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dennis100
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« on: May 17, 2018, 02:17:20 AM »

Model Number 102
Event Date 12/11/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
No further information has been received after good faith attempts have been made.
 
Event Description
A patient's father called and reported that their child was now having changes in his speech, hearing loss, ataxia, vertigo (with testing underway). Good faith attempts are underway for further details about the reported events and their relationship to their device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901715
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dennis100
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« Reply #1 on: May 17, 2018, 02:18:02 AM »

Model Number 102R
Event Date 10/27/2014
Event Type  Injury   
Event Description
It was reported that the vns patient fell in the bathtub on (b)(6) 2014 and subsequently was unable to perceive magnet mode stimulation on-times. The patient began experiencing ataxia and staring spells associated with confusion. The patient fell seven more times following the initial fall in a span of two days so the patient went to the er on (b)(6) 2014 and was admitted to the hospital. Follow-up revealed that the patient was later stable. The patient¿s device was tested and diagnostic results showed normal device function. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277287
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dennis100
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« Reply #2 on: May 17, 2018, 02:18:43 AM »

Model Number 102
Event Date 02/06/2012
Event Type  Injury   
Event Description
Clinic notes were received on (b)(6) 2012. Review of clinic notes dated (b)(6) 2012 note that the patient experienced three drop seizures for unknown reasons, which was an increase in drop seizures for the patient. The patient was hospitalized for bronchitis. The patient had more seizures and more ataxia. As a result, the patient's medications were adjusted. Notes dated (b)(6) 2012 indicated that the patient had 30 seizures in (b)(6), 24 seizures in (b)(6), and 10 seizures in (b)(6). The patient reportedly had three injuries at the end of (b)(6), all attributed to drop seizures, and the patient also had two lacerations. A limited-visibility chart monitoring seizure frequency was also attached. Data was charted from (b)(6) 2010 to (b)(6) 2012. The patient's seizure frequency appears to fluctuate but average about 20-25 seizures per month. Attempts for additional information from the physician have been unsuccessful. No further information was provided. A battery life calculation on (b)(6) 2012 indicated 0. 27 years to near end of service = yes.
 
Manufacturer Narrative
Eval code : analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2754831
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dennis100
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« Reply #3 on: May 17, 2018, 02:19:23 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/19/2016
Event Type  Injury   
Event Description
The patient later reported that she is having an increased sensitivity with clonic jerks, poor large muscle control upon movement, blurred vision, slurred speech, headaches, and a longer recovery time after seizures. She stated she was also having increased light sensitivity. The patient thinks some of the symptoms may be related to medications, but it is not confirmed. She did note that she had a 5 day veeg. She was taken off of 2 of her medications and had a decrease in symptoms of ataxia and stated the majority of her symptoms were medication induced. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The patient later reported that when her neck it flexed forward, or her hands are on her chest, the device seems to stimulate. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.
 
Event Description
Additional information was received from the physician stating the patient's symptoms were related to medications. Additionally, the physician did not believe the patient's pinching sensation was related to vns and no interventions have been taken due to the reported pinching sensation.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
The patient later reported she has had a lot of pinching around the axilla of the left breast incision, and displacement of the device upon moving around in bed. Attempts for additional information have been unsuccessful to date.
 
Event Description
Further information was received that the patient was experiencing an exacerbation of symptoms with vns including sleeping disturbances, ambulatory difficulties, and dysphagia. It was also reported that these symptoms started after her device was programmed back on in june 2017, indicating it had been previously turned off. No other relevant information was received from the patient's physician.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649
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dennis100
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« Reply #4 on: May 17, 2018, 02:19:59 AM »

Model Number 103
Event Date 07/01/2010
Event Type  Injury   
Event Description
The vns patient recently had surgery to replace the vns device in (b)(6) 2010 (previously reported in manufacturer report # 1644487-2010-01171), and since surgery, the patient had been experiencing pain in the left neck and the face. The physician had lowered the device settings to help with the pain. Over the next week the pain had resolved and the patient was doing well. It was then reported that the patient began experiencing intermittent seizure activity and confusion on (b)(6) and went to the emergency room. The patient was transferred to a different hospital, and the physician had made minor adjustments to the vns settings, and she was observed for several days but became very ataxic. After the physician's reviewed, the patient's medication, it was noted that the patient had taken an older (expired) bottle of lyrica to the hospital and was receiving twice the prescribed amount. After realizing the issue with the medication, it was corrected and the ataxia resolved and the patient was discharged. The patient was then for a follow up appointment at (b)(6) and the patient was experiencing migraine headaches, which per the physician is usually a sign of latent seizure activity. The physician opted to increase the device settings. Several days later, the patient then experienced a fairly severe migraine with confusion for the majority of the day, which seemed to resolve with no interventions. The patient is being closely monitored by the physician. At the time the patient was experiencing the migraines and confusion, it was also noted that the patient has not had a bowel movement for approximately a week, and the patient's appetite was diminished. The physician additionally explained that the patient is under a great deal of stress in her life at the moment, which could also be a contributory factor. At this time, the physician's assessment regarding the relationship of the events to vns is unclear. Good faith attempts to obtain additional information from the treating physician are currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828271
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dennis100
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« Reply #5 on: May 17, 2018, 02:20:40 AM »

Model Number 104
Event Date 09/25/2012
Event Type  Death   
Event Description
The physician reported that he did not know the cause of death, but did not think that the death was sudep or related to vns therapy. The death certificate was received and listed the immediate cause of death as acute cardiopulmonary collapse (approximate interval between onset and death: immediate) due to coagulopathy. Other significant conditions contributing to death, but not resulting in the underlying cause given was listed as infection, epilepsy, chronic encephalopathy and ataxia. The physician reported that he does not feel the patient's infection was related to vns therapy. The physician declined to provide any additional information.
 
Event Description
A funeral home called to return a explanted lead and generator from a vns patient who had passed away. No further details were provided surrounding the patient's cause of death and relationship to their vns. It was reported the patient had their products explanted in the last month but exact date of death not provided. Exact explant date not known. Analysis was performed on their explanted lead. The generator analysis is pending completion. An analysis was performed on the returned lead portions. Note that portions of the marked and unmarked connector boots, including a portion of the serial number tag was not returned therefore; it was not possible to verify the serial number during this analysis. The lead assembly (body) including the electrodes was also not returned; 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 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, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since portions of the marked and unmarked connector boots, the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
The generator pa was completed on (b)(4) 2013. Analysis of the generator 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 shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder found that a high impedance condition existed prior to explant. This is reported in mfr report # 1644487-2013-02260.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3180767
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