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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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7609529
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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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