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dennis100
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« Reply #30 on: April 11, 2018, 02:40:23 AM »

Model Number 102
Event Date 09/01/2012
Event Type  Injury   
Event Description
The patient reported her experience to the fda in medwatch report mw5061274. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totaled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same. " mfr report #1644487-2016-01151 reports the potential infection from replacement surgery on (b)(6) 2013 per the following portion of the patient's report: "i had yet another surgery and infection".
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
On (b)(6) 2013, it was reported that the vns patient had an infection one month after implant that required explant of the vns. The patient was scheduled for re-implantation of the vns on (b)(6) 2013. The patient underwent re-implant surgery on (b)(6) 2013 and the surgeon placed the leads on her right side due to a previous surgery that caused her right vocal cord to be paralyzed. The surgeon stated that after her previous infection on the left with the original implant, he didn't want to take the chance of damaging her left vocal cord. The previous surgery that caused the right vocal cord paralysis was a cervical fusion done may years ago. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead were sterilized prior to distribution. Good faith attempts for further information from the physician have been unsuccessful.
 
Manufacturer Narrative
The serial number provided for the generator provided on page 4 of the medwatch received indicated "(b)(4)". This is the generator that was implanted in 2013.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119822
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dennis100
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« Reply #31 on: April 29, 2018, 01:59:33 AM »

Model Number 302-30
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Additional information was received from the reporter on (b)(6) 2013 that patient had her generator programmed off several years ago and is still having seizures despite currently being prescribed aeds. It was also noted that the patient¿s 48 hour video eeg results showed seizures as having occurred.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s vns was turned off due to high impedance. The patient is having seizures. When they turned the device on, they ran diagnostics and the lead impedance was normal. They left the device turned off, added mycoline to the patient¿s medication, and she is doing better. They will turn the device back on if her seizures continue.
 
Event Description
The reporter indicated via phone call on (b)(6) 2013 that the patient had experienced a measurement of high impedance. It was reported that the patient's group home had disabled the generator as a result of the reading of high impedance. It was reported that the patient's physician would soon be performing a system diagnostics test on the patient's generator and that he might refer the patient for a surgical consult for a possible full revision of the generator and lead. A review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Follow-up with the physician on (b)(6) 2013 indicated that the patient's group generator was disabled on (b)(6) 2005 by the patient's group home because the patient had also been experiencing a lack of efficacy. A prior reported file indicates that the device was disabled because the patient was additionally experiencing cognitive changes at the same time as the report of lack of efficacy. Attempts for additional information are still in continuation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3163985
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dennis100
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« Reply #32 on: September 13, 2018, 01:55:25 AM »

Model Number 101
Event Date 10/18/2011
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The implant card was received which also reported that the generator replacement surgery on (b)(6) 2012, was replaced due to battery depletion with near end of service=yes. Follow up with the physician's office confirmed that the patient's "cognitive difficulties" are not believed to be related to vns. Product analysis for the generator was completed, and the reported end-of-service allegations were confirmed. An open can measurement of the battery voltage determined that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. The reported "failure to program" was duplicated in the lab and determined to be the result of normal battery depletion. With the exception of the eri parameter, the device performed according to functional specifications. There were no abnormal performance or any other type of adverse condition was found with the generator.
 
Manufacturer Narrative
Device manufacture date, corrected data: the initial report inadvertently did not include the specific date of manufacturer of the suspect device.
 
Event Description
It was reported that the physician could not interrogate the patient's vns and did not even realize the patient had a vns. The patient could not recall anything related to vns since 2002, but is a difficult historian. At this time, it is unknown if this is due to normal end of service or not. Last record of battery check is from 2005 and everything was okay. The patient has also had some "cognitive difficulties", but it is unknown if these are related to vns. Patient's seizures have not increased. Patient has been referred for generator replacement, but it has not occurred to date.
 
Event Description
The patient had generator replacement surgery due to end of service on (b)(6) 2012. The replacement generator was programmed to the patient's previous settings. The generator was received by the manufacturer, but product analysis has not been completed to date. The return product form was received and indicated the reason for replacement was due to battery depletion with eri=yes.
 
Event Description
It was reported that the patient's surgery was canceled as the patient has not completed cardiology clearance, and it has not occurred to date. Follow-up with the physician reveals that they feel the generator is at end of service as it has been implanted for quite some time and they have had no issues with their programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2348119
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dennis100
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« Reply #33 on: October 26, 2018, 01:40:17 AM »

Model Number 101
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported that the patient was scheduled for vns explant due to an unknown reason. Upon further follow-up, the nurse at the treating physician's office reported on (b)(6) 2012 that the patient's device is being scheduled for explant because it was turned off some time ago for an unclear reason. She thought it may have been due to a low heart rate. Follow-up with the nurse revealed the patient had generator replacement on (b)(6) 2001, and on (b)(6) 2001, the patient was admitted to the hospital with low sodium of 120 on carbamazepine and levetiracetam. She was taken off carbamazepine, and was readmitted on (b)(6) 2001, with cognitive abnormalities on levetiracetam and phenytoin. She has a history of episodic tachycardia and is on betablocker since 2007. Patient was started on ltg in 2008, and the vns was turned off on (b)(6) 2008, due to tachycardia without underlying cause. Per the nurse, after having her device turned off for several years, the "episodic tachycardia remains unexplained, but she is taking a beta blocker". A note from the cardiologist dated (b)(6) 2008, stated that the patient's seizure medications were reduced and she had one significant seizure episode. Since then, she had more palpitations and some vague chest pain. Patient returned on this day for a follow-up due to recent increase frequency of palpitations. Patient had episodes of seizures about every two to three weeks, and it was noted that the patient had a vagal nerve stimulator placed. After the seizure episodes, the patient had palpitations usually at night and lasted for less than minutes, most consistent with probable premature beat feelings. The metoprolol sode was increased to "25 mg daily for pac or inappropriate sinus tachycardia suppression. She also had some vague chest pain and was initiated for cad evaluations. She also has some exertional fatigue. Otherwise, she denied any other cardiac-related complaints". Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the supplemental report #1 inadvertently reported the date the information was received by the manufacturer incorrectly. The correct date field was (b)(4) 2012.
 
Event Description
Additional follow up with the nurse was performed who reported that the details regarding the events are not remembered. The patient was complaining and being treated for tachycardia. The vns was turned off for an mri on (b)(6) 2008, and the patient had it turned back on (b)(6) 2008 reportedly. When trying to turn the output current on, the nurse reportedly "could not get the output past 0. 75ma" due to extreme coughing. Although the previous output current was 2. 0ma, the site attempted to turn the current to 1. 75ma but the patient experienced violent coughing. Current decreased to 1. 5ma with on time every 3 minutes and off time at 1. 8 minutes. The settings were not tolerated, and continued to not be tolerated at 1. 25ma. Current was therefore decreased. Due to the tachycardia, the vns was turned off soon after per the nurse (which was observed on (b)(6) 2008). Later on (b)(6) 2009, the notes indicated that the device had been turned off with no exacerbation of seizures over 6 months. Patient requested to have the device removed for reasons of pain and discomfort at night. Patient was referred for surgical consult for vns explant. Notes dated (b)(6) 2009 revealed that the patient requested to have vns removed, "as it has not been helping and is somewhat uncomfortable moving around in the pocket".
 
Event Description
Follow-up with the implanting surgeon revealed that from the generator replacement in 2008 there was no mention of a suture being used in the operative note of use of suture to secure the generator to the fascia. Training was provided to the surgeon's office regarding labeling recommendations that a non-absorbable suture be used to secure the generator to prevent such occurrences of generator migration.
 
Manufacturer Narrative
 
Manufacturer Narrative
Suspect medical device, lot number, expiration date, corrected data: the initial report did not report this product information at that time. Device manufacture date, corrected data: the initial report did not report the manufacturer date at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883274
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dennis100
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« Reply #34 on: November 01, 2018, 02:54:23 AM »

Model Number 106
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported by the vns patient's mother that whenever the patient's device settings were adjusted, the patient would experience increases in auras, seizures, post-ictal periods, headaches and twitching. The patient also began showing signs of cognitive impairment. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5444672
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dennis100
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« Reply #35 on: November 02, 2018, 08:44:56 AM »

Event Date 04/10/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient had full revision surgery on (b)(6) 2012. The explanted products have been discarded and will not be returned for analysis. Lead information remains unknown. Good faith attempts for further info about the reported events have been made but no further information has been attained.
 
Event Description
X-rays were received and evaluated by the manufacturer. The generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appeared to be intact. The lead connector pin appeared fully inserted into the generator connector block. Part of the lead was visible and could be assessed, part was behind the generator. Electrodes appeared correctly aligned on the vagus nerve. One possible acute angle was observed, near the generator. No obvious lead break could be identified in the visible portion of the lead. Additional information was received from the treating physician indicating the patient was experiencing absences and seizures and wanted a surgical decision. At the moment full system replacement surgery is panned but has not been scheduled.
 
Event Description
It was reported by a company representative that high impedance was observed at a follow-up appointment. The patient¿s generator was programmed off and patient was referred for x-rays. Additional information from the treating physician indicated the patient has been having seizures over the last months and often falls, which could attribute to trauma to the device. The last setting check was done in (b)(6) 2012 in which there was no diagnostic performed on the generator. At the moment, the patient is having cognitive changes in which it is noticed an "empty stare", but no increase in seizures. At the moment revision surgery is planned but has not been confirmed.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2559768
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dennis100
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« Reply #36 on: June 19, 2019, 04:27:33 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/28/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing an increase in seizures which was causing cognitive changes. The physician believed the cause for the increase in seizures was due to the patient not being able to swipe the vns magnet and the battery being implanted for so many years. However it was noted that the battery indicator was green, indicating it was still functioning. The patient was referred for a generator replacement however no surgical interventions are known to have occurred to date.
 
Event Description
The patient underwent surgery to have the vns generator replaced prophylactically. The explanted generator was received and is pending product analysis.
 
Manufacturer Narrative
 
Event Description
Analysis was completed on the explanted generator. Upon receipt the generator would interrogate normally and the battery indicator was eri = no, indicating that the device's battery was not low. The reed switch, which activates stimulation when the vns magnet is swiped, was tested and showed to be functioning to specification. The output signal of the generator was monitored for more than 24 hrs, while the generator was placed in a simulated body temperature environment. The results showed no signs of variation in the generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The device performed to functional specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6805604
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