck area. Her face would also pull to the left as these were painful. Our consultant met the pt and the surgeon in the office the day of surgery and checked the device. It was confirmed that the settings were indeed off. Several system diagnostics were performed which all resulted in normal ok results with impedance around 1700 ohms. You could see the muscle twitching. The pt's surgeon felt it was not related to surgery. The patient went home. Later that day, it was reported that the pt started to feel numb and quickly became numb all over her body including her arms and legs. She also lost her ability to speak which did resolved. The pt's husband was not sure if it may have been a seizure, but she was coherent and understood what he said. She just couldn't respond to him. He called the ambulance and the pt was admitted to hospital. It was felt at the time all the pt events were related to pt stress and not taking her prescribed postoperative pain medications. While in hospital it was reported that the pt's generator area became red, swollen, and painful. The pt had an infection at the generator site and was being treated with antibiotics. Their infection did not resolve. During explant surgery a large amount of pus was noted around the lead and generator. They had their lead and generator explanted related to their infection. Their infection was related to their implant surgery. Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774911
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« Reply #43 on: March 28, 2016, 01:23:11 PM »

Model Number 102
Event Date 12/29/2006
Event Type Injury
Event Description
It was initially reported that the pt was experiencing mild voice alteration with stimulation. It was not believed that a device malfunction was occurring. The painful stimulation that the pt was experiencing was said to "may be due to a massive shoulder operation that the pt had in the near past. " later, it was described that "immediately after the implantation, the pt described a tingling sensation with stimulation. The tingling spread in his left arm and was described as pain with increasing stimulation intensities. The location of stimulation was checked with a plain x-rays, which were not provided to the mfr for review. Subjective and noticeable hoarseness with stimulation was very suggestive of a proper location of the stimulation. The pt did not tolerate the stimulation well and in (b) (6) 2007, experienced pain in the arm with stimulation when 1. 0ma was reached. There was only a quantitative change after reduction of the amplitude or the pulse width during 2008. In the middle of 2009, he noticed involuntary movements of the left arm with each vns-pulse. Therefore, the vns-generator was switched off. On (b) (6) 2010, the vns-stimulator was explanted due to the pain events. At this stage the pt, had clearly visible contractions of the biceps brachii and the deltoid muscle with each stimulation (short test period only). After the operation, he is feeling well again. " the pt was not reimplanted and the device was discarded by the hospital so it would not be returned for product analysis. It is unk if the pt was experiencing a serious injury due to the events or if the device was removed for pt comfort. Review of the programming history available in the mfr's database, showed the last known diagnostics performed were at the time of implant on (b) (6) 2006, which were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662336
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« Reply #44 on: April 01, 2016, 02:40:40 AM »

Model Number 103
Device Problem No Information
Event Date 10/01/2009
Event Type Malfunction
Event Description
Summary: it was reported that a vns pt was experiencing pain and burning sensation on the generator area along with a tingling feeling in the left neck and ear area. Further info from the treating neurologist indicated that the events were occurring during stimulation and the pt had to go to the er because the pain was so bad. No mentioned interventions were taken at the er other than x-rays and ct scan. Further info from the pt indicated that turning the device off using the magnet ameliorated the reported events. Current system diagnostics provided by the neurologist were ok/ok/3400/ 10 years and both normal and magnet diagnostics were ok. Furthermore, the pt reported a choking sensation when doing a magnet swipe which due to the magnet settings running at higher output and also the fact that the on time is 60 seconds rather than 30 seconds. Furthermore, it was also noticed that the pt had voice alteration issues as current settings were 2/15/130/30/3. At the moment, no pt manipulation or trauma has been reported that could have had contributed to the reported events and no device anomalies are noted as the device is functioning as intended. Further recommendations were made from a company representative to have the device turned off and allow rest to the pt and then program the pt back to intended settings. The recommendation was taken by the neurologist and the pt was programmed off. A week later, the pt was reprogrammed to low setting of. 25 ma but the pt could not tolerate the settings. Interventions were to have the generator and lead replaced due to a suspected malfunction with the devices from the neurologist. Additional info was received in the form of clinic notes from the treating neurologist. A review of the received notes revealed the pt was experiencing the following adverse events prior to having vns explanted. Furthermore, a note was made indicating the pt felt discomfort once the device was re-activated by the neurologist in less than 5 minutes and was recommended vns re-implant due current vns device "not right. " info was received from the treating nurse indicating the reported events of burning sensation, pain in the neck, jaw, left ear, and tingling sensations were related to vns stimulation and the neurologist believe something was wrong with the vns device. The pt's generator was explanted due to painful stimulation and at the moment, good faith attempts to obtain product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553673
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« Reply #45 on: April 02, 2016, 03:59:37 AM »

Model Number 302-20
Device Problem High impedance
Event Date 09/01/2009
Event Type Malfunction
Event Description
It was reported to manufacturer that the vns patient's device revealed high lead impedance on both systems and normal mode diagnostic tests that were (b) (6) 2009, which revealed normal device function. There was no patient trauma or manipulation reported to have occurred between (b) (6) and (b) (6) 2009. Clinical notes were received which documented the patient's clinical presentation on the date that the diagnostic test revealed high lead impedance. The physician noted that the patient "has been averaging 3. 6 seizures per month over the past three months. This actually is double and almost triple his seizure frequency over the past nine months. " the physician also noted that the patient "will occasionally get some pain as he has in the past but usually he does not. He usually just notices hoarseness in his voice and perhaps a little tingling in his neck. " the device was programmed off on (b) (6) 2009. Good faith attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date. Revision surgery is likely.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1511693
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« Reply #46 on: April 08, 2016, 01:30:09 AM »

Model Number 105
Event Date 02/24/2016
Event Type Injury
Event Description
The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016. At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri. But it is unknown if the device was disabled prior to mri or if the mri was performed. On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain. The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing. A nurse at the treating hospital requested that a company representative visit to turn the device off. A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode). Diagnostics were performed and reported to be within normal limits. It was unclear if the patient experienced a hear attack. Patient was asked to follow up with the neurologist once discharged. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5508303
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« Reply #47 on: April 08, 2016, 03:12:03 AM »

Model Number 304-20
Event Date 02/18/2016
Event Type Malfunction
Event Description
The surgeon reported that the patient was experiencing pain at the electrode site and numbness on her face. During follow up the neurologist confirmed that the pain and numbness experienced were occurring with stimulation. The patient later went to the emergency room where the on call physician disabled her device. The pain and numbness events resolved when the device was disabled however the patient was still experiencing some discomfort. The neurologist attributed the leftover discomfort to the original pain and numbness event. The patient also reported experiencing an increase in seizures that was reflective of pre-vns levels. This event was related to the lose in therapy that occurred when the device was disabled. The surgeon evaluated the patient after the device was disabled. During this visit he noted high impedance and then referred the patient for lead revision surgery. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498810
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« Reply #48 on: April 19, 2016, 04:16:55 AM »

Model Number 102
Event Date 04/01/2006
Event Type Injury
Event Description
Reporter indicated that they were experiencing numbness and pain in the neck. Later information was received that the pt underwent surgery to have the device removed, but the surgeon's office is unsure of why the device was to be removed. All attempts for more information have been unsuccessful, and thus the relationship between events and vns therapy cannot be determined. Attempts to have the products returned to the manufacturer for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1368996
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« Reply #49 on: April 20, 2016, 04:03:21 AM »

Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction
Event Description
Rptr indicated that pt was experiencing painful stimulation in his jaw, described as "throbbing" and "tingling". Stimulation of the device was stopped with the use of the magnet. Diagnostic testing resulted in high lead impedance. Rptr also indicated that pt had a fall prior to the onset of symptoms. The device was programmed off, and pain resolved. Radiology report noted the presence of a medical device, without definite lead discontinuity observed. Chest x-rays were sent to mfr for review. No obvious lead discontinuities were observed. Lead revision surgery is likely.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=988682
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« Reply #50 on: April 28, 2016, 02:09:57 AM »

Model Number 104
Event Date 01/01/2008
Event Type Injury
Event Description
Rptr indicated that the pt had device explanted due to excessive nausea and vomiting as well as intolerable tingling in throat. Prod has been requested, but has not been returned to mfr to date. All attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1209862
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« Reply #51 on: May 01, 2016, 03:42:40 AM »

Model Number 302-20
Event Date 01/01/2005
Event Type Injury
Event Description
It was reported that after a pt's first vns implantation surgery, she experienced numbness, tingling, and burning sensation, probably representing an infection at her neck site. Followup with the treating surgeon revealed that a mild post op infection had been present. No cultures were taken at the time to confirm the infection. The pt was treated with antibiotics, and the infection disappeared. A review of the device history records showed the device to be sterile prior to distribution.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1040263
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« Reply #52 on: May 02, 2016, 01:13:32 AM »

Model Number 102
Event Date 02/18/2008
Event Type Injury
Event Description
Reporter indicated that a vns patient's generator had migrated, and the patient was experiencing a "tingling sensation" under her left arm. No trauma or patient manipulation was reported. The patient had lost a lot of weight. Generator pocket revision surgery is planned. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1031591
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« Reply #53 on: May 03, 2016, 01:17:50 AM »

Model Number 102
Event Date 11/01/2006
Event Type No Answer Provided
Event Description
Reporter indicated that she was experiencing "shocks" and an increase in migraines. Patient's device was turned off, however, the patient "neck still cramp up when she yawns. " it was reported that the patient had to tilt her head back in order to get the cramp out. In addition, the patient has previously experienced tingling sensations in the neck with device stimulation, voice alteration with stimulation, and protrusion of the lead body at the neck site. Patient indicated that she is considering removing the vns system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1010154
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« Reply #54 on: May 03, 2016, 01:18:29 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Initial reporter indicated that the vns pt was experiencing "tingling sensations" on the "left axilla. " the device was turned off. Reporter indicated that surgery is planned. Good faith attempts are being made to obtain add'l info.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992143
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« Reply #55 on: May 03, 2016, 01:19:02 AM »

Model Number 302-20
Event Date 11/12/2007
Event Type Injury
Event Description
Initial reporter indicated that postoperatively the pt developed hoarseness and numbness near their neck incision. It was additionally reported that the pt was evaluated by an ent surgeon and was diagnosed with left vocal cord paralysis. No interventions have been planned to treat the left vocal cord paralysis. The pt's vns has not been programmed on and they have not had any seizures since their revision surgery. The treating physician is attributing the vocal cord paralysis to the revision surgery. There are no plans to program the vns therapy on at this time. Mdr report number: 1644487-2007-01964 can be referenced for the revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979772
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« Reply #56 on: May 03, 2016, 01:19:43 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
It was reported that the vns patient was experiencing pain at the chest site, and a tingling sensation beginning at the chest site and propagating down the left arm. Additionally, it was reported that the patient was experiencing a "vibration feeling at the generator site. " diagnostic testing following the onset of the reported events revealed normal device function. The treating physician ordered x-rays to assess the device, and it was reported that the implanting surgeon reviewed the x-rays and "did not see anything out of the ordinary. " further information was communicated by the treating physician's office that the belief is that there is an infection present and has recommended removal of the device. Attempts to obtain additional information from the surgeon and treating physician have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989370
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« Reply #57 on: May 03, 2016, 01:20:36 AM »

Model Number 102
Event Date 11/08/2006
Event Type Injury
Event Description
I am a female who was implanted with a fda approved device called a vagus nerve stimulator for treatment resistant depression. I was implanted in 2006, and stimulation began in the same month. I gave my complete medical history to my cyberonics case manager, cyberonics representatives, as well as my psychiatrist, and implanting surgeon. All were informed i had a traumatic brain injury, and am taking seizure medication for seizure disorder from the brain injury. I recently discovered i was not a candidate for vns because i have a brain injury. It states in the physicians manual there is no proof vns is safe or effective for one with a brain injury. Although the device has worked wonders to treat depression, i am clearly not a candidate for vns because i have a brain injury. My device has now been shut off, and will not be turned back on until there is solid evidence it is safe for me to have the device. It is not clear if any further damage has been done at this point. I will have to undergo further diagnostic testing. It has also ben discovered that vns has contributed to my having horrific headaches. The headaches have decreased in intensity since stimulation has stopped. Dose or amount:. 75 miliamps. Dates of use: 2006- 2007. Diagnosis or reason for use: treatment resistant depression. Event abated after use stopped: yes. Event reappeared after reintroduction: yes.

Event Description
This a follow-up report. My vagus nerve stimulator -vns- for treatment resistant depression -trd- was turned off in 2007 because i discovered a pt with a significant brain injury was excluded from testing for the device. Furthermore, as stated in the physicians manual under section 4 labeled "warnings"/"unapproved uses" history of cns injury. Since further evaluation from my doctors, it is clear the vns exasberated my brain injury condition. While my device was on, i was frequently loosing my balance, falling down, had increased left side numbness and tingling, severe headaches, disorientation, nausea/vomiting on a daily basis which lead to a stomach bleed, increased left eye blurred vision and increased left side weakness. Since my device has been turned off, these symptoms have decreased back to what is known to be normal brain injury condition. My device parameter was set at. 75 milliamps because i could not tolerate 1. 0 milliamps. It is clear i should have never been a candidate for vns because of my brain injury. Dose or amount:. 75 milliamps. Frequency: every 5 mins. Route: intracerebral. Date of use: 2006 - 2007. Diagnosis or reason for use: treatment resistant depression. Event abated after use stopped or dose reduced: yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=970441
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« Reply #58 on: May 03, 2016, 11:54:27 PM »

Model Number 101
Event Date 10/25/2007
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was experiencing chest pain when the device was on. Additionally, the physician reported that the patient was seen at the "clinic" and the pain was a level 10, and the patient also experienced "numbness tingling in hands". Three days later the patient continued to experience pain and presented at the emergency room believing it was due to vns therapy. At the emergency room, the patient was advised to tape the magnet over the device. The patient then reported that the magnet fell off and it caused sharp pain. Patient experienced breakthrough seizure from the er visit and medications were added. The following day, the treating physician saw the patient and the device was tested. Both normal and system diagnostics test results revealed normal device function. The device was turned off at the office visit. X-rays were sent to manufacturer for review. There were no obvious anomalies observed that could be contributing to the reported events. Attempts to obtain additional information have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959346
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« Reply #59 on: May 03, 2016, 11:55:18 PM »

Model Number 102
Event Date 09/19/2007
Event Type Injury
Event Description
It was reported that the vns patient began experiencing multiple adverse events which followed an increase in the device settings. The settings were changed from 1. 75m a/30hz/500usec/30sec/1. 8min to 2. 25ma/30hz/500usec/60sec/3min in 7. The patient left the physicians office tolerating the settings. On the way home, the patient began experiencing pain at the generator site during stimulation when the left arm was in a lifted position. Later in the evening, the patient began experiencing muscle twitching under the axilla on the left side with stimulation of the device. The magnet was used to temporarily disable stimulation and the events resolved. The patient was seen by the treating physician the following day and the device was disabled and no diagnostics were performed to assess the functionality of the device. The physician stated that the patients left arm was numb following the events, and the numbness continued while the device was disabled. The physician referred the patient for an mri of the brain to assess for sensory damage. Chest x-rays were taken and sent to manufacturer for review. The connector pin appeared to be fully inserted beyond the connector block and there were no obvious anomalies observed that could have been contributing to the reported events. After further follow up with the physician, it was revealed that the physician believed that "sensory damage" was confirmed after the mri scan but the mri assessment did not indicate any abnormalities. Additionally, the physician attributed all of the events, including the sensory damage, to vns therapy. The patient was scheduled for revision surgery. Prior to surgery, the patient reported to the surgeon that a second opinion was received by a different neurologist, and the patient stated that the physician indicated that "there was spinal damage" and attributed the damage to vns therapy. Attempts to obtain additional information from the second neurologist are underway. During surgery, a system diagnostic test was performed on the device in question and revealed normal function. The chest pocket was opened and the lead pin was verified to be securely connected inside the generator. A second diagnostic test was performed and again revealed normal device function. Per the patients' request prior to surgery, the existing device was removed and a new device was re-implanted. Attempts to obtain the explanted devices are underway, however, the patient has maintained that the "he owns the device". There were no obvious anomalies observed during surgery. The new device was implanted with no complications.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no anomalies were observed that could be contributing to the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=962544
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« Reply #60 on: May 05, 2016, 04:14:29 AM »

Model Number 103
Event Date 01/11/2016
Event Type Injury
Event Description
Further information was received indicating that the patient was seen by the physician on (b)(6) 2016. It was reported that the patient was doing well; the reported events have stopped. It was reported that the physician decided to increase the output current from 0. 75ma to 1ma. The device was tested and system diagnostics returned impedance results within normal limits with 3401 ohms.

Event Description
It was reported that a patient, recently implanted with vns, had side effects: a very trembling voice, sore throat and tingling sensations. It was reported that the device settings (frequency and pulse width) were modified due to those side effects, without success. It was reported that the patient has never had this event prior vns implantation. Programming history of the patient's device was provided to the manufacturer for review. It appears that on (b)(6) 2016, the device was programmed at output current 0. 75ma, pulse width 250-sec, frequency 20hz, on time 30sec and off time 5min. The device system diagnostic test was not performed. Additional information was received from the physician, indicating that the patient was implanted on (b)(6) 2016. The adverse events began when vns was turned on, on the implant date. It was reported that the patient started to have pain when the output current of 1ma was reached. This occurs during the on time, never during the off time. It was also reported that the voice alteration occurs whatever the output current value was, and during only the on time. The patient will be seen in clinic in mid-(b)(6). The impedance will be tested. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No additional information was provided to date.

Manufacturer Narrative
Udi number: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5566664
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« Reply #61 on: May 05, 2016, 04:15:01 AM »

Model Number 106
Event Date 01/22/2016
Event Type Injury
Event Description
On (b)(6) 2016 it was reported that the patient is having shocking from her vns. The vns was reported to be off and lead impedance ok with no recent magnet activations. The patient was referred for vns explant. Previously, on (b)(6) 2016 it was reported that the patient has a tingling sensation at the neck incision site. The patient was seen by the physician and is being considered for possible wound infection. The patient was seen for follow-up and no longer described any tingling or anything that was first reported. The patient reported having consistent burning sensation in the back of her head, and headaches and was concerned that it was being caused by vns. These events were not during stimulation cycle, but more on a consistent basis. All system diagnostics were ran, and came back ok. The physician said that her issues are not related to vns. The physician increased the patient's output current and magnet current by 0. 125 each. On (b)(6) 2016 the physician reported she is still having pain and the only thing that the physician can attribute it to is vns. He has referred patient back to the surgeon, for vns explant. The patient saw the surgeon who also spoke with the neurologist and there has never been a time that there has been any issue showing with vns or diagnostics, and device had been turned off. The patient is still complaining of pain, and even though both physicians think it probably isn't related to vns, and is probably more than likely something different, the surgeon still wants to move forward and have the vns removed at the request of the patient. Apparently this patient has a past history of being a pain management patient. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5567540
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« Reply #62 on: May 07, 2016, 05:12:25 AM »

Model Number 302-20
Event Date 09/17/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that a patient presented with painful stimulation, hyposthesia, and a seizure increase, below pre-vns baseline. Diagnostic tests were performed, resulting in high impedance. Trauma and patient manipulation are not thought to be factors. The patient is likely to undergo revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=928315
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« Reply #63 on: June 06, 2016, 01:17:13 AM »

Event Date 02/15/2011
Event Type Injury
Event Description
I developed brain cancer in my right frontal lobe, found in (b)(6) 2011. The doctor was inserting screws to my skull bone. He tightened one of the screw and it broke so the surgery went longer. I developed an infection with radiation on the area of my previous surgery and the dehisced extending my radiation treatments, these 36 radiation treatments made me very sick. I had to have an emergency surgery to see what was going on in my brain. This surgery revealed that my skull bone was infected and they removed 1/4 or more of my skull and used more screws than they anticipated. I had some kind of infection prior to this and had drains in my head to get excess fluid out of my swollen brain. After this surgery i developed another infection and another hospital stay. Throughout the whole ordeal of dealing with this situation i had six to eight infections, and at least three to four stays in the hospital, some up to 2 weeks. I am not sure what the name of the plates were or what the company was called for these (i have all my notes from this time, i could look through notebooks and files for a day, to find this out). The last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totalled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529168
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« Reply #64 on: June 08, 2016, 01:57:49 AM »

Model Number 106
Event Date 08/11/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
A provider reported that a patient was experiencing numbness under his left jawbone that was believed to be related to the implant procedure. Numbness was experienced before and after vns stimulation was initiated. Lowering vns output did not alleviate the reported numbness. The provider described the numbness as a serious side effect but not a serious injury per se. Lead impedance values via system diagnostics from the date of implant were normal and diagnostics were reported to be normal at subsequent device checks. The patient was to be evaluated by the implanting surgeon. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5164141
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« Reply #65 on: June 09, 2016, 01:08:49 AM »

Model Number 102
Device Problem Device operates differently than expected
Event Date 09/05/2015
Event Type Malfunction
Event Description
The patient had generator replacement on (b)(6) 2015 due to pain. The explanted device was received by the manufacturer. However, analysis has not been completed to date.

Manufacturer Narrative

Event Description
Information was later received that near the time of the initial event, the patient was undergoing a procedure unrelated to vns when an anesthesiologist noticed some spots on her throat and referred her to an ent physician. The patient saw the ent physician sometime near (b)(6) 2015 and noticed that her vocal cords were not opening or closing like they were supposed to. Patient did not have any symptoms from this event. The ent physician did not take any intervention for this and told patient to come back in 6 months for a checkup. Additional relevant information has not been received to-date.

Event Description
It was reported that a patient was experiencing erratic stimulation constantly and tingling pain at neck/clavicle area. Diagnostics were performed and were within normal limits. The patient¿s generator was programmed off, but the pain persisted. The (b)(6) wants the device replaced due to the issue. The device remained programmed off. Per clinic notes from (b)(6) when the patient followed-up with her physician, the patient was seen in the hospital with pain in her neck and throat. The device stimulation caused ¿intense pain¿ in her throat. The patient was unable to speak and felt as if the device was ¿squeezing¿ her throat. After the device was programmed off, the patient reported that the squeezing sensation in her throat became ¿unacceptable stinging in the left neck¿. The magnet was taped to the patient in the hospital to stop the stimulation, but was unsuccessful.

Event Description
Analysis was completed on the generator. 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5118141
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« Reply #66 on: July 04, 2016, 01:06:39 AM »

Model Number 103
Event Date 02/18/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2013 due to high impedance, the vns patient experienced throat tightness and pain that did not occur with stimulation on-times. The patient was unable to tolerate the device settings that were programmed on the previous device. The patient reported that, since replacement, his face would sometimes swell. Diagnostic results showed normal device function. Follow-up revealed that physician attributed these issues to vns. The patient was given anti-inflammatory medications and his device settings were decreased. The physician also indicated that stress may have contributed to the events and that no medication changes preceded the onset of the events additional information was received stating that the patient also began experiencing numbness in the jaw and neck. The patient¿s seizures were noted to be more frequent and longer in duration. The physician attempted to increase the device settings but was unable to due to the patient¿s pain. The physician attributed the increase in seizure frequency and duration to the inability to increase device settings to therapeutic levels. Attempts for additional relevant information have been unsuccessful to date. The high impedance event was reported in manufacturer report #1644487-2013-00524.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789910
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« Reply #67 on: July 08, 2016, 02:20:47 AM »

Model Number 302-20
Event Date 03/10/2015
Event Type Malfunction
Event Description
Additional information was received that the high impedance was first noticed on follow up visit on (b)(6) 2015. Patient was complaining of tingling and itching in the chest around the site of the generator. On initial interrogation, the lead impedance was 9666 ohms. Nurse switched off the stimulator and the itching and discomfort in the chest abated very quickly. The explanted lead only was received and analyzed. During analysis, lead fracture was verified. The outer and inner silicone tubing (positive coil) are punctured open most likely by an electro-cautery tool. Though difficult to state conclusively it is believed that this was most likely caused at explant. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained. Also, one strand of the positive coil shows appearance suggesting that the coil was exposed to some type of electro-cautery tool (most likely at explant). Since the closest electrode to the bifurcation 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 were identified in the returned lead portions.

Manufacturer Narrative

Event Description
It was reported that patient underwent full vns system revision surgery on (b)(6) 2016 due to lead discontinuity and prophylactic replacement for the generator. The explanted products were received by the manufacturer. Analysis of the devices is underway, but it has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5719983
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« Reply #68 on: July 19, 2016, 11:00:57 AM »

Model Number 303-20
Event Date 05/09/2014
Event Type Injury
Event Description
It was reported that the vns patient would at times experience numbness under her chin and hot flushes in her left arm after her device was programmed on during an office visit on (b)(6) 2014. The patient¿s device showed lead impedance within normal limits (impedance value ¿ 2304 ohms) at the time. The patient was seen on (b)(6) 2014 and reported having some pain in her left arm after her device settings were increased. The patient¿s device showed increased lead impedance but still within normal limits (impedance value ¿ 4649, 4622 and 4701 ohms). X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in an abnormal arrangement as they do not align with the spine but rather perpendicular to the spine. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events may be due to the abnormal placement of the electrodes. However, no definitive conclusions can be made. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized but identified abnormal placement of electrodes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899453
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« Reply #69 on: November 28, 2016, 10:38:50 AM »

Model Number 103
Event Date 09/15/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had gone to the er on (b)(6) 2016 complaining of dyspnea, coughing, and a tingling sensation in her face and upper extremities. The physician tested the vns and found high impedance. The vns was programmed off and the patient was referred for surgery. The patient underwent surgery to correct the high impedance observed, on (b)(6) 2016. It was noted that the lead pin was not fully inserted into the generator. The lead pin was reinserted; the impedance was checked both outside and inside the generator pocket. Both sets of diagnostics were within normal limits and there was no need for a replacement of either the lead of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6019996
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« Reply #70 on: November 28, 2016, 10:40:33 AM »

Model Number 102
Event Type Malfunction
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6016651
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« Reply #71 on: January 06, 2017, 08:31:16 AM »

Model Number 304-30
Event Date 06/01/2016
Event Type Malfunction
Event Description
The patient reported experiencing painful stimulation when he turned his head to the left. The painful stimulation progressed to caused the patient to fall to the floor. The patient then had revision surgery on (b)(6) 2016. During surgery there was visible fluid inside the lead casing observed by the surgeon. There were no observed abraded openings or beaks in the lead. The patient's lead was removed. The lead was then discarded by the facility. The physician stated that the patient is a very violent patient and the patient's seizures may have contributed to the event. No high impedance was observed prior to the surgery. No other relevant information has been received.

Event Description
Clinic notes received indicate that the patient had a fall in (b)(6) 2016 and afterwards the patient reported being electrocuted from his vns. It was noted that the tingling and numbness worsened when the patient turned his head to the left. The physician then attempted to lower the patient's settings to mitigate the pain however it did not resolve and the patient was referred to the previously reported surgery. Diagnostics were within normal limits as of (b)(6) 2016.

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial mdr inadvertently checked an outcome; however, there was no reportable adverse event so there was no outcome. Date of event, corrected data: initial mdr inadvertently included a date that did not best represent the time of the event.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6142022
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« Reply #72 on: February 07, 2017, 02:38:33 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type Injury
Manufacturer Narrative

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
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
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.

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.

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
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
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 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
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« Reply #73 on: February 13, 2017, 04:40:04 AM »

Model Number 302-20
Event Date 10/31/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(4) 2012, when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op system diagnostics showed results within normal limits of output=ok/lead impedance=ok/dcdc=2/eri=no. System diagnostics after generator replacement again showed results within normal limits of output=ok/lead impedance=ok/impedance value=2366ohms and output=ok/lead impedance=ok/impedance value=2381ohms. The patient was then programmed to the same settings as prior to surgery; output=1. 5ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. The explanted generator was returned to the manufacturer on (b)(4) 2012, for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
"type of report", corrected data: inadvertently did not check "30-day" on initial report.

Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2011, revealed that the vns has been very helpful with the patient's seizure control but that at the patient's last visit, the patient had feelings of neck discomfort associated with stimulation. The pulse width was lowered which provided relief of the discomfort, but now the patient is experiencing feelings of "insecurity". She perceives that she may be at a greater risk for seizures since the pulse width was lowered and stated that she would like to have the pulse width increased again. Upon increasing the pulse width, the patient experienced a sensation of numbness and tingling down her left arm with stimulation. The pulse width was therefore turned back down to 250 usec and the signal frequency was increased to 25hz. The physician stated that if the patient continues to have these premonition-type feelings the output current may be increased. The physician states that he is concerned that the sensation she is getting upon stimulation are indicative of a lead fracture. He states that x-rays were taken which showed no evidence of a lead discontinuity. The patient's settings were output=1. 5ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The physician further states that if there are any worsening of the patient's symptoms or decreased seizure control they will have a full revision surgery. The physician later stated that the painful stimulation, numbness, and hypoesthesia were first noticed on (b)(6) 2011. No causal or contributory programming or medication changes preceded the events. No patient manipulation or trauma occurred. The patient's most recent settings are output=1. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. The physician stated that she does not have a medical history of numbness or hypoesthesia prior to vns. The patient is having a full revision surgery due to a likely fractured lead according to the physician although no diagnostics were reported that would confirm high impedance. Although surgery is likely, it has not yet occurred.

Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2504493
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« Reply #74 on: February 18, 2017, 03:45:42 AM »

Model Number 302-20
Event Date 03/04/2010
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported to our country rep in (b)(4) by a vns treating physician that they had a pt who was having high lead impedance. Reported that they were having tingling sensation and their dcdc code was 7 back to a 6 and then a 7 again. The pt's vns will be programmed off at their next office visit. No fall or injury was reported prior to their high impedance being attained. Surgery has not been planned at this time. X-rays were received for review but based on the picture clarity, were not able to be assessed fully. There was a suspect area in the neck region and it could not be seen if the lead pin was fully inserted. Further investigation is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2031200
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« Reply #75 on: March 02, 2017, 12:34:24 AM »

Model Number 103
Event Date 11/30/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that an error message was received with diagnostics were run on the pt. A company representative came to the site to troubleshoot the issue. The warning message and result were duplicated by the company representative on her programming system. A generator reset was perform and appeared to correct the issue. The patient's previously programmed parameter cause painful stimulation, hoarseness and tingling which it has not done before. Pt was programmed to lower output current to allow them to adjust to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956837
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« Reply #76 on: March 10, 2017, 06:07:49 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type Injury
Event Description
It was reported by a company representative that this patient underwent repositioning surgery. The surgeon said that the generator had not been secured by a suture and had fallen. Because of this, the patient was experiencing a lead pulling sensation and subsequent pain. The surgeon repositioned it and sutured the generator in place. The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant. The medical assistant reported that the surgery was mainly for patient comfort. She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple. Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month. She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers. Reportedly, the patient's skin was tender, firm and red over the vns generator. The notes reported that there was possible inferior migration of the vns generator. Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort. It indicated that the pain was due to the migration of the generator and traction of the lead in neck. During the surgery the surgeon removed a considerable scar from the initial incision site. The generator was repositioned and device diagnostics were within normal limits. Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge. She was referred to a wound clinic for these issues. The company representative reportedly turned the patient back on after the surgery. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327892
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« Reply #77 on: April 18, 2017, 11:28:40 PM »

Model Number 304-20
Device Problem Fracture
Event Date 02/28/2017
Event Type Malfunction
Event Description
It was reported by a patient that he was experiencing painful stimulation near the generator site and was told by the physician that the lead might be broken. The generator was turned off. Follow-up from the physician provided that diagnostics within normal limits on (b)(6) 2017. The patient had since had a fall and was in the er and had some chiropractic manipulation. The patient has been scheduled for surgical consult. Clinic notes from a visit on (b)(6) 2017 were received which provide the patient experiences discomfort and tingling at the generator site with electrical stimulation, but has not had any seizures. The lead impedance was noted to be high. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434933
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« Reply #78 on: May 02, 2017, 01:51:35 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4341794
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« Reply #79 on: May 02, 2017, 01:52:19 AM »

Model Number 104
Event Date 01/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the patient reports that the vns wires shock her even when the device is off. The patient indicated that she feels like she has lost all use of her left side. It was noted that the patient suffered a fall on (b)(6) 2014, striking the area near the vns. There was no bruising or edema that resulted from the trauma. The patient begun to complain of weakness in her left arm and occasional tingling in her left leg. It was noted that this has not impacted the patient's activity level. The physician programmed the device off on (b)(6) 2014 and x-rays were performed to check for possible damage or movement of the vns caused by the fall. The physician referred the patient to the surgeon because he believed the device has migrated significantly lower than initially placed. The physician reported that he felt the device had migrated some time ago because an x-ray from (b)(6) 2014 showed the device in the same location as the current x-ray. The patient underwent prophylactic generator replacement. Attempts to obtain additional relevant information have been unsuccessful to date.

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« Reply #80 on: May 03, 2017, 12:40:03 AM »

Model Number 103
Event Date 10/20/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received that the patient's device was turned on during (b)(6) 2014 and that the patient is doing well. Patient also experiences pinching sensation in her chest during stimulation and when she lies down. Patient's pain when turning her head was reported to be better and was attributed to be due to patient having a bulging disc.

Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491
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« Reply #81 on: May 04, 2017, 12:47:57 AM »

Model Number 304-20
Event Date 06/06/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and the lead prior to distribution.

Event Description
It was reported that the recently implanted patient¿s neurologist noticed drainage at the patient¿s neck incision and noted that there may be an infection. The patient was advised to call the surgeon. The patient was referred to the emergency room for treatment by the surgeon, and given antibiotics. The neurologist later reported that the infection was mild and he believed it had resolved. No additional relevant information has been received to date.

Event Description
Additional information was received indicating that the patient had facial numbness and swelling that was unrelated to vns stimulation. The patient was referred to the emergency room (er) and treated. Additional information received from the physician indicated that the infection was mild and he believed it was resolved. The physician believed that the reported facial numbness and swelling was a result of the infection as well.

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« Reply #82 on: May 04, 2017, 12:48:53 AM »

Model Number 103
Event Date 07/08/2014
Event Type Injury
Event Description
Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient. The vns device was interrogated and two diagnostic tests were performed which showed normal results. The generator was disabled. At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore. The patient's neurologist says that it could be psychosomatic symptoms. X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6). The device was thus temporarily disabled with magnet mode left enabled. Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled. It was also stated that these patient adverse events are similar to the pain event reported in mfr. Report # 1644487-2011-02585. Additional clinic notes stated that diagnostics were taken again and were within normal limits. The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off. The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues. No known surgical interventions have occurred to date.

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

Event Description
Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description
It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free. The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet. The patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation. The neurologist decreased the patient¿s device settings and the patient was reported to be doing well. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events remains unknown. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3970627
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« Reply #83 on: May 06, 2017, 02:37:47 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 03/16/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a physician that a patient was experiencing painful stimulation. Diagnostics were reportedly okay. The patient currently had placed the magnet over the device to disable stimulation. It was stated the pain began suddenly. From what the patient told him, it was not associated with increase in settings. The plan was to turn off the generator and perform revision surgery. Follow-up from the case manager provided the patient may have had trauma to the neck. Clinic notes were received from a visit on (b)(6) 2017. Within the notes it was provided that the patient has been experiencing shortness of breath and numbness and tingling in the left side of her throat where the leads run through. She feels as if the stimulator is going off all the time. The patient stated she never had similar problems with her previous vns. Diagnostics were provided as ok and battery life was stated as ¿green¿. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6484561
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« Reply #84 on: May 09, 2017, 12:56:01 AM »

Model Number 102
Event Date 05/01/2014
Event Type Injury
Event Description
Additional information was received from the treating physician. He reported that the patient had reached decent settings and requested that his devices get turned off as it was felt to not be helping. The physician reported that the patient was a non-responder. Then, after aed polytherapy failed to improve his seizure control, the physician suggested to turn on his device as it has no role when not active. Once the patient agreed, he displayed a high sensitivity to very low initial stimulations and responded with coughing immediately upon an adjustment that he could not tolerate. Thus, this precipitated the patient¿s requests for a vns removal. The physician reported that this may have represented a psychological response and lack of motivation, but that it was speculative.

Event Description
It was reported on (b)(6) 2014 that the patient reported pain near the generator that persisted mildly even when the device was off for several months. The patient did not believe it improved his seizures, although the surgeon¿s nurse indicated that it may have after it was initially implanted. The patient¿s device was explanted on (b)(6) 2014. The explanted device could not be returned for product analysis as the hospital does not return. Good faith attempts for further information were unsuccessful. It had been reported on (b)(6) 2014 that the patient was on low settings, output=0. 25ma, and felt a pressure in the chest and tingling in the left arm. The physician didn¿t know if the issues were related to the vns.

Manufacturer Narrative

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not report this outcome, as explant occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4191919
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« Reply #85 on: May 17, 2017, 12:35:36 AM »

Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description 
Reporter indicated that pt had their device explanted. The physician indicated that the pt's generator had migrated, and was subsequently causing paresthesia in her left arm. The physician additionally noted that the original placement of her generator was unusual, i. E. Subpectoral muscle, to accommodate the pt's work requirements.
 
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« Reply #86 on: July 07, 2017, 03:18:05 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator. Clinic notes indicated that the patient had had some pain at the generator site since the procedure. She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm. After she turned her generator off, her symptoms improved. She continued to have daily auras and seizures and had the worst period of seizures that she's had in years. For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results. The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation. The issues resolved when the device was turned off, but the patient's seizure rate increased because of this. The surgery was indicated to be due to medical necessity. The patient was replaced due to painful stimulation. Lead impedance issues were not detected prior to the replacement. Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668568
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« Reply #87 on: July 24, 2017, 01:13:53 AM »

Model Number 102
Event Date 03/26/2011
Event Type  Malfunction   
Event Description
A physician reported that a vns pt was experiencing some tingling numbness around her generator site and the pt wanted the device disabled. There had been no reported trauma recently. A company rep was able to visit with the pt and found the pt to have high impedance. Furthermore, the pt occasionally had painful stimulation in her chest, but she now did not want the device to be disabled. The pt did not have a neurologist at the time. The pt underwent a revision surgery. The surgeon opened up the pt's chest site and noticed the setscrew was loose. The surgeon tightened the screw and ran system diagnostic tests and received within normal limit results. The surgeon prophylactically replaced the generator and all diagnostics were again within normal limits. The pt was reported to be "fine" post surgery. Furthermore, an update indicated that the physician felt the pt's tingling numbness was related to the setscrew's looseness. Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092180
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« Reply #88 on: August 04, 2017, 06:14:42 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 06/07/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an episode where he experienced choking, and puking which he explained as a sensation that the generator was continually in magnet mode. He also reported a tingling sensation in his left arm associated with stimulation. X-ray images were reviewed and repealed no relevant information regarding the events. Additional clinic notes were received indicating that the patient reported that he experienced choking and shortness of breath sometimes. He felt scared during sleep. Patient complained of choking, shortness of breath, neck pain radiating left upper extremity. It occurred once in 10-15 minutes. In addition, he complained of pain in left chest and one episode of numbness in the left arm. The normal output current was disabled and magnet mode was left on. The physician notes that there was no abnormality on x-ray. The physician tried lowering the output current and adjusting the frequency, pulse width and duty cycle but the patient could not tolerate. Therefore the normal output current was disabled while leaving the magnet output current on. Patient has no symptoms when the device is disabled. No other contributory or casual events that preceded the reported events. The neurologist plans to refer patient to neurosurgery for a consult in regards to the electrode placement on the nerve. No known surgical interventions have occurred to date.

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« Reply #89 on: August 04, 2017, 08:27:12 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/23/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient was complaining of pain and numbness in the chest wall around the site of the generator. The physician believed that the patient's generator may have "loosened up". Clinic notes indicated that the patient had woken up and began to feel pain at the apex of the generator. He also felt numbness around the generator site that extended to the left side of his lower neck. The physician noted erythema at the left chest and neck. The physician believed that there may have been a dislodgement of the vns generator. The patient's system diagnostics were within normal levels with impedance at 2804 ohms. Approximately 6 months prior, the patient had had a physical alteration with his brother and his chest was hit, and the patient had been worried that the generator was damaged. Impedance was within normal limits. The patient was referred for replacement. On a fax from the physician, it appeared that the patient was referred for surgery to preclude a serious injury and for patient comfort. He indicated that trauma to the vns during the patient's fight with his brother was the believed cause of the migration. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

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« Reply #90 on: September 22, 2017, 01:21:24 AM »

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

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« Reply #91 on: October 02, 2017, 12:31:04 AM »

Model Number 102
Event Date 01/04/2013
Event Type  Injury   
Event Description
The explant hospital reported that the generator is not available to return to the manufacturer for analysis.
 
Event Description
The patient reported that it was known before he moved that he had a broken wire in his neck. The patient reported that he was seen by a neurosurgeon who recommended removal of the vns system after the consultation and review of the patient's previous medical records. It is unknown if device diagnostics were performed at the consultation.
 
Event Description
Further follow-up revealed that the physician described the "generator leakage" as a discomfort sensation like small shocks and itching. The physician reported that he has not seen the patient again for follow-up. It was reported that the patient did not show up for the surgical consult. Surgery may occur in the future; however, it has not occurred to date. It was reported that the patient moved to a different state.
 
Event Description
It was reported that the vns patient was experiencing signs of "generator leakage". The physician reported that the patient was experiencing the same symptoms as the patient experienced in 2011 that the patient underwent generator replacement for (reference mfr. Report # 1644487-2011-01472). The physician indicated that the patient is experiencing a constant tingling and burning sensation around the generator with the new generator. The physician reported that diagnostic testing was "ok". X-rays were taken and sent to device manufacturer for review. No gross lead fractures were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. The patient may be sent for surgical consult; however, no appointments have been scheduled at this time. It is unknown what the physician means by "generator leakage". Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. (b)(4).
 
Event Description
It was reported that the patient underwent vns removal due to pain, burning and discomfort. Good faith attempts for additional, relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the surgeon. It was reported that the device was also explanted (not replaced) due to migration on (b)(6) 2014 for patient comfort. It was unknown when the weight loss and subsequent device migration began. The generator and portion of the lead were removed on (b)(6) 2014. The migration event was also previously reported in mfg report # mfg report #: 1644487-2013-00218, which has since been determined through the new information received to be related to the events in this report.
 
Event Description
The patient has been scheduled for surgical consult. Surgery is likely; however, has not occurred to date.
 
Event Description
It was reported that the patient underwent vns placement surgery on (b)(6) 2015. A new lead and generator were placed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2930499
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« Reply #92 on: October 04, 2017, 01:00:38 AM »

Model Number 103
Event Date 12/10/2012
Event Type  Malfunction   
Event Description
Further review of the operative notes revealed that the vns "device was retested, turned off" during surgery. The company representative followed-up with the surgeon's clinic and reported that the system diagnostic test was performed in surgery without the lead being connected to the generator. Then, the device was programmed on, and a subsequent system diagnostic test was not performed. The company representative reviewed the steps for programming vns devices in the operating room as indicated in labeling. From the available information, it appears that the surgeon performed a system diagnostic test before plugging the generator into the lead. The stored impedance value (from the final electrical test in manufacturing) will not clear until diagnostic testing is performed after connecting the generator and lead. If the device is programmed on prior to diagnostic testing, a high impedance warning message will appear. As there was no testing performed in the operating room, this message was obtained at the patient's first follow-up visit when the device was programmed on and prior to diagnostics. Manufacturer labeling indicates the generator and lead should be connected prior to performing system diagnostics.
 
Manufacturer Narrative

Event Description
The surgeon's office reported that the patient was seen in the neurologist's office on (b)(6) 2012 and presented with high lead impedance (impedance value 62; 10,000 ohms) upon performing diagnostic testing. The patient's device had not yet been turned on since vns initial implant surgery on (b)(6) 2012. The patient was referred back to the surgeon for evaluation. The surgeon's office reported that it was believed that the diagnostics at the time of implant were fine, and the patient did not report any trauma or event that could have precipitated an issue with the lead. The company representative saw the patient on (b)(6) 2012 and interrogated her device and performed system diagnostics. Diagnostics were within normal limits. The impedance value ranged between 2700-2900 ohms. The device was set at 0ma but he programmed her up to perform the test. The patient is difficult to communicate with but she did feel a tingle in her throat. It was clarified that the surgeon did not see the high impedance at time of implant, and the high impedance was only observed on (b)(6) 2012 by the neurologist. Operative notes were received from medical records which indicated that the vns system was tested in during surgery, and there was no note that diagnostics resulted in out of limit results. Attempts for a copy of the surgeon's flashcard have been unsuccessful to date to assess the specific programming completed on the date of surgery and the system diagnostic results following implant.
 
Manufacturer Narrative
Brand name, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the brand name incorrectly as it was initially for the lead. Type of device name, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the brand name incorrectly as it was initially for the lead. Model #, serial #, lot #, expiration date, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the device information incorrectly as it was initially for the lead. Device manufacture date, corrected data: with the new information, the suspect medical device is the generator and therefore the initial report inadvertently reported the manufacturer date incorrectly as it was initially for the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901503
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« Reply #93 on: October 05, 2017, 12:48:46 AM »

Model Number 102
Event Date 02/28/2012
Event Type  Malfunction   
Manufacturer Narrative
(b)(4). Outcomes attributed to adverse event (check all that apply). (b)(4).
 
Event Description
Additional information was received from the physician who stated that the patient experiences a continued four to eight seizures per month. The patient had the seizure in (b)(6) 2012 and the patient reports numbness on (b)(6) 2012 and (b)(6) 2013. However, it was reported that both the increase in seizures and change in seizure pattern were not related to vns. In regards to interventions, the physician stated that there was no injury and that the vns settings were increased on (b)(6) 2013 to 3. 5ma output current. There is no relationship between the increase in seizure frequency to pre-vns baseline levels and the patient does not have multiple seizure types. The increased seizures and change in seizure pattern are not related to vns programming per the physician. Clinic notes dated (b)(6) 2013 state that the patient has had no problems with medications or with vns. The patient's last settings from (b)(6) 2013 were provided as 3. 5ma output current, 20hz signal frequency, 250 micro seconds pulsewidth, 30 seconds on time, 5. 0 minutes off time, 3. 5ma magnet output current, 60 seconds magnet on time, and 500 microseconds magnet pulsewidth. No diagnostic information was provided.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012 the physician's office stated that the patient was scheduled for a visit in march and to follow up after this time. Additional attempts for information have been made; however, they have been unsuccessful. No additional information has been provided.
 
Event Description
Clinic notes dated (b)(6) 2012 state that the patient was seen for follow-up in regards to her intractable generalized tonic-clonic and partial seizures. The patient's medications were listed and it was stated that she quit one medication. It was then noted that the patient has had an increasing number of seizures. Notes dated (b)(6) 2012 indicate that the patient's seizures appear to be increasing in severity, but still only happen a few times a month. However, further in the notes the physician reiterates that the patient has had an increasing number of seizures. It was stated that the patient's medication levels would be checked to determine if any doses should be changed. On (b)(6) 2012, the patient was seen again and it was stated in clinic notes that she was doing good. Per the notes, the patient's seizures continue at about four to eight per month and that the current frequency has been stable over the last several years. The patient continues on the same medications and it is stated that the patient's epilepsy has improved; however, there are still breakthrough seizures. It is unknown what the relationship of these increased seizure events and increased seizure intensity are to vns therapy. It is also unknown what the relationship of the increased frequency is to pre-vns levels. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2963437
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« Reply #94 on: October 06, 2017, 02:06:31 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 07/10/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient is experiencing vocal cord paralysis. The surgeon believes it might be due to the vns strangulating the nerve. Therefore a vns lead revision occurred to determine if nerve strangulation is the cause. It was later reported that the patient began having sharp pains up her left ear to her left suboccipital area when her output current was increased. The patient had numbness of her left neck, left throat and left tongue. This made swallowing difficult. This did not get better with time, and when the output current was turned back down, she did not feel any stimulation unless her head was tilted to the left. It was mentioned that the doctor reported that the patient's nerve was pretty sizeable. The sharp pain that led to the patient's ear and suboccipital area was occurring with stimulation. It was also reported that it was too early to know the cause of painful stimulation, numbness, and vocal cord paralysis. The doctor spent 8 hours in the operating room probing the patient to determine what to do, and decided to cut the anchor tether, and snipped off the end of the positive electrode, and per the doctor, he did not cut any wire. He also believed the negative electrode was kinked and he fixed that. Overall the doctor kept the implanted lead intact with some modifications. The patient's generator was programmed off to allow the nerve to rest after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6878406
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« Reply #95 on: October 07, 2017, 02:02:24 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/26/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing numbness and pain under his arm following vns implant surgery. The patient was initially prescribed pain medication however this did not provide the patient any relief from the pain. It was later reported that the patient's neck and chest incisions from the surgery were not healing well. The patient was then taken to surgery for wound debridement and incision revision. Manufacturing records for the lead and generator were reviewed and confirmed that both devices were sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6853405
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« Reply #96 on: October 13, 2017, 12:34:06 AM »

Model Number 102
Event Date 09/01/2012
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
The patient reported her experience to the fda in medwatch report mw5061274. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totaled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same. " mfr report #1644487-2016-01151 reports the potential infection from replacement surgery on (b)(6) 2013 per the following portion of the patient's report: "i had yet another surgery and infection".

Event Description
On (b)(6) 2013, it was reported that the vns patient had an infection one month after implant that required explant of the vns. The patient was scheduled for re-implantation of the vns on (b)(6) 2013. The patient underwent re-implant surgery on (b)(6) 2013 and the surgeon placed the leads on her right side due to a previous surgery that caused her right vocal cord to be paralyzed. The surgeon stated that after her previous infection on the left with the original implant, he didn't want to take the chance of damaging her left vocal cord. The previous surgery that caused the right vocal cord paralysis was a cervical fusion done may years ago. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead were sterilized prior to distribution. Good faith attempts for further information from the physician have been unsuccessful.

Manufacturer Narrative
The serial number provided for the generator provided on page 4 of the medwatch received indicated "(b)(4)". This is the generator that was implanted in 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119822
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« Reply #97 on: October 16, 2017, 12:34:16 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
Evaluation codes: the initial report inadvertently reported the incorrect conclusion code. There is sufficient information to suggest that the increased seizures is related to normal battery depletion per the physician and is substantiated by the battery life calculation of 0 years remaining.

Event Description
Additional information was received that it is unclear if the patient will move forward with surgery as he is having problem with his prostate. The patient has been continuing to have an increase in seizures and had approximately 15 in a 2 week period. The generator was reported to be depleted.

Event Description
On (b)(6) 2013, it was reported that the patient thinks the vns is not helping but the physician disagrees as the patient¿s seizures are increasing as the ¿device wanes. ¿ clinic notes were previously received dated (b)(4) 2013 which indicated that the patient started experiencing intermittent tingling throughout the body that started 10 days previously. The patient¿s settings were noted to be output= 3. 25ma, magnet output= 3. 5ma, frequency= 20 hz, pulse width= 250usec, on time= 30, off time=1. 8 min. It was stated that the patient¿s battery was dead and the patient would be referred for replacement. The physician later reported that the hypoesthesia was not related to vns. He again reiterated that the patient¿s battery is dead and needs to be replaced. Although surgery is likely, it has not occurred to date. A battery life calculation was performed which showed 0 years remaining until eri=yes. It was later reported on (b)(6) 2013 that the physician has not made any decisions yet as to what he will do. The wife stated that the patient had 2 cps and 1 grand mal seizure within 2 days of each other recently and the wife thinks it¿s because he either missed a medication or because the vns is no longer working. She stated that the battery stopped working about 2-3 months ago. It was reported that the patient is still on hold for surgery and not ready to move forward.

Event Description
An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. Per the implant card, the device could not be interrogated due to end of service. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3229198
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« Reply #98 on: November 13, 2017, 02:58:33 AM »

Model Number 102
Event Type Injury
Event Description
Good faith attempts for additional, relevant information have been unsuccessful to date. The reporter was unable to provide details. She reported she was reporting only off of medical records.

Event Description
Additional information was received from the surgeon that the migration event occurred in relation to events previously reported in mfg report #: 1644487-2013-00218. As a result, this is a duplicate report, and the migration event will be reported on the applicable mfg report #: 1644487-2013-00218.

Manufacturer Narrative

Event Description
It was reported that the patent underwent device replacement due to migration of the device due to weight loss on one occasion. However, the time of the event is unknown. Manufacturer report # 1644487-2011-01472 captured replacement due to tingling and burning around the generator for the patient. Manufacturer report # 1644487-2013-00218 captured explant due to pain related events for the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4555290
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« Reply #99 on: November 16, 2017, 02:52:41 AM »

Model Number 102
Event Date 01/17/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital in late (b)(6) 2013 for numbness and tingling in the left arm and hand. X-rays were taken and it was reported that this may have been a side effect of either seizures or vns. It was reported that device diagnostics were within normal limits. The device was programmed off and the symptoms subsided. The device was programmed back on and the patient was discharged. The patient was seen again in (b)(6) 2013 and the device was said to be functioning as intended. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4573216
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« Reply #100 on: November 21, 2017, 02:55:07 AM »

Model Number 102
Event Date 05/20/2015
Event Type Injury
Event Description
Additional notes from patient's visit to the hospital were received. On 5/20/2015, the patient reported that she will usually have 2 stimulations throughout the day, each lasting for approximately 30 seconds. But on (b)(6) 2015, patient reported a feeling of low frequency stimulation and also reports that she had one episode of higher frequency stimulation that lasted for approximately 2 minutes. No history of similar events in the past were reported. Patient denied any other changes to her health including increased seizure activity until (b)(6) 2015. Since patient had the vns implanted, patient's family felt her seizures were shorter in duration. Device diagnostics were completed on (b)(6) 2015 and lead impedance was ok and device was not near end of service.

Event Description
It was reported that the patient experienced dizziness, tingling sensation in the fingers and increased perception of stimulation recently. Patient¿s dizziness and tingling sensation in the fingers were later reported to be possible partial seizures. Patient had gone to the er as she does not have a neurologist and the er nurse was informed about the magnet uses to disable the device. Additional information was received from the er nurse that the patient reported normally feeling stimulation from vns about twice a day. On (b)(6) 2015, the patient felt constant stimulation and experienced neck pain with stimulation. When magnet was taped to temporarily disable the vns, the pain was initially worse and then gone. However this repeated in a pattern where the pain was worse and then gone for a few minutes. Patient visited another hospital and the patient¿s generator was programmed off using the vns programmer. Since disablement of vns on (b)(6) 2015, patient did experience an increase in partial seizures due to loss of therapy. The patient was later seen by a nurse practitioner on (b)(6) 2015 and the vns was turned on to low settings of 0. 5/30/250/30/5/0. 75/60/500. Even at these settings, patient experienced coughing and voice hoarseness with stimulation and therefore medical professional decided to turn device off again and refer patient for vns replacement surgery. Diagnostics were performed and the impedance was within normal limits. The device was not at end of service. Chest x-rays were taken and no obvious issues were found. There was no trauma per patient prior to the events on (b)(6) 2015. Patient¿s previous vns settings prior to the reported events were unknown as the previous neurologist retired. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4840313
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« Reply #101 on: November 21, 2017, 02:56:02 AM »

Model Number MODEL 250
Event Date 05/19/2015
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator (pulse gen model 101, sn (b)(4)) was returned to the manufacturer for analysis. 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. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the vns patient was having a tingling sensation in her throat and experienced painful stimulation when a system diagnostic test was performed during an office visit on (b)(6) 2015. It was noted that the system test ¿didn¿t go through. ¿ the device was disabled the next day. The tingling sensation resolved after the device was disabled; however, the patient began twitching more. Review of the available programming and diagnostic history showed that an interrupted system diagnostic test occurred that caused an unintended change in device settings during the office visit. The patient had not been ramped up to an output current of 1ma likely due to tolerability issues. As system diagnostic tests run at an output current of 1ma, it is likely that the painful stimulation and tingling sensation were due to the system diagnostic test. The patient was referred for a surgical consult for further evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4851320
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« Reply #102 on: November 22, 2017, 03:43:35 AM »

Model Number 300-20
Event Date 03/01/2015
Event Type Malfunction
Event Description
It was reported that the patient's device was programmed back on during a recent clinic visit. The physician ran a system diagnostic test, which returned an impedance value within the normal limits. The physician later reported that he did not perform diagnostics in multiple positions during the clinic visit. The physician reported seeing an impedance value that indicated high impedance, but stated that impedance was ok during both system and normal mode diagnostic testing. No additional relevant information has occurred to date. No surgical intervention has occurred to date.

Event Description
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms). It was reported that a second diagnostic test was performed which was within normal limits. A third diagnostic test was performed with the patient's head turned which resulted in another high impedance reading indicating a possible intermittent lead break. The device was programmed off and the patient was referred for surgery. It was reported that the patient suffered a fall against a cabinet on (b)(6) 2015 where the patient hit the cabinet pretty hard. The patient suffered another fall in (b)(6) that resulted in an emergency room visit. It was later reported that the patient wants to hold off on lead replacement surgery since the patient has experienced a dramatic decrease in seizures since (b)(6). The patient wants to wait and see what happens.

Manufacturer Narrative
(b)(4): device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient reported that he no longer felt magnet stimulation during his daily morning swipe when the high impedance was initially identified. The patient also reported experiencing a slight tingling sensation at his generator site. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4812080
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« Reply #103 on: November 22, 2017, 03:44:27 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/24/2015
Event Type Injury
Event Description
It was reported that the vns patient¿s device was disabled for mri on (b)(6) 2015. After the mri, the physician attempted to interrogate the patient¿s device, but the patient reported experiencing erratic stimulation from her device when the programming wand was placed near the generator. The patient¿s device was interrogated and found still programmed off. The patient did not experience any erratic stimulation prior to device disablement. The physician programmed the patient¿s device back on to previous settings. The patient also reported having chocking sensations and pain and numbness in her left arm associated with stimulation on-times. It was noted that the patient was mentally delayed, but the physician stated that the patient¿s symptoms did not appear to be psychological. On (b)(6) 2015, the patient returned to the clinic and the patient¿s device magnet mode was disabled. The patient continued to experience erratic stimulation from her device. The patient went to the emergency room on (b)(6) 2015. The patient¿s device was disabled and the issues resolved. X-rays were taken and were reported by the physician to be unremarkable. The patient was evaluated by the surgeon on (b)(6) 2015. The patient¿s device was programmed on and tolerated the programming session well. The patient device was tested and showed normal device function. No further information relevant to the event has been received to date.

Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported the event as a malfunction rather than a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940403
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« Reply #104 on: November 23, 2017, 02:13:59 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
Date of event, corrected data: (b)(6) 2013. The event date was inadvertently reported as (b)(6) 2014 in the initial report.

Event Description
It was reported that the patient is undergoing an explant for vns due to experiencing some pain. Additional information was received that the patient's vns was inactive for the last 6 months. Patient experiences radiating pain in her neck. It was later reported that the patient was also diagnosed with pseudo seizures in (b)(6) 2013 based on video eeg. Vns was turned off a month prior to (b)(6) 2013 due to the sensation that it was shocking patient. In (b)(6) 2015, patient reported that she has been having pain with her vns at the implant site, tingling in her neck and can't breathe despite vns being off. Patient's generator was explanted on (b)(6) 2015. The explanted generator has not been received by the manufacturer.

Event Description
The cause of patient's pain, tingling and difficulty breathing while vns is disabled is unclear. The explanted generator is believed to have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4887499
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« Reply #105 on: November 25, 2017, 08:47:03 AM »

Model Number 103
Device Problem Battery issue
Event Date 06/01/2015
Event Type Injury
Event Description
The explanted device was discarded after surgery and will not be returned for analysis.

Event Description
It was reported that the patient had a generator replacement on (b)(6) 2015. Information obtained on (b)(6) 2015 that the patient was seen on (b)(6) 2015. It was noted that the patient was last seen in (b)(6) 2014 and seizures were well controlled. However, over the last 3-4 weeks she has noticed more frequent seizures. For most of her seizures, she usually has aura, which was described as tingling sensation in hands, followed by difficulties with getting the words out, lasting about a minute. Over the last 3-4 weeks, she had two episodes of generalized tonic-clonic seizures without any warning. The battery was interrogated and showed that the battery is low with ifi-yes. Over the last few months, she has also been complaining of worsening headache with dizziness spells. Attempts for further relevant information have been made but have been unsuccessful to date. The explant generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021879
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« Reply #106 on: November 29, 2017, 01:49:03 AM »

Model Number 103
Device Problem Migration of device or device component
Event Date 05/08/2015
Event Type Injury
Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.

Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394
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« Reply #107 on: December 04, 2017, 01:46:40 AM »

Event Type Injury
Manufacturer Narrative
Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on (b)(6) 2015 which included adverse events involving 7 vns patients. One patient presented vocal cord paralysis and underwent lead replacement. Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant. Two patients presented increased seizures and underwent vns replacement. Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead. The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis. The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein. The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5116364
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« Reply #108 on: December 09, 2017, 02:04:10 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 10/17/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was complaining of sternal pain with stimulation. However, the vns settings were lowered in steps and eventually disabled with no relief. The vns was programmed back on. The patient was referred for prophylactic vns generator replacement. Clinic notes were later received that indicated that the patient's pain was just below the site of his vns generator and was sharp with some mild radiation down the chest. Over the counter pain medication had limited effect and the patient was prescribed a topical lidocaine. Imaging was reviewed by the physician's office, but not the manufacturer, and no gross issues were noted. The patient was then referred for full vns replacement surgery per the clinic notes. The patient underwent only vns generator replacement surgery. The explanted generator was received by the manufacturer and is pending product analysis. It was later reported that the patient was still experiencing pain after the vns generator replacement surgery. The patient reported that for two days postoperatively, there was no pain, but shortly after, the patient began to experience the pain again. The pain was not associated with vns stimulation, but the patient reported that it was a tingling sensation that radiated into his neck. It was noted that the incision from the generator replacement surgery was well healed. There was no indication of damage on the lead during the vns generator replacement surgery. However, the patient is being referred for vns lead replacement surgery to attempt to alleviate the pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7030468
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« Reply #109 on: January 07, 2018, 03:26:54 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/23/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the physician and the patient that the patient was referred for explant as the patient experienced a lack of efficacy and the vns wasn't worth the side effects. It was also noted the device was programmed off months ago and the patient did not experience an increase in seizures due to the vns having been programmed off. A battery life calculation was performed on 01/05/2017 and reviewed on 01/10/2017. The in-house programming history database contained information from 07/30/2014 through (b)(6) 2014. No anomalies were noted and the impedance was within normal limits. Based on the information provided, and the parameters/diagnostic history found within the vns therapy programming history database, the patient had approximately 10 years remaining until neos = yes. The programming history database was reviewed on 01/10/2017. The database contained programming history from 07/30/2014 through (b)(6) 2014. No anomalies were noted. The patient was last programmed on (b)(6) 2014. The last diagnostics were performed on (b)(6) 2014 and showed the device was working as intended. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was later received from the physician's office. It was noted the patient experienced neck flexes and tingling. It was noted the something (the information was illegible) was ineffective in aborting seizures from 2014-2016. It was also noted that the output current had been decreased over 2014 and 2015 due to the reported side effects. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6238631
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« Reply #110 on: February 02, 2018, 03:11:21 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/23/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the physician and the patient that the patient was referred for explant as the patient experienced a lack of efficacy and the vns wasn't worth the side effects. It was also noted the device was programmed off months ago and the patient did not experience an increase in seizures due to the vns having been programmed off. A battery life calculation was performed on 01/05/2017 and reviewed on 01/10/2017. The in-house programming history database contained information from 07/30/2014 through (b)(6) 2014. No anomalies were noted and the impedance was within normal limits. Based on the information provided, and the parameters/diagnostic history found within the vns therapy programming history database, the patient had approximately 10 years remaining until neos = yes. The programming history database was reviewed on 01/10/2017. The database contained programming history from 07/30/2014 through (b)(6) 2014. No anomalies were noted. The patient was last programmed on (b)(6) 2014. The last diagnostics were performed on (b)(6) 2014 and showed the device was working as intended. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was later received from the physician's office. It was noted the patient experienced neck flexes and tingling. It was noted the something (the information was illegible) was ineffective in aborting seizures from 2014-2016. It was also noted that the output current had been decreased over 2014 and 2015 due to the reported side effects. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6238631
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« Reply #111 on: February 09, 2018, 03:06:25 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 12/29/2017
Event Type Injury
Event Description
It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7230517
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« Reply #112 on: February 10, 2018, 02:20:29 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/05/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that high impedance was detected on the patient's device. The patient was experiencing numbness on the left side of their face and left ear. No known surgical intervention has occurred, to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7171718
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« Reply #113 on: March 10, 2018, 02:41:44 AM »

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

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237189
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« Reply #114 on: March 10, 2018, 02:42:31 AM »

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

Event Description
It was reported that the patient was experiencing a tingling sensation at the electrodes that traveled from her ear to her head. Diagnostics were performed after the tingling started, and high impedance was present. The patient used the magnet to disable the device, and she planned on asking her physician to program it off. No surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7262565
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« Reply #115 on: March 19, 2018, 02:05:23 AM »

Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, the clinical specialist reported that she reviewed the patient's chest and neck x-ray report and they were abnormal with a possible disruption of the lead in the left neck. The physician recommended that a soft tissue neck report be performed. The neos flag was no for diagnostics and results of both the normal mode and system diagnostics were within normal limits. The soft tissue neck report indicated that the lead was intact. It was noted that each time diagnostics were performed, the system diagnostic's dcdc=3 and the normal mode dcdc=2 consistently. The patient has been experiencing shortness of breath within the last 6 months - 1 year and has had pain that runs down her arm and numbness when firing that also runs down her arm. There is no increase in coughing and the seizures are still monthly. The nurse practitioner had said that they ruled out cardiovascular and pulmonary issues with the shortness of breath. A battery life calculation was performed which showed 6. 37 years remaining until eri=yes. A/p and lateral x-ray images of the neck dated (b)(6) 2012 were received by the manufacturer. The generator was not able to be visualized due to the views in the x-rays provided. Therefore, whether or not the lead pin was fully inserted into the header of the generator could not be assessed. The electrode placement appeared to be normal and no lead discontinuities or acute angles were seen in the visible portions of the lead body. The patient later reported on (b)(6) 2012 that the device is causing her pain on and off throughout the day for about 5-6 plus hours a day. The patient was asked to be seen again regarding an evaluation of medications and vns. Good faith attempts for further information from the physician have been made but have been unsuccessful.

Event Description
On (b)(4) 2012, additional x-ray images were received, however these were the same x-ray images that had been provided by the physician earlier.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2794888
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« Reply #116 on: April 23, 2018, 01:06:47 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Garci´a-navarrete e, et al. Long-term results of vagal nerve stimulation for adults with medication-resistant epilepsy who have been on unchanged antiepileptic medication. Seizure: eur j epilepsy (2012), http://dx. Doi. Org/10. 1016/ j. Seizure. 2012. 09. 008.
 
Event Description
An article entitled ¿long-term results of vagal nerve stimulation for adults with medication-resistance epilepsy who have been on unchanged antiepileptic medication¿ was received. Forty-three patients were followed. After implant, patients were evaluated on a monthly basis increasing stimulation 0. 25 ma at each visit, up to 2. 5 ma. Medication was unchanged for at least 18 months since the stimulation was started. Of the 43 operated patients, 63% had a simulation or great than 50% reduction in seizure frequency. Differences in the responder rate according to stimulation intensity, age at onset of epilepsy, duration of epilepsy before surgery, previously epilepsy surgery, and seizure type, did not reach statistical significations. Most side effects were well tolerated. One patient reported an increase in the duration and intensity of his seizures. Twenty-two patients experienced side-effects. The most common were mild, consisting in hoarseness, neck tingling or occasional coughing at the time when the signal was on, all of which were usually well tolerated. Two patients had intermittent dyspnea, and another patient experienced occasional episodes of dysphagia with stimulation. Irritability was reported by two families, in the context of a general improvement in the level of alertness. Five had severe side effects, requiring their vns generators to be inactivated or explanted. Three of the 5 patients that stopped receiving stimulation had been responders. Reasons for explanation were infection in two patients, and odynophagia, in one patient. One patient had an exacerbation of a previous behavior disturbance, with severe aggressiveness, which improved when the stimulator was inactivated. Seizure reduction was maintained after the stimulation was stopped. Another stimulator was removed at family request, owing to a persistent abdominal pain. One explant due to infection is captured in this report: mfr report# 1644487-2013-01450. The other explant due to infection is captured in mfr report #1644487-2013-01453. The explant due to odynophagia is captured in mfr report #1644487-2013-01449. The explant due to abdominal pain is captured in mfr report #1644487-2013-01447. The report of increased seizure duration and intensity is captured in mfr report #1644487-2013-01444.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120504
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« Reply #117 on: May 05, 2018, 12:18:39 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 10/07/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing pain in the chest area that goes down her arm, neck pain, tingling sensation in their arms, headaches, back pain, right shoulder pain, and paraesthesia in the upper and lower extremities. Due to the pain, it was also reported that the patient was experiencing sleep disturbances. Device diagnostics were performed and reported to be normal limits. Per the physician's assessment, the cause of the events is due to the surgeon nicking the nerve during surgery. The patient was referred for surgery due to the pain. No additional relevant information has been received to date. No surgical intervention is know to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445025
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« Reply #118 on: May 22, 2018, 02:31:57 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
« Last Edit: September 01, 2018, 10:21:34 PM by dennis100 » Logged
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« Reply #119 on: June 08, 2018, 03:16:26 AM »

Device Problem No Known Device Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital for increased seizures and one episode of status, which was not normal for patient. The patient also experiences a tingly feeling in their neck. Patient's generator could not be interrogated at the time of report. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7542540

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« Reply #120 on: June 09, 2018, 02:01:12 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 11/01/2004
Event Type  Malfunction   
Event Description
It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day. The patient also reported that his left arm felt heavy and numb. Follow up with the patient's neurologist revealed that the neurologist was unaware of the events. During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics. The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7529711
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« Reply #121 on: June 09, 2018, 02:01:48 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/14/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to feeling constant pain at her generator site for an hour, which she believed to be continuous stimulation from the device, and she was also experiencing constant tingling in her arm. The physician stated that there were no reported traumatic events prior to the constant pain. The physician was educated on how to use the magnet to disable the device until it could be communicated with. It was reported later in the same day that the patient was feeling painful stimulation every 5-7 minutes. The patient had reportedly seen her neurologist and described her pain, but nothing was changed and the pain got worse so the patient went to the emergency room. The hospital staff called the next day to report that the patient was still having continuous stimulation, but they had not been using the magnet to disable the device as instructed. A company representative was able to communicate with the patient's device, and system diagnostics were within normal limits. The patient stated that she felt the stimulation when diagnostics were performed. The neurologist had come in the night before and programmed the device off. Since the device was programmed off. The painful stimulation resolved immediately after the device being programmed off. The patient had generator replacement surgery. The device has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7504920
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« Reply #122 on: June 12, 2018, 12:26:36 AM »

Model Number 304-20
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was reported that the pt experienced a seizure at the airport (was seizure-free for a few months prior to this). She was then brought to a hospital where they performed an mri. Per pt, her magnet was taped over her vns generator for the mri and during the mri, the magnet moved up her chest along the lead causing bruising. Following the mri, the physician at the hospital turned her settings down to the lowest possible settings against pt request. Pt then experienced 12 seizures in 12 hours and was put into a medically induced coma. Pt indicated she has some left-sided numbness and weakness since event and feels she has "left-sided neuro deficit". Pt also indicated that prior to the event, she was being weaned off her medications, which may have caused the seizure at the airport. Pt was seen by her physician a few weeks after event and the device was found to be functioning fine. The physician is ramping up the pt's settings and the pt is doing well. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662335
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« Reply #123 on: July 06, 2018, 10:12:00 AM »

Model Number 300-20
Device Problem Fracture
Event Date 06/04/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient reported that she had tingling sensation in her hands due to the vns. Later it was identified that high impedance was detected on the patient's vns through system diagnostics. The patient underwent a full revision of the vns. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7651952
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« Reply #124 on: August 14, 2018, 12:46:02 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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« Reply #125 on: October 06, 2018, 05:02:37 AM »

Model Number 300-30
Device Problem Fracture
Event Date 08/21/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A physician reported receiving an error message while interrogating a patient's device stating current could not be delivered. Diagnostics were performed on the patient's device and impedance was found to be high. It was noted that this was high impedance and indicative of a lead fracture. The patient's device was disabled and the patient was referred for surgery. It was noted that the patient was feeling tingling at the check and neck sites. A full revision surgery was performed. No device has been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877449
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« Reply #126 on: November 10, 2018, 02:49:57 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/16/2018
Event Type  Injury   
Event Description
It was reported from the physician that the patient was admitted to the hospital for symptoms of voice changes and neck pain and tingling. The doctor stated that it started 5 days prior and the patient came to the emergency room for the symptoms. The doctor asked what generator the patient had as he was unable to interrogate the patient. He later stated that everything resolved but it is unclear exactly what this means. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7970413
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« Reply #127 on: January 03, 2019, 08:59:06 AM »

Model Number 303-30
Event Date 09/09/2011
Event Type  Injury   
Event Description
On (b)(4) 2014, it was reported that the patient¿s generator and lead were explanted electively on (b)(6) 2014 as the patient reported no improvements to their seizure control since being implanted with the device and was experiencing some discomfort. The explanted lead and generator were returned for product analysis on (b)(4) 2014. The nurse later clarified that the discomfort the patient was feeling was in fact shortness of breath and numbness extending from the incision to the chin. The numbness was felt by neurosurgery to be due to injury to subcutaneous nerve during incision. The device had been disabled since (b)(6) 2012. The patient wanted the device off and refused parameter adjustment. The shortness of breath was due to device stimulation. It was stated that the explant surgery was not to preclude a serious injury. Diagnostics were not performed on the vns as the highest the patient was programmed to was an output of 0. 75ma. No causal or contributory programming or medication changes preceded the onset of the events. The nurse stated that she believed vns was not programmed to more therapeutic parameters due to poor tolerance and therefore was not effective. Product analysis was completed on the generator on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead is still underway.
 
Event Description
Analysis of the lead was completed on (b)(6) 2014. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3637198
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« Reply #128 on: January 04, 2019, 09:42:46 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
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« Reply #129 on: January 04, 2019, 09:43:45 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2018
Event Type  Injury   
Event Description
It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips. It was stated that this occurred all of the time. The physician's office stated the diagnostics were within normal limits. The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance. The patient later reported that she had been experiencing problems with her arm and could not move it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189859
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« Reply #130 on: January 11, 2019, 02:50:31 AM »

Model Number 300-20
Event Date 12/23/2013
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 7035 ohms). The patient reported that he felt stimulation and knew that he had damaged the device. The patient¿s device was subsequently programmed off. It was reported that the patient had a fall that is believed to have caused or contributed to the high lead impedance. X-rays were taken and were reported by the neurologist to be unremarkable. The notes indicate that during an office visit on (b)(6) 2013, the patient reported feeling a tingling sensation 2-3 times a week at his generator site. The neurologist stated that there may have been an issue with the patient¿s electrode as a warning message appeared during the office visit; however, diagnostic results during the office visit showed lead impedance (impedance value ¿ 3601 ohms) within normal limits. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product information was obtained. An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted generator and lead have not been returned to the manufacturer to date.
 
Manufacturer Narrative
Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Date of implant; corrected data: the previous mdr incorrectly reported the implant date. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative
Date of event, corrected data: the initial manufacturer report incorrectly reported the date of event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3766185
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« Reply #131 on: January 15, 2019, 03:26:31 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3816311
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« Reply #132 on: February 04, 2019, 03:08:41 AM »

Model Number 103
Event Date 08/01/2014
Event Type  Injury   
Event Description
It was reported that the physician has not seen this patient since (b)(6) 2013, although this was the physician who initially reported the events. The patient underwent prophylactic generator replacement on (b)(6) 2014. The explanted generator cannot be returned for product analysis as the hospital discards explants.
 
Event Description
It was reported that the patient started having worse seizures two months ago that are more frequent and are now gtc¿s, which he didn¿t have for years. The vns didn¿t seem to abort the seizures anymore with a magnet swipe and the patient no longer feel stimulation. On the patient¿s visit on (b)(6) 2014 the vns was successfully interrogated and the settings were increased, however the patient still feels that it is not working. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. Clinic notes were received which indicate that since the (b)(6) 2014, the vns does not seem to be reacting to magnet swipes. It was noted that before, the magnet would decrease the severity of the seizure and the patient had a subjective tingling in his throat. Now the patient doesn¿t have a tingling when the magnet is passed and the mother doesn¿t notice a change to his seizure severity. Additional information has been requested from the physician, but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4248445
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« Reply #133 on: February 09, 2019, 03:47:29 AM »

Model Number 302-20
Device Problem Fracture
Event Date 10/14/2013
Event Type  Malfunction   
Event Description
It was reported that a patient had been experiencing pain around her generator site since her last generator replacement. The pain was noted to have increased in frequency and severity over the course of the 5 years, and it was stated that she recently began having severe sharp pain at the site that worsens when trying to lift heavier items. The physician had instructed her to not pick things up. The patient now feels pain all the time and also experiences tingling in her hands and feet and pain in her ears. She was unsure if the newer events are related to vns. The patient stated not having any sort of trauma to the site. The pain is constant and seemed to be related to the placement of the device. The physician was recommending the newer device with the tachycardia detection as he believed it would benefit her seizure control. The patient further reported that she was experiencing sharp pains with vns stimulation. It was stated that she had issues with pain in the past and had settings adjusted at her last appointment, however the pain had now returned. At the patient's follow up appointment, it was noted that the patient's device was showing high impedance as observed from two different programming systems. The patient did not report any trauma that may have led to damage of the lead. It was further stated that after the device was disabled for the high impedance, the patient's painful stimulation resolved. Clinic notes were received also indicating that the patient was having more seizures with vns. Battery status was noted to be ok. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8223185
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« Reply #134 on: February 17, 2019, 06:23:40 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520
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« Reply #135 on: March 07, 2019, 02:08:11 AM »

Model Number 304-20
Event Date 04/30/2015
Event Type  Injury   
Event Description
A patient reported she was referred to an ear, nose, and throat (ent) doctor by her neurologist for evaluation of persistent hoarseness. The ent diagnosed the patient with vocal cord paresis/paralysis with the believed cause to be intubation during vns implant surgery. The patient reported that she also experiences choking, some coughing and tingling in the back of her throat. She stated that her voice is improving and she may have to undergo surgical repair. Post-implant medical records obtained from the neurologist indicate that surgery was uncomplicated, that the patient experienced a rough voice afterwards but no swallow dysfunction at that time, and that vns stimulation was well tolerated by the patient. On a subsequent visit it was noted that the patient was concerned that her voice had not come back yet. Vns parameters were increased at the visit and noted to be tolerated well by the patient, and the patient was referred to the ent. Medical records obtained from the ent describe persistent hoarseness starting immediately after vns surgery that has not worsened or improved since surgery, some dysphagia while eating & drinking, and occasional cough. Endoscopic evaluation of her larynx demonstrated left true vocal cord paresis/paralysis that appears to be complete. The ent records stated that the patient wished to continue with periodic observation and not pursue any treatment at this time. The patient was asked to return to the ent in 2 months. No known interventions have occurred to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5105420
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« Reply #136 on: March 08, 2019, 02:00:18 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient experienced increased seizures, body twitching, numbness in the right arm, and occasional left leg weakness. The physician attributed these events to the vns generator being at a low battery status. The physician clarified that the patient's current increased seizure levels are at/below pre-vns levels. The patient has been referred for vns replacement surgery due to these events. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8380159
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« Reply #137 on: April 07, 2019, 03:36:05 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Event Description
It was reported that after a patient's generator and lead were replaced, the patient noted that the "plug has turned facing up" and the lead was protruding. It was confirmed that it had not broken through the skin. It was also noted that the patient had felt an electrical current described as a "tingle" twice. Follow up with the physician stated that the protrusion was caused by the placement of the device during implant, and the report that the "plug has turned facing up" was not an allegation of migration. Per the physician, there was no device migration and the patient was now just concerned of the now-palpable lead. Non-resorbable sutures were confirmed to have been used to secure the generator during implant. The office was unaware of a tingling sensation or complaint. It was stated that the surgery was both for patient comfort and to preclude a serious injury of preventing exposure of the lead through the skin. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8441643
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« Reply #138 on: April 17, 2019, 07:08:01 AM »

Model Number 302-30
Event Date 07/26/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was found for a patient's device on (b)(6) 2016. The patient was reported to have had a fall recently, which may have caused a fracture and the high impedance. No known surgical interventions have occurred to date.
 
Event Description
Clinic notes were received for patient's referral for vns replacement. Notes indicate that the patient had two falls and reported pain in the left neck and tingling sensation. The doctor noted that the patient has a inactive vns. Previously the psychiatrist intended to replace the vns battery only when it reach eos. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5947860
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« Reply #139 on: April 24, 2019, 02:31:31 AM »

Model Number 303-20
Device Problems Fracture; Low impedance
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient¿s device showed low impedance. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the physician provided the device has had increasing impedances values since (b)(6) 2016, resulting in high impedance. The patient reported that she has not had a seizure in two months but she has had a mild shock near the generator site. The patient has denied any trauma or manipulation. No known surgery has occurred to-date.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The physician later provided the patient had high lead impedance still and was referred for lead revision. The patient states she has been having pain on the left side of the neck by the lead for the vns and has heard a cracking noise. She states that she is having pain on the left side of the chest where the magnet is and states there is swelling on that side, and feels like little knots. The patient states that when she lay on the left side of the neck it hurts and feels like it crackles. The patient states that she start having tingling like feeling 2 weeks ago, states that feels like having electric shocking.
 
Event Description
Follow-up from the physician¿s office provided that the swelling was not related to vns, even though the lead impedance is high.
 
Event Description
Follow-up was received indicating the patient does not want to go through with the revision due to her age and other health issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6191236
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« Reply #140 on: June 27, 2019, 12:11:05 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's generator replacement referral. Per notes , the physician noted tenderness on the chest wall when the vns was interrogated. Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest. At the surgeon's consult appointment, the surgeon mentioned that the patient was ok. The surgeon has deferred repositioning the device. No known surgical interventions have occurred to date.
 
Event Description
Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation. Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness. The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device. The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders. The physician reported that the surgery was not planned for the pain. The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7318737
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dennis100
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« Reply #141 on: July 05, 2019, 10:52:55 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was involved in a motor vehicle accident and following the accident began to experience painful stimulation in his jaw which prevented him from sleeping comfortably. The patient was given pain medication that did not resolve the pain. The patient reported the pain to be unbearable and went to the emergency room where the generator settings were not adjusted due to the risk of increases seizures. The patient's neurologist performed x-rays of the device and reported that the x-rays appeared normal and the diagnostics were within normal limits. The patient underwent generator replacement due to the adverse events that followed from the car accident and due to their jaw tingling. The neurologist indicated that the diagnostics were within normal limits. The suspect product has not been received to date. Multiple attempts were made to obtain additional information however, further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8678559
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dennis100
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« Reply #142 on: July 14, 2019, 04:40:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received from a visit dated (b)(6) 2018 providing the patient will have a pocket revision due to pain as an x-ray showed the generator has migrated. The patient explains the pain began in (b)(6). It was also noted the patient feels shortness of breath and numbness into her left shoulder and arm. Impedance on (b)(6) 2018 showed impedance within normal limits. Follow-up from the provider indicated the patient states the vns had moved after being placed. Generator replacement surgery. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7747257
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