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dennis100
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« Reply #90 on: July 07, 2018, 04:35:14 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Information was received that the patient was experiencing pain was experiencing pain in the neck that was reportedly constant and worsened with stimulation. The device's settings were lowered due to the pain and the patient was referred for pain management. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7567558
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dennis100
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« Reply #91 on: July 07, 2018, 04:35:50 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/24/2018
Event Type  Injury   
Event Description
It was reported that the patient was feeling "electrical jolts" and recurrent pain at the vns site. Clinic notes received for the referral indicate that patient has recurrent left chest pain most likely related to vns placement as well as on occasion "feeling electrical jolts" suggestive of vns dysfunction/malfunction. It was reported that the electrical jolt occurs with stimulation on occasion but not every single time of stimulation. There is no pattern on when it occurs or with certain specific body movements. Surgical exploratory surgery was planned in regard to probable replacement of vagal nerve stimulator in view of chest pain as well as "electrical jolts" to preclude a serious injury but has not occurred to date.

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dennis100
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« Reply #92 on: July 11, 2018, 08:01:09 AM »

Model Number 302-20
Event Date 08/04/2010
Event Type  Malfunction   
Event Description
It was reported that a generator and lead were explanted due to unknown reason. Information from the explanting facility indicated the lead was explanted due to default but no further information was provided. Further follow-up by a company representative with the treating neurologist indicated the patient had a lead break as high lead impedance (7/limit/high) was received during a diagnostic test and the patient suddenly suffered pain. No patient manipulation or trauma was reported to have contributed to the high lead impedance and the neurologist believed the pain was caused by a broken lead which affected the surrounding areas. Moreover, no x-rays were taken by the site. The explanted generator and lead were returned to the manufacturer and underwent product analysis. Product analysis of the generator revealed 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. At the moment, the lead still remains in product analysis.
 
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=1854560
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dennis100
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« Reply #93 on: July 11, 2018, 08:01:48 AM »

Model Number 102
Event Date 02/17/2010
Event Type  Injury   
Event Description
A review of clinic notes dated (b)(6) 2012 found that the patient went to the emergency room the prior week with records from the emergency room dated (b)(6) 2012 showing that she had an increased frequency of seizures. The emergency room records also noted that the patient's white blood cell count in the urine was high suggesting a mild infection. The clinic notes continued to state that the patient had continued to have a change in her pattern of seizures as well described by her husband. The patient's husband stated that the patient seems to have a twisting movement with shaking in the right arm. The patient had one of these seizures during the appointment, and the physician noted that she appeared to be able to move to her husband and that it appears that the patient is seeking comfort from her husband. After the patient's vns was interrogated, an attempt was made to increase the pulsewidth from 250usec to 500usec, but the patient had significant changes in her voice and felt as if there was a sharp, stabbing pain in her neck when the stimulator turned on. Because of this, the stimulator was reversed and the settings were adjusted so that only minor change was made. According to the physician, the battery appeared to be satisfactory and the plan for the future was to adjust the patient's medication. Attempts have been made to get more information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816907
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dennis100
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« Reply #94 on: July 11, 2018, 08:02:23 AM »

Model Number 105
Event Date 01/01/2010
Event Type  Malfunction   
Event Description
During the evaluation of data from a clinical investigational device (model 106 aspiresr generator) used in a (b)(4) study, cyberonics identified a hardware design issue that can cause a portion of the stimulation output to be redirected from the intended path. Like the investigational device, the same circuit configuration is also present within the model 105 aspirehc generator which is a commercially marketed device. (refer to manufacturer report number 1644487-2011-02121 for the model 106 event). As a result of this issue, the stimulation current actually delivered to the vagus nerve can be less than what is programmed by the physician. This diversion of stimulation current can potentially lead to the following pt effects: delivery of stimulation current that is less than the magnitude required for effective therapy. Presence of neck pain, inflammation and/or swelling/edema at the lead electrode location in the neck; and/or pt perception of unusual stimulation or muscle twitching between the pulse generator and the lead electrodes implanted in the neck. The magnitude of the diverted current and its consequences depends on the pt's programmed parameters settings and physiology, tending to manifest only as the pt's programmed parameters (output current, pulse width, frequency, and on time) reach higher parameters. No pt injury has been reported as a result of this particular event. Cyberonics will be sending recommendations on programming to treating physicians who have pt's implanted with the model 105 generator. Cyberonics recommends that physicians continue their practice of titrating programming parameters for pts implanted with an aspirehc generator to achieve appropriate clinical outcomes, paying particular attention to reports of: lack or loss of efficacy. Pain, inflammation, swelling/edema in the neck area; and/or pt perception of stimulation or muscle twitching in the area surrounding the implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266742
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dennis100
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« Reply #95 on: July 12, 2018, 01:27:28 AM »

Model Number 103
Event Date 02/27/2009
Event Type  Injury   
Event Description
The patient reported that after the device was replaced in 2008 she had problems including increased headaches, jaw and neck pain anytime they increased her settings. The patient's device was then disabled on (b)(6) 2011 and ultimately explanted due to these adverse events. The explant date is unknown. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6124054
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dennis100
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« Reply #96 on: July 12, 2018, 01:28:01 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798
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dennis100
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« Reply #97 on: July 12, 2018, 01:28:33 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798
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dennis100
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« Reply #98 on: July 12, 2018, 01:29:07 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798
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dennis100
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« Reply #99 on: July 12, 2018, 01:30:09 AM »

Model Number 103
Event Date 10/01/2012
Event Type  Malfunction   
Event Description
A vns patient's caregiver reported that the patient was having "a lot of problems" since her last cluster that started (b)(6) 2012, which included one grand mal seizure. The patient and caregiver reportedly talked to the treating vns physician on (b)(4) 2012. The caregiver indicated that he was "pretty sure that the vns device is causing problems and may be malfunctioning somehow". The device was reportedly disabled for periods of time on (b)(6) 2012, and the patient feels much better with the device disabled. The caregiver was leaving the vns magnet taped over the device to keep the device disabled. The caregiver was planning on having the patient evaluated by the treating physician to perform diagnostic tests. Attempts for additional information from the treating physician have been unsuccessful to date.
 
Event Description
Additional information was received indicating the patient was seen by the physician again on (b)(6) 2013, and the patient/spouse and physician elected to turn the device on to low settings at 0. 25ma. All is reportedly well with the patient at this time and the patient will continued to be monitored.
 
Manufacturer Narrative
Age at time of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the age incorrectly. Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not list that intervention was taken. Date of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the date incorrectly.
 
Event Description
The patient had an appointment with the treating vns physician on (b)(6) 2013, and the company representative attended the appointment. The clinic notes for the office visit were received and reviewed. The patient's device was turned off on (b)(6) 2012, but the magnet output current was left at 1. 0ma so she could still swipe the magnet when she feels a seizure coming on. The interval month was met with a lessening in frequency and intensity of partial epilepsy. The patient has utilized this feature, per the clinic notes. The device was turned off because of tachycardia arrhythmia and epigastric pain and pyrosis which was felt potentially to be aggravated by the vns. The patient was wearing an monitor from the cardiologist, and the arrhythmia reportedly stopped after the device was turned off. She did not have any more episodes. The epigastric pain and pyrosis is believed to have begun around the same period of time as the arrhythmia. The physician does not believe the device is malfunctioning, as diagnostics are within normal limits. However, the physician noted that it is of interest that the patient has not had any cardiac sinus tachyarrhythmia or epigastric pain/pyrosis since the device normal output current has been turned off. The physician notes there is a questionable relationship of these events to vns therapy, and the epigastric pain/pyrosis is suspicious for vagotonia. At this time, the plan is to keep the device turned off (except magnet mode) and monitor the patient. Previously on (b)(6) 2012, the physician mentioned that the patient had a high pulse rate at 140 bpm at a previous dosing session (unknown date) but later dropped to 106 bpm. The physician did not think the issue was related to the vns at the time, but did refer the patient to cardiologist for evaluation. The physician noted at that time that nothing was found.
 
Event Description
Additional information was received from the patient indicating that she was taken to emergency room in (b)(6) 2012 due to tachycardia experienced during vns stimulation. She denied any reoccurrence of tachycardia since vns was "turned down. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2899181
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dennis100
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« Reply #100 on: July 12, 2018, 01:30:53 AM »

Event Date 06/06/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing bradycardia once in the or and again later with vns stimulation in the pacu following prophylactic lead and generator replacement surgery. The patient's heart rate dropped from the 60s-70s to the 30s while working on the vagus nerve in the or. The anesthesiologist then increased the patient's medication which returned the heart rate to normal. The generator was not attached to the lead at that time and therefore the bradycardia could not have been associated with vns stimulation. When system diagnostics were performed in the or, the heart rate remained normal. Following surgery, the patient's vns was set the same parameters as with the previous vns system and the patient began to experience bradycardia with stimulation on times. The nurse practitioner treating the patient lowered the patient's output current which resolved the bradycardia however the patient was having issues with coughing so it was lowered further to 0. 25ma. The patient does not have a personal or family history of cardiac issues. The patient does not have any pre-existing medical that would be expected to result in the bradycardia. The level of anesthesia used was described as "medium to deep. " the patient was not believed to have any abnormal vagal anatomy. In the pacu, the patient did not exhibit any symptoms that suggested he was experiencing bradycardia. There were no traumatic experiences other than the surgery. No possible triggers for the arrhythmia were noted. The patient was only on anti-epileptic medication at the time of surgery other than anesthesia and no medication changes had been made at that time. No other interventions were taken in the pacu other than the decrease in settings. The patient did not require an extended stay and the patient has been fine since surgery. The bradycardia has not recurred. The patient is still programmed to 0. 25ma due to the coughing and pain in neck. The patient has not had any issues with seizures at the lower settings. The patient's primary care physician has referred the patient to an ent specialist for an unknown reason. The patient is noted as feeling shortness of breath after talking for extended periods of time since surgery however the cause of this is unknown. Intraoperative diagnostics were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2644072
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dennis100
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« Reply #101 on: July 13, 2018, 02:40:15 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 05/15/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing some complications from her vns device and was referred for evaluation by the surgeon. The patient had acute spasmatic pain in the left neck and coughing lasting seconds whenever her magnet was swiped. However, the patient also experienced this 6-8 times per day spontaneously. The physician stated that there was no abnormality with the lead and that he suspected potential glossopharyngeal neuralgia. The physician prescribed gabapentin for the left neck paroxysmal pain. No surgery 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=7596790
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dennis100
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« Reply #102 on: July 20, 2018, 12:49:15 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was scheduled for surgery (unrelated to vns) and in preparation for the surgical procedure, the surgeon was programming the device off. Upon interrogation of the device, a high lead impedance warning message appeared. As a result, the surgeon opted to revise the lead and pulse generator since the patient was already undergoing a surgical procedure. Additional information was received revealing that the patient had sustained trauma to the chest site while playing volleyball. It is unknown when this trauma occurred. In addition, the patient's mother also reported that over the past 4-5 months, the patient had been experiencing painful and intolerable stimulation. The explanted lead and generator have been returned to manufacturer where analysis is underway. Good faith attempts to obtain additional information from the treating physician are also underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1854037
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« Reply #103 on: July 20, 2018, 12:50:21 AM »

Model Number 102
Device Problem No Information
Event Date 06/09/2015
Event Type  Injury   
Event Description
It was reported that the patient woke up with a lump around the generator and was experiencing painful stimulation. The device was programmed off and x-rays were ordered. It was later reported that the patient had a knot over the left neck area and will need to be seen by the surgeon. Clinic notes dated (b)(6) 2015 note that the patient started noticing a knot in the neck the day prior and that the generator was programmed off. It was also reported that the patient was experiencing confusion. No known surgical interventions have been performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Further follow-up revealed that the generator implant site was slightly raised. The confusion resolved when the generator was programmed off. There was no patient manipulation, programming or medication changes, or trauma that is believed to have caused the mass and the painful stimulation. X-rays were performed on (b)(6) 2015 which did not identify any adverse vns findings. It was reported that the patient has not yet been seen by the surgeon. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was seen by the surgeon who believed the device should be reactivated as there was nothing found wrong with the vns. The physician believes that the vns has been helpful for the patient; however, the surgeon is sending the patient for resective surgery consult. The patient reported that the device is fine, but is nearing end of service. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4893039
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dennis100
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« Reply #104 on: July 25, 2018, 06:02:00 AM »

Model Number 103
Event Date 10/25/2010
Event Type  Injury   
Event Description
Reporter indicated that the vns pt had been admitted to the hospital because he was in pain. The reporter stated the pain appeared to be occurring with stimulation. Diagnostics are normal as per the physician. The physician has been informed of possible ways to alleviate the painful stimulation. Further attempts for info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909984
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dennis100
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« Reply #105 on: July 25, 2018, 06:02:35 AM »

Model Number 103
Event Date 09/07/2010
Event Type  Injury   
Event Description
It was reported that a vns pt experienced painful stimulation and had his vns programmed off due to the painful stimulation. Moreover, the pt experienced a burning sensation at the site of the generator after the pt's device was programmed off. X-rays were taken and sent to the mfr. Review of x-rays indicated the generator placement appeared to be normal, and the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. There was no lead behind the generator. No obvious lead discontinuities or acute angles were observed in other portions of the lead body that could be assessed. At the moment good faith attempts to obtain additional info from the treating nurse have been unsuccessful to date as the pt was referred for eval.

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« Reply #106 on: July 25, 2018, 06:03:10 AM »

Model Number 102
Event Date 09/08/2010
Event Type  Injury   
Event Description
Reporter indicated a vns pt was hospitalized for evaluation of vns generator migration and painful stimulation that was occurring in the pt's left arm and chest at the generator site. The vns was to be disabled. The pt has had no trauma and does not manipulate the vns. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869526
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« Reply #107 on: July 26, 2018, 10:23:21 AM »

Model Number 102
Event Date 05/27/2014
Event Type  Injury   
Event Description
Additional information was received that the patient experienced neck pain and "intermittent buzzing", which started back in 2014. The buzzing sensation stopped when the patient's generator was replaced in 2014 but the neck discomfort continued to be present. The patient continues to have pain when turning the neck. It is unknown whether the neck pain is related to vns. It was reported by the patient's caregiver that it could be related to a muscle strain. No known interventions were taken regarding neck pain as patient has not consulted a physician regarding this yet.
 
Manufacturer Narrative

Event Description
The pain on the left side of the neck was reported to have started a year ago and is not occurring with vns stimulation. Patient was also reported to be wheel chair bound. It was noted that the patient would often turn the head to the right and stretch. X-rays were reviewed by the physician and the lead was observed to be coiled over the base of the left neck and in the mid left neck region.
 
Event Description
Further follow up indicated that the x-rays appeared normal and the vns device diagnostics were also normal. As the patient is hard to communicate with, the cause of the pain remains unknown and vns was not ruled out to be a possible factor. The x-rays were received and reviewed by the manufacturer. Two sets of electrodes were visualized in the neck region. The superior set of electrodes pertains to the current functional lead that was implanted on (b)(6) 2009 and the inferior set of electrodes belongs to the lead that was partially explanted on 09/10/2009. There did not appear to be any gross fractures or discontinuities that might explain the pain and painful stimulation.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to pain and repositioning of the generator pocket. The explanted generator 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. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced a stinging sensation at the generator site. It was noted that the patient feels that the device is still working. It was noted that the patient's mother feels like the generator is slipping lower. It was noted that the vns is causing the patient pain for the last month and that it seems to be slipping down in her chest. X-rays were performed which showed the generator at the left heart border. Attempts to obtain additional information have been unsuccessful to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3900196
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« Reply #108 on: July 26, 2018, 10:24:08 AM »

Model Number 102R
Event Date 11/27/2011
Event Type  Malfunction   
Event Description
Additional information received revealed that during revision surgery, the generator site was opened and the header of the generator had separated from the can. The lead itself appeared to be intact. With the generator header separation, lead impedance could not be assessed so a full revision was performed where the lead and generator were explanted and replaced. The explanted products have been returned to the manufacturer and product analysis is currently being performed. The dhr for the generator was reviewed and no non-conformances or other adverse conditions were noted in the generator's dhr.
 
Event Description
Product analysis of the explanted lead and generator has been completed. Note that a large portion of the lead assembly (body) including the electrode section 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 portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. 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. 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. The septa of the explanted generator were not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation" and "stimulation to unintended site"). A window was cut into the pulse generator case to access the feed-thru output connections on the substrate. Bench test connectors were attached to the negative and positive feed-thru wires, at the substrate, to perform a final electrical test. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. It is very likely that the identified, "detachment of component(s) header", occurred while the generator was implanted, and is related to patient trauma. Other than the header observation, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no non-conformance or other adverse conditions with the generator prior to shipment. Brand name, corrected data: initial report indicated the lead was the suspect device however new information received indicates the issue was most likely caused by the detachment of the generator header. Type of device, name, corrected data: initial report indicated the lead was the suspect device however new information received indicates the issue was most likely caused by the detachment of the generator header. Model #, serial #, lot#, expiration date, corrected data: initial report indicated the lead was the suspect device therefore the lead model number, serial number, lot number, and expiration date were provided however new information received indicates the issue was most likely caused by the detachment of the generator header. Manufacturer date, corrected data: initial report indicated the lead was the suspect device therefore the lead manufacturer date was provided however new information received indicates the issue was most likely caused by the detachment of the generator header.
 
Event Description
It was reported on (b)(6) 2011 that a vns patient walked into a door and the edge of the door hit the patient in the chest close to the generator site. Immediately following the hit, the patient began to feel stimulation more intensely in his neck and continued to feel the stimulation however the intensity lessened over time. Systems diagnostics were performed which resulted in ok/ok/1/no but normal mode diagnostics resulted in 7/limit/high. The device was programmed off and the patient was referred for x-rays. The patient's output current is 2. 75 ma. On (b)(6) 2011, systems and normal mode diagnostics were repeated which resulted in 7/limit/high/no. The patient was scheduled for a surgical consult and x-rays were sent to the manufacturer for review. A review of the x-rays did not show any anomalies however it was noted that in a certain portion of the lead, the lead was twisted onto itself suggesting some sort of patient manipulation or trauma. Clinic notes were received dated (b)(6) 2011 where the device was found to be programmed to 2. 75/30/500/30/3/3/500/30. Systems diagnostics resulted in ok/ok/1/no and normal mode diagnostics resulted in 7/limit/high/no. The device was programmed to 0 ma due to the high lead impedance and the patient's aeds were adjusted to compensate for the patient not receiving vns therapy. The notes indicate that following the trauma to the generator site, the patient felt discomfort in the throat with device stimulation. He also has an increase in his cough reflex. The patient had reportedly tolerated his settings until the trauma to the generator site and using the magnet to temporarily disable the device did not help. The discomfort occurred for 24 to 36 hours but has slightly lessened in intensity. If the patient was setting up and leaning forward, the discomfort was not as bad. The patient weighs (b)(6). 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=2389370
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« Reply #109 on: July 26, 2018, 10:25:08 AM »

Model Number 302-20
Device Problems Fracture; No Information
Event Date 02/19/2014
Event Type  Injury   
Event Description
It was later reported by the patient mother that the symptoms of vomiting, gas, and weight loss have continued since the device was programmed off. However, she also stated the symptoms have improved some. The patient mother stated she is still concerned about the weight loss and was directly attributing the issues to the presence of the device and that she wanted the device removed. The patient mother did explain that they had not yet been seen by a gi specialist. It was noted by the patient current physician that he was referred to a gi specialist and she does not believe the gi issues are related to vns as the patient had been programmed off for months.
 
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that this vns patient¿s device was disabled due to vomiting on (b)(6) 2014. It was previously reported recently had device settings turned back up and vomiting, pain, and stomach issues returned. In addition to reporting the device disablement, the physician stated that the events were occurring continuous, not just with stimulation, and were possibly related to vns; however, the patient had not been evaluated by a gastroenterologist. Interventions included disabling the device. The patient was reportedly experiencing pain in the throat and chest. On (b)(6) 2010, this vns patient caregiver reported that the patient had discomfort in the neck and chest region with stimulation. He also experienced voice alteration, dyspepsia, and difficulty sleeping with stimulation. The patient did not experience any adverse events when the settings were low. Follow-up at the time showed that there were no reports of trauma or manipulation; however, device settings were changed on (b)(6) 2010 where the output current was increased from 1. 50 to 1. 75 ma, and the signal frequency was increased from 25 to 30 hz. The patient did not have a history of sleep disturbances or dyspepsia prior to vns. The sleep disturbances and dyspepsia were related to device stimulation. The physician stated that the settings were lowered but then increased because the patient felt the device was not as efficacious at lower settings. In the past, the patient complained of pain, voice alteration, and emesis (if he already had concurrent nausea) during stimulation. He also complained of pain, too frequent stimulation, and that device stimulation would wake him up at night. There were no casual or contributory factors that preceded the onset of any of the events.
 
Event Description
It was noted during a periodic review of the programming history database that high impedance was noted on the patient's device on (b)(6) 2014. It was noted the patient's vns generator was programmed off on (b)(6) 2014. The high impedance found may be related to the previously reported events of sleep disturbances, dyspepsia, vomiting, pain, voice alteration, and the perception of an increase in frequency of stimulation.
 
Event Description
Additional information was received showing the physician still did not believe the gi related issues were associated with vns. However, it was noted that the other issues (voice alteration, sleep disturbances, painful stimulation and pain in the chest, neck, throat, and altered perception of stimulation were related to the high lead impedance that first occurred years ago. The patient was referred for replacement when the issues related to the high impedance first began (around (b)(6) 2014); however, the patient was a no-show to the appointment with the surgeon. The patient's device had been programmed off at that time. It was explained they later tried to titrate the patient's settings up again, unaware of the high lead impedance, which led to the continuation of the reported adverse events. The patient was programmed off again due to the return of the vns related adverse events. The patient had been referred for vns removal; however no known surgical interventions have occurred to date.
 
Event Description
It was further noted the surgery will be taking place due to patient comfort. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3728867
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« Reply #110 on: July 27, 2018, 10:42:18 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 05/10/2018
Event Type  Injury   
Event Description
It was reported that a patient was implanted in (b)(6) 2018 and his device was not turned on until recently due to scheduling issues. The patient was programmed to 0. 25ma. The patient returned today complaining of burning at the generator site. The patient was sent for x-rays, and the device was disabled. Ap and lateral x-rays of the neck and chest were available that displayed complete view of the neck and chest. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the generator was placed in the upper left chest, as expected. However, based on the angle of the image, the connector pin does not appear to be fully inserted past the connector block. The lead was observed in the patient¿s neck and was routed toward the patient¿s left chest. A strain relief bend and loop are present and placed per labeling. Two tie downs are present. Both tie downs appear to be securing the strain relief loop per labeling but no tie down appears to be securing the bend. No obvious fractures or sharp angles were found in the images. Note that a portion of the lead was routed behind the generator so it could not be assessed. Based on the images provided, the patient¿s painful stimulation may be related to incomplete lead pin insertion. Note that the presence of micro-fractures could not be ruled out. Patient was referred to surgery for consult. No additional or relevant information has been received to date.

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« Reply #111 on: July 27, 2018, 10:43:09 AM »

Model Number 103
Event Date 07/12/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was referred for surgery. The neurologist believed that there was an issue with the patient¿s lead. The patient¿s device was tested and system diagnostic results showed normal device function at the time. The neurologist stated that the patient¿s device showed an ifi condition and that the patient was no longer feeling the same intensity from stimulation. Further follow-up revealed that the patient had a surgical consult on (b)(6) 2014. The surgeon stated that generator and lead replacement was needed and that the patient¿s device was ¿dead. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. 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 diagnostics were normal. A full replacement of the vns system was performed by the surgeon on (b)(6) 2014. During surgery, the surgeon noticed that the lead wire was sutured to the fascia in the chest, rather than suturing the generator to the fascia as indicated in labeling. There was also a kink in the lead wire in the chest area, but no specific lead damage was observed. The surgeon wondered if perhaps the suturing of the lead wire to the chest was causing the patient painful stimulation in the chest area and clinical symptoms, or whether it was due to generator migration. It was also noted that the neurologist thought the patient's device reached ifi = yes quickly, but based on the estimated battery life per labeling at the provided settings in (b)(6) 2013, there is no evidence to suggest premature depletion. The caregiver reported that manipulations or intense movements was not an issue with this patient. The patient's pain has resolved since full revision surgery.
 
Event Description
It was initially reported on (b)(6) 2013 via a (b)(4) message that the patient was having breathing problems during deep sleep since vns implantation. A video was posted of the patient's sleeping issue. The patient's caregiver reports that she is certain that these problems started with vns implant and have continued to get worse as settings increase. Later on (b)(6) 2013, the caregiver reported that she has brought up the sleeping issue concern with the patient's vns neurologist and primary care physician (pcp), but the physician did not seem concerned and said it was "normal," but she feels that this is not. The caregiver said that she understands that there are warnings for patients with pre-existing issues and being evaluated prior to vns for things like this, but she felt that the patient does not have any physical issues that would cause her to have a pre-existing condition that would be exacerbated by the vns therapy. She did confirm that the patient has not had a sleep study done since so far her pcp did not think it was needed and also has not referred her to an ent. The caregiver then went on to explain that during the episodes, the patient's oxygen levels are dropping into the 80s, especially more recently and was not an issue in the past. The issue only occurs during deep sleep, is not position dependent or due to an illness like a cold, is present when breathing through mouth or nose, or if the patient is lying flat or elevated. The patient had generator replacement on (b)(6) 2012, and the caregiver reported that this issue was present with the patient's previous generator implanted on (b)(6) 2009. (the sleeping issues with the previous generator are captured in mfg report number: 1644487-2013-01308. ) however, the issue has worsened since generator replacement in 2012. She said that as far as she knew there had not been any attempts to alleviate the issue with settings adjustments, however when the patient's output current was lowered (settings unknown) for a few days the patient had increase in her seizure frequency, so the patient's settings were increased again. That patient is stilling having about 20+ seizures every 24-hours and has several seizure-types due to a traumatic brain injury several years ago, which appears to have several focal points in her brain, so her treatment options are limited. The patient was started on a new medication about a year ago. The caregiver does not feel that cpap is an option due to the patient's seizures which have been violent and would likely cause the cpap to be damaged within a few days. The caregiver was suggested to discuss these issues with the physician for further discussions and suggestions. Follow-up with the treating vns neurologist was performed which revealed that the patient was evaluated on (b)(6) 2013. She reported that she was not aware of the patient's breathing troubles and lower oxygen levels (below 80) until the vns manufacturer contacted her office. The patient/caregiver had not reported this to her until her appointment on (b)(6) 2013. The caregiver brought in the video of the patient sleeping to show the physician. The physician reported that the breathing troubles appear to be related to stimulation, so she lowered the output current and pulse width. She further indicated that it is "clear that the patient gets gassy during stimulation. " she reported that if this does not resolve the issue, she plans on lowering the stimulation further. She stated that when the patient/caregiver disabled the device with the vns magnet, the issues resolved so it is "obviously" related to vns. The physician lowered the output current to 2. 5ma and pulse width to 250usec. However, the patient did not want the settings lowered, but the physician elected to turn down the settings to see if this helps the breathing troubles. No additional information was provided by the physician as she was not previously aware of the breathing issues during sleep. Attempts for the product information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3102380
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« Reply #112 on: July 27, 2018, 10:44:14 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 02/22/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced fainting and stimulation throughout the chest when the vns was stimulating. The physician programmed the vns generator off and the symptoms resolved. However, it was reported that during an mri, the patient felt stimulation during an mri and loss consciousness, hitting his head and breaking his ankle. Follow up with the company representative revealed that the patient's magnet output current had not been disabled. The patient reported the stimulation has uncomfortable/painful. The vns was then fully disabled. It was reported that the diagnostics were within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7350087
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« Reply #113 on: July 27, 2018, 10:45:02 AM »

Model Number 304-20
Event Date 06/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, this patient reported that she was experiencing pain just above the generator site (related to the previous chest pain) and that she had been to the er numerous times for this discomfort. The pains reportedly began one week prior. The patient also indicated that this was in addition to the breathing problems and chest pains that began with vns implant. When the patient was at the hospital, x-rays were taken with no noted issues, and there was no infection. The patient was given pain medication. The patient noted that the device was previously turned off. This morning the settings were turned down, and the issues did seem to improve. Attempts for additional information have been unsuccessful.
 
Event Description
On (b)(4) 2013, it was reported that this patient wanted her device removed. The patient reported that she developed a blot clot in the left neck. She was informed by her surgeon that the she bled quite a bit in surgery and had to be transfused intraoperatively. Three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking. She reported that she saw a pulmonologist who performed a bronchoscopy and informed her that her left vocal cord is almost completely paralyzed and that he could see the lead next to the vocal cord. The patient was last seen on (b)(6) 2013 at which time her settings were adjusted. (increased settings have not affected her chest pain and shortness of breath adversely: it was no worse and no better. ) attempts for information have been unsuccessful. Surgery is likely and will be captured in mfr report #1644487-2013-01510. The patient had earlier reported that two days after her system was implanted she went to the hospital because she could not breathe or swallow. The patient was turned on one month later. The patient indicated that the swallowing issue was only occurring a couple of times per week and not necessarily coinciding with stimulation on times. The breathing issue occurred all of the time and was worse with stimulation. The patient also experienced painful magnet stimulation at the electrode site (magnet output current: 1. 0 ma). The patient also had incidents of pain at the generator site for the past two to three months. The patient did not experience any trauma. At the hospital, her vitals were noted to be fine and everything was okay. The patient¿s physician was unable to provide information as to the cause of the events. The patient also reported that a ct performed after surgery showed a blood clot at the lead site. Follow-up at a patient appointment in september showed that the pulsewidth and frequency were too high. Once the settings were adjusted, the patient was fine. Follow-up with the surgeon¿s office showed that the patient was seen for implant and again in (b)(6) for post-op follow-up and one more time in (b)(6), at which time she reported the pain and swallowing; however, these were determined to be only the result of the patient¿s settings. At the follow-up appointments, the patient was healing well without any complications. Follow-up with the neurologist showed that the patient was doing well and was seen in (b)(6)with no complaints. The patient was doing well with seizure control. The relationship of the blood clot to vns was unknown. The patient was on clonazepam, lamictal, keppra, lamotrigine, haproen, and vimpat at the time of the event. No causal or contributory medication changes precede the onset of the thrombosis. To the physician¿s knowledge, the patient did not have a medical history of thrombosis, and there were no pre/co existing medical conditions which may have contributed to the event. No medical interventions were taken. The patient was last seen on (b)(6) 2012, and reported no new symptoms or issues.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was hospitalized for several days due to shortness of breath. The patient was admitted to the hospital on (b)(6) 2014. The patient reported experiencing pain at her generator site while hospitalized but states that the pain had since resolved. The patient was also having seizures frequently. While hospitalized, the patient¿s device was found to be disabled. The neurologist at the hospital stated that the patient was suffering from depression and was taking too many aeds. Further follow-up revealed that the patient was seen by her following neurologist. The patient reported that her device had been disabled for two months prior to the office visit and that she was experiencing pain. The neurologist did not believe the pain was related to vns as the pain was not occurring at the patient¿s implant sites. After her office visit, the patient went to the emergency room due to a seizure on the bus that caused facial lacerations.

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« Reply #114 on: July 27, 2018, 10:45:40 AM »

Model Number 304-20
Event Date 11/15/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 the surgeon reported that the patient was seen that day and has vocal cord paralysis. The patient recently underwent a full revision surgery on (b)(6) 2012 and on (b)(6) 2012 was turned back on the previous settings by the neurologist. The device was disabled at the (b)(6) 2012 appointment with the surgeon and the patient was in tears and could not talk during stimulation times. There was painful stimulation in her neck and the patient was crying and bent over during the on-times. The patient was going to return in two weeks for an ent workup regarding her left vocal cord paralysis. (b)(4) attempts for additional information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2871669
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« Reply #115 on: July 28, 2018, 08:23:12 AM »

Model Number 102
Event Date 07/01/2010
Event Type  Injury   
Event Description
It was reported that the pt had a stress test, and ever since then, the pt has been "tailspinning". The pt is now having an increase in depression, suicidal ideations, and pain during device stimulation. The physician adjusted the pt's setting to address the painful stimulation, but the depression has continued. The relationship to pre-vns baseline depression levels is unk. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1908113
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« Reply #116 on: July 28, 2018, 08:23:52 AM »

Model Number 103
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the pt that when she was walking into a casino, she experienced a painful stimulation in her chest area. There were no believed security detectors when she entered the door. The pain was said to have eventually went away and then over the weekend after she got home she began experiencing painful stimulation every min. Her husband took her to er at one facility and was later transferred to another er facility. The pt was disabled at that time and told to f/u with her treating neurologist. The pt later requested that her pcp refer her for explant of the device due to the painful stimulation she was experiencing. Two weeks prior to the report, the pt had an increase in her settings, but the pain didn't show up until a few days prior to the report. There has been no known trauma or manipulation to the device. The pt did go through airport security and was patted down at that time. A search performed in the mfr's programming history database indicates that the last known diagnostics performed on (b)(6) 2010 were within normal limits. During the explant surgery, the surgeon indicated that the leads were twisted due to pt manipulation. It appeared that the pt flipped generator over and over again. The lead was straight, then twisted, then straight again. The explanted lead portions and pulse generator have been returned to the mfr, but has yet to be completed on the pulse generator. Note that a large portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete eval 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 except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Good faith attempts to obtain add'l info have been unsuccessful to date.

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« Reply #117 on: July 31, 2018, 03:45:18 AM »

Model Number 300-20
Event Date 07/30/1998
Event Type  Injury   
Event Description
Reporter indicated that a vns pt has had painful stimulation in the throat since the vns was implanted on (b)(6) 1998. Vns setting changes have not helped alleviate the painful stimulation, and the reporter has recommended the pt have vns lead and generator replacement due to the painful stimulation. Surgery is likely, but a surgery date has not been set.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1892642
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« Reply #118 on: August 02, 2018, 01:46:49 AM »

Model Number 102
Device Problem Device operates differently than expected
Event Date 11/01/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data : the previously submitted mdr inadvertently did not provide the udi# of the suspect device.
 
Event Description
It was reported that the vns patient has had adverse events ever since she was implanted. It was reported that patient has had earache and inflamed tonsils, especially on the left side, as well as terrible lethargy. It was reported that the device output current was gradually increased but the patient then complained of severe earache and pain in her tonsil, the output current was then decreased to 0. 50ma which relieved patient's pain tremendously. It was reported that the patient was treated for tonsillitis with earache, which treatment was inefficacious. Patient is planned for a week long in hospital tests at the beginning of march 2016. Additional information was received that patient has had episode of tonsillitis before vns implant, but not tinnitus. The pain started when the stimulation was switched on. The earache occurs when the device stimulates and continues. The patient was treated for tonsillitis because the tonsil was inflamed, but it was not necessarily diagnosed as tonsillitis. When the stimulation was switched on, the doctor could actually see it affecting the tonsil on the left. It was reported that device diagnostic test gave normal results.

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« Reply #119 on: August 02, 2018, 01:47:25 AM »

Model Number 103
Event Date 11/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician at the hospital that the pt was experiencing painful stimulation at the electrode site. Device was checked and confirmed to be functioning within normal limits. After lowering the settings, the pt was doing fine. Follow up with the treating physician revealed that the device was turned off as pt's pain was not resolved after reducing the vns settings. Pt did well initially but the event came back. The pt requested to have the device turned off as he could not tolerate the pain and he was referred to the surgeon for a possible revision surgery. Per physician, the pain was quite serious for the pt and therefore, he had to refer the pt for a revision of vns. Surgery has not been planned at the moment but it will likely take place. The pain occurs with vns stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943832
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