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dennis100
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« on: August 20, 2018, 03:29:13 AM »

Model Number 102
Event Date 01/01/2004
Event Type  Injury   
Event Description
Treating cardiologist reported that a vns patient was experiencing black out spells. The patient had her generator replaced for an unknown reason and is still experiencing the blackout spells. The physician reportedly believes the patient is having bradycardia due to vns therapy which is causing the patient to have the black out spells and then subsequently a seizure. Physician states that he plans on having the device programmed off to assess vns therapy relationship. Attempts for further information have been used to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1269757
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dennis100
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« Reply #1 on: August 20, 2018, 03:30:02 AM »

Model Number 102
Event Date 06/28/2011
Event Type  Injury   
Event Description
Additional information was received regarding the patient. The syncope that was reported was unrelated to vns.
 
Event Description
It was initially reported the patient was experiencing blackout spells that were speculated to be syncope related to hypotension; however, it was not confirmed that the blackouts were unrelated to seizures. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301698
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dennis100
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« Reply #2 on: August 20, 2018, 03:30:57 AM »

Model Number 105
Event Date 01/01/2014
Event Type  Injury   
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: additional information indicates that the patient was hospitalized.
 
Event Description
The patient reported that she has experienced a recent exacerbation of cardiac arrhythmia. The patient attributes this to vns and reported that she is on low settings. The patient indicated that she has a history of arrhythmia for which she is followed by a physician. The patient reported that experienced five straight days of severe arrhythmia, but that it is not as bad anymore. The patient reported that she was originally diagnosed with premature ventricular contraction two to three years ago. The patient indicated that she had a feeling vns therapy affected it. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient was briefly hospitalized in mid-(b)(6) 2014 after experiencing a blackout. The treating physicians attributed the blackout to either bradycardia, cva or a clotting disorder. The patient¿s description of the event suggested that the event was not arrhythmia but an absence seizure. The patient was last seen by her neurologist on (b)(6) 2014 so the neurologist is unable to provide any feedback regarding the event. The patient has not been seen by a medical professional to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3688946
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dennis100
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« Reply #3 on: August 20, 2018, 03:31:43 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3106486
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dennis100
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« Reply #4 on: August 20, 2018, 03:32:37 AM »

Model Number 102
Event Date 02/21/2011
Event Type  Injury   
Event Description
It was initially reported that the patient was experiencing an increase in his seizure frequency and intensity, characterized by multiple episodes of "blackouts" occurring between (b)(6) 2011. The physician attributed this increase to the generator nearing end of service; however, the diagnostics performed at the patient's appointment indicated that the device was not at end of service. The patient was scheduled for a generator replacement. Attempts for additional information from the neurologist have been unsuccessful to date. The generator was replaced on (b)(6) 2011. At that time, it was reported that the eri=yes flag had been observed. The device has not been returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155925
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dennis100
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« Reply #5 on: August 20, 2018, 03:33:34 AM »

Model Number 106
Event Date 07/26/2016
Event Type  Injury   
Event Description
Information was received on 08/22/2016 that indicated that the physician believes that the patient's blackouts are unrelated to vns therapy and likely psych related. Patient is insistent and self referred herself to a surgeon to assess lead revision but she was not referred. The patient met with the surgeon who determined there are no issues with the vns device.
 
Event Description
It was reported on 07/26/2016 from the patient that she had a replacement surgery on (b)(6) 2016. She stated that today she turned her head to the left and got a shocking sensation in her neck. The shocking is not constant and has only happened once. She also reported that she has had some blackouts that have caused her to fall down. She reported that she did fall on the device. These issues first began in (b)(6). It was reported that the physician turned the autostimulation settings from 2. 25 ma to 2. 0 ma and normal mode current is also at 2. 0 ma. She is seeing a surgeon for lead revision consult. All impedance levels are normal approximately 2900 ohms. No surgical intervention has occurred to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5889900
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dennis100
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« Reply #6 on: August 20, 2018, 03:34:27 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that a patient was experiencing blackouts, which he attributed to his vns being programmed to maximum settings. The patient could not remember if he had blackouts prior to vns. The patient stated that his surgeon informed him that vns can cause blackouts, believing that consecutive seizures coupled with maximum settings were the cause of his blackouts. The patient stated that his blackouts began two years prior. It was later reported that the physician's office had not evaluated the patient in regards to his blackouts. The nurse suggested that the blackouts could potentially be related to the patient's seizure condition, but she was unsure since the office had not evaluated the patient. No additional information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6446752
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dennis100
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« Reply #7 on: August 20, 2018, 03:35:15 AM »

Model Number 102
Event Date 01/12/2011
Event Type  Injury   
Event Description
It was reported through clinic notes dated (b)(6) 2009 that a vns pt was having more frequent seizures and went to the hospital. The patient's keppra was lowered as an intervention and as a result of the hospital visit a bladder infection was diagnosed. Further review of the notes indicated the pt had blackouts and were considered to be related to the patient's seizure nature. At the moment, the relationship of the frequent seizures to the infection is unk as good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993868
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dennis100
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« Reply #8 on: August 20, 2018, 03:36:31 AM »

Model Number 302-20
Event Date 09/14/2010
Event Type  Malfunction   
Event Description
Analysis on the generator was completed. The alleged ¿eos¿, ¿failure to program¿ and ¿no stimulation¿ events were determined to be the result of normal battery depletion. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. The electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the eos condition is an expected event. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
While reviewing internal programming history on the patient's vns generator, high impedance was noted on their normal mode diagnostic test with no corresponding system diagnostic test. Their treating physician reported that he was trying to contact the patient in regards to their high impedance but had been unsuccessful. He did not think that their vns therapy was effective therefore may not pursue further. No further information has been received in regards to their reported high impedance event.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: the previously submitted mdr inadvertently stated that the event was both an adverse event and product problem. The event is considered only a product problem. This mdr is being submitted to correct this data. Adverse event and/or product problem; corrected data: the previously submitted mdr inadvertently stated that the event was both an adverse event and product problem. The event is considered only a product problem. This mdr is being submitted to correct this data.
 
Event Description
Patient underwent generator replacement due to battery depletion and unable to interrogate on (b)(6) 2016. The lead was not replaced and the high impedance was observed with the new generator with impedance of > 10000 ohms. The explanted generator was received on 08/03/2016. Analysis is underway but has not been completed to date. Patient underwent lead revision surgery on (b)(6) 2016. The explanted lead was cut in pieces and will not be returned to manufacturer.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received for patient. Notes indicate that the patient asked the device to be turned off due to his belief that the device presented him from sleeping. The device was turned a year later from implant per notes possibly due to sleep disturbance and lack of efficacy. Patient also experienced episodes of "blackouts" starting shortly after vns being turned off. Turning on vns again was discussed with the physician. There is no evidence of even temporary device disablement per programming history. No other relevant information was received.
 
Event Description
Additional information was received stating that the vns patient¿s device was tested and system diagnostic results showed high impedance and a low battery condition. The patient¿s device was disabled but the patient subsequently began experiencing an increase in seizures. The patient declined to have his device replaced and no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information was received indicating that the event is both an adverse event and product problem.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2983415
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dennis100
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« Reply #9 on: August 20, 2018, 03:38:01 AM »

Model Number 302-20
Event Date 02/01/2012
Event Type  Malfunction   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2012 due to the high impedance. The explanted products were received by the manufacturer for analysis, however it has not occurred to date. The return product form reported that the generator was replaced prophylactically and the lead was replaced due to the electrode being off of the nerve.
 
Event Description
The implant card was received and confirmed the generator and lead replacement surgery on (b)(6) 2012. The generator was replaced prophylactically, and the lead was replaced due to the electrode being off the nerve and therefore causing the high impedance. Lead impedance following replacement was okay. Product analysis for the explanted products has not been completed to date.
 
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect date. The clinic notes received on (b)(4) 2012, indicated that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time which likely contributed to the high impedance.
 
Event Description
It was reported normal mode and systems diagnostic tests revealed high impedance. The physician's office planned on disabling the device on this day and was referring the patient for x-rays. The patient had a blackout in (b)(6) and feel on his left shoulder. He has had shoulder pain ever since, but has not felt a difference in vns stimulation. This fall may have contributed to the high impedance, per the physician. The last time diagnostics were performed on the patient's device was reportedly a year ago. The patient is likely being referred for generator and lead replacement surgery, but it has not occurred to date. Attempts for additional information have been unsuccessful to date. Film and computer a/p and lateral x-rays images of the neck and chest were reviewed by the manufacturer. It appears that one (or both) electrodes is detached from the nerve, as the positive electrode is angled at approximately a 120 degree angle from the negative electrode. It is unlikely that the patient's nerve curves in such a fashion. It appears that the positive electrode may be detached from the nerve. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is most likely related to the electrode being detached from the nerve. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out.
 
Event Description
Product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 96mm portion the quadfilar coils appeared to be stretched and kinked approximately 72mm and 92mm past the end of the electrode bifurcation. The end of quadfilar coil 1 appeared to be broken approximately 72mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. 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 portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received dated (b)(6) 2012, which again reported that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time. It was also noted that the battery is low. The patient felt that the vns was helping him prior to the device being disabled when the high impedance was first observed at (b)(6). The notes also reported that the x-rays revealed that the lead appears to be off the vagal nerve, which was reported by the manufacturer. The physician is referring the patient for generator and lead replacement surgery. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2543658
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dennis100
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« Reply #10 on: August 20, 2018, 03:38:51 AM »

Model Number 102
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the patient's seizures have gotten worse and the patient now has blackouts and questionable syncope. It has been a few years since the patient's vns has been interrogated and the physician stated that she wants the patient to get follow-up with a neurologist, but the patient cannot be seen as she has no insurance. The patient's identifying information was not provided by the physician. Attempts were made for additional information; however, they were unsuccessful. No other information has been received.
 
Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Sex, corrected data: previously submitted mdr inadvertently omitted the patient¿s gender.
 
Event Description
Additional information was received with patient identifying information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3577589
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dennis100
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« Reply #11 on: September 08, 2018, 01:16:54 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Malfunction   
Event Description
The patient reported that they are having very frequent "black outs" but is unsure if they are seizures or not. The patient has indoor cameras and when reviewed , there is no outward appearance of seizures, but it was stated that they just appear to be dead on camera, and the patient's latest blackout lasted for several days. The patient recently had a fall during one of the blackouts. The patient stated that the vns has never helped her. Additional information was received from the patient's previous neurologist who stated that they have not seen the patient since 2014, and there was no mention previously of the patient's black out events. It was stated that there is mention in the notes that the patient's vns stimulation was increased in (b)(6) 2013. It was stated that they didn't have any additional information. The patient reported that they have not seen a neurologist in over 3 years, and is currently only seeing their pcp. The patient is experiencing an increase in seizures which was described as dropping back as though dead where the patient is unconscious. The patient stated that she recently went to the er in response to one of these seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7792799
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dennis100
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« Reply #12 on: October 16, 2018, 03:21:13 PM »

Model Number 102
Event Date 05/31/2012
Event Type  Injury   
Manufacturer Narrative
Evaluation codes, corrected data: the initial report inadvertently did not report that the device was discarded in the conclusion.
 
Manufacturer Narrative

Event Description
Clinic notes were received for the patient's generator replacement surgery. The notes dated (b)(6) 2012 indicated that the patient was now experiencing brief blackouts lasting a few seconds. These are subjective and not witnessed by anybody else. She had not had any clear complex partial seizures for about 13 months, but she was still having weekly auras with about 3 per week auras. The patient's device was not interrogated on this office visit, but the previous vns settings were provided. Attempts for additional information from the patient's treating physician have been unsuccessful to date. The patient was referred for generator replacement surgery which occurred on (b)(6) 2012. Attempts for product return have been unsuccessful, as the company representative reported the implanting facility because the device was nearing end of service so the device was discarded, per hospital policy.
 
Event Description
The implant was received confirming the generator replacement surgery on (b)(6) 2012. The reason for replacement was marked as "near end of service = unknown. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2687598
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dennis100
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« Reply #13 on: October 29, 2018, 10:35:32 AM »

Model Number 102
Event Date 09/01/2012
Event Type  Injury   
Event Description
Reporter indicated the increased seizures (3 seizures) occurred the day after the patient received a depo-provera injection. The level of the seizure increase is unknown, as the patient is new to the office. An increase in vimpat medication preceded the seizure increase, but the patient's seizures now have improved with the increase in vimpat. The patient's seizures fairly well-controlled at this time, with few breakthrough seizures.
 
Manufacturer Narrative

Event Description
Reporter indicated via clinic notes received to the manufacturer that a vns patient was experiencing breakthrough seizures that may be hormonal in nature, as the seizures occurred during the patient's menstrual cycle. The seizures include blackouts. It was unclear if the vns was felt to be a cause, or stress/hormones. Vimpat medication was increased as an intervention, and the vns settings were increased. Treatment with depo-provera is recommended to prevent her hormones from fluctuating and causing seizures per the reporter. Replacement of the vns generator is likely, but is not expected to occur for several months at the patient's preference. Attempts for further information are in progress.
 
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2780787
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dennis100
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« Reply #14 on: October 31, 2018, 02:14:47 AM »

Model Number 302-20
Event Date 10/29/2012
Event Type  Malfunction   
Event Description
An implant card was received on (b)(6) 2012 indicating that the patient underwent lead and generator revision on (b)(6) 2012. Attempts for additional information and product return have been unsuccessful. The new generator was programmed on after implant.
 
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(4) 2012. The notes indicated that the patient was initially adamant that he has had not seizures or seizure-like activity and would know if he had. The patient's mother believed that he was having seizures (blacking out) but the patient was unaware. The patient eventually accepted the fact that he was having seizures. Programming history was provided. On (b)(6) 2012, diagnostic results indicated high impedance. A blc performed on (b)(4) 2012 indicated 2. 80 years remaining. Review of programming history showed that the patient's device was disabled between (b)(6) 2008 and (b)(6) 2009 for an unknown reason. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Analysis of programming history. 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=2848905
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dennis100
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« Reply #15 on: November 04, 2018, 02:00:45 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2012
Event Type  Injury   
Event Description
Follow-up to the physician¿s office regarding the blackouts and the surgeries only provided information that the patient does not want to have the device turned back on.
 
Event Description
It was reported that a patient was experiencing blackouts due to higher settings with her vns device. The device was turned off on (b)(6) 2012 as a result. It was reported the patient had to have five surgeries because of this and does not want the device turned back on. A review of the manufacturer¿s in-house programming history showed the device was within normal limits. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6261271
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« Reply #16 on: November 20, 2018, 07:38:41 AM »

Model Number 102
Event Date 01/25/2012
Event Type  Injury   
Event Description
Clinic notes were received for review in relation to this patient's generator being near end of battery life. In review it was noted that on (b)(6) 2013 "she reports 2 episodes a month, one episode is in the last week of the month, which is like an aura, which she describes as not being in control. " it was noted on (b)(6) 2012 that the patient reports episodes of thought disturbances, which she reports as a feeling of having a seizure. She says she hears that something may happen in her mind. This usually happens at the end of the month. She reports that she had a black out spell at the first of the week. A black out means that she loses consciousness, she recalls losing the consciousness, though doesn't recall anything else. She lives alone and these events are not witnessed. Good faith attempts have been made and no further information has been attained. Relationship of this black out spell to their vns is unknown. Unknown if part of the patient's usual seizure pattern.

Manufacturer Narrative
Suspect medical device - implant date - corrected data: implant date corrected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3052305
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« Reply #17 on: December 10, 2018, 03:23:41 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2018
Event Type  Malfunction   
Event Description
It was reported by the patient that he had a "slight set back"; he had 6 staring spells ("black outs" ) in the week prior after being seizure free for a while. The patient was implanted approximately a month prior to the report. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8104534
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dennis100
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« Reply #18 on: December 18, 2018, 01:08:47 PM »

Model Number 102
Event Type  Injury   
Event Description
Clinic notes were received which indicate the patient has convulsions, blackouts, and dizziness. Attempts will be made for additional information. No other information has been provided.

Event Description
Follow up with the physician found that the seizures were about the same. There was no change in severity or frequency. No vns complications. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3486103
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dennis100
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« Reply #19 on: January 04, 2019, 11:20:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the vns was causing issues for the patient. It was later reported that the patient's vns was shut off due to hoarseness, dizziness, and blacking out. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190069
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dennis100
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« Reply #20 on: January 07, 2019, 03:38:13 AM »

Model Number 103
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 note the patient has a past medical history of blackout/fainting. The relationship to vns is unknown. It is unknown when the blackout/fainting occurred. An attempt to obtain additional information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3622887
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dennis100
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« Reply #21 on: February 09, 2019, 02:14:32 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient believed she experienced issues with her vagus nerve that caused stomach pain, pain in her neck that radiates down to the chest, migraines, and black out spells. The company representative indicated that the patient's generator system diagnostics were within normal limits. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8224067
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dennis100
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« Reply #22 on: February 09, 2019, 02:16:02 AM »

Model Number 102
Event Date 08/21/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received when the physician reported that no causal or contributory programming or medication changes precede the onset of the syncope and dizziness. The patient was seen by a cardiologist and diagnosed with neurocardiogenic syncope. The physician stated that there is no relationship between the patient¿s vns and the syncope and dizziness.
 
Event Description
It was reported that the patient began having black out spells and dizziness. A nuclear stress test was performed and was within normal limits. An echocardiogram was done which showed his ejection fraction has decreased and then the patient was placed on a holter monitoring device to record heart activity with the events. The patient will be monitored for a month. The dizziness and blackout spell were happening everyday several times per day and was not associated with a time or day nor with any body positioning (standing or rising, or sitting). The cardiologist of the patient believes it is related to vns and he turned the stimulation down. It was believed that this helped with the events but the patient was still experiencing symptoms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210094
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dennis100
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« Reply #23 on: February 11, 2019, 02:34:35 AM »

Model Number 103
Event Date 01/06/2015
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
 
Event Description
Additional information was received that the patient's reported episode is not a new seizure type, unknown cause for episode (drop attack with lips turning blue). No interventions were taken. Medications taking at the time of the event. Depakote-6. 25 mg bid / fycompa 8 mg qhs / zonisamide-150 mg qhs / banzel 17. 5 ml in am, 3. 5 ml in afternoon , 7 ml evening / onfi-5 mg bid.
 
Event Description
It was reported that the vns patient experienced a drop attack and blacked out following a magnet swipe. It was noted that this seizure type was not typical for the patient. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4483657
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dennis100
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« Reply #24 on: March 07, 2019, 02:05:15 AM »

Model Number 302-20
Device Problems High impedance; Unexpected Therapeutic Results
Event Date 07/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient had experienced an increase in seizures over the past two months. Interrogation and diagnostics of the vns device showed high impedance results. No known trauma was reported to have occurred. Patient is referred for a full revision of the generator and lead as a result. Clinic notes were received stating that the patient's seizures have increased. Patient was also reported to be blacking out with seizures and is no longer able to hear during the seizures. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent full revision surgery on (b)(6) 2015. Attempts were made for the return of the explanted lead and generator but only the generator was received on (b)(6) 2015. Analysis is underway but has not been completed.
 
Event Description
Analysis was completed on the returned generator and the generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5111738
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dennis100
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« Reply #25 on: March 27, 2019, 01:40:22 AM »

Model Number 103
Event Date 01/12/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's vns battery is "shutting down". Additional information was received that the patient's battery was seen to be low (about 10%). Also, the patient has started having seizures a few weeks prior to visit on (b)(6) 2015 after previously being seizure free. These new seizures are also of a different type than previously, a "black-out seizure" where the patient does not recall events surrounding the black out and 3-4 hours afterwards. Furthermore, it was reported that when swiping the magnet the patient does not feel the magnet stimulation. No additional relevant information has been obtained to date.
 
Event Description
An implant card was received indicating that the patient underwent prophylactic generator replacement. It was reported that the explanted generator was discarded by the explanting facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5339671
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dennis100
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« Reply #26 on: April 17, 2019, 07:12:45 AM »

Model Number 103
Event Date 01/07/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It patient reported that she had been experiencing episodes of blacking out since her previous vns replacement. The patient's last known treating physician had reported that they do not have information to offer on the patient's reported symptom. The patient's implant card from her previous vns surgery showed that impedance was within normal limits at the time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5956355
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dennis100
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« Reply #27 on: July 26, 2019, 01:29:51 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Initial report was a text message received stating the following: "i need help with replacing battery it's at 8% they're having black outs. " further information was received indicating that the patient underwent generator replacement. The explanted generator has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8291242
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