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dennis100
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« Reply #30 on: May 21, 2017, 01:51:36 PM »

Model Number 102
Event Date 11/08/2007
Event Type  Injury   
Event Description 
On (b)(6) 2013 the physician¿s nurse stated that the vns was not working for this patient, the patient just never got better. The patient had severe side effects and just had a really rough time with vns. The patient¿s depression didn¿t get better. The nurse stated that she thinks it is related to his underlying illness, being treatment resistant. She also mentioned that he has a history of suicidal thoughts ongoing and some suicidal gestures. She mentioned that he started or continued to have suicidal thoughts very shortly after he was implanted and the vns was turned on. She said she thinks it was because he thought the vns was going to work for him and it didn¿t. The nurse stated that she looked over the patient¿s progress reports and she saw where the device was turned on at 5. 5 weeks and the patient didn¿t feel that his mood had changed. The patient was still feeling depressed and having a lot of side effects.
 
Event Description 
On (b)(6) 2013, it was reported that the vns patient had to have the vns turned off due to severe side effects and he was still depressed. It was previously reported on (b)(6) 2007 that the patient has made suicidal gestures. Further follow up with the physician revealed that the gestures were not related to vns therapy. Additionally, the patient's treating medical professional indicated that patient was experiencing vomiting, nausea, dyspepsia and headache on (b)(6) 2008. The medical professional has stated that all these events can be related to vns. Even though the patient has had medical history of these problems, they appeared to be worsened with vns stimulation. An additional event of cognitive changes where the patient was entering dream states was reported. Follow up with the treating medical professional revealed that the event is believed not to be related to vns therapy, but likely related to the patient's underlying psychiatric condition. The patient is reportedly doing better with emotional freedom exercises and they are considering putting the patient on an anti-psychotic. An additional report was received that this patient is experiencing side effects from vns including difficulty breathing, migraine, photophobia, nausea, indigestion, and reflux. Good faith attempts were made for additional information, but were unsuccessful. Even though a response was not received regarding diagnostics results, investigation of a report of cognitive changes showed the device to be functioning properly on (b)(6) 2008. No additional information was received regarding the dyspnea and visual disturbances events. Additional information from the site indicated that diagnostics on (b)(6) 2008 showed the device to be functioning properly. The physician indicated that all events except migraines were present from the first stimulation. The migraines and photophobia events began after the output current was increased. The dyspnea and dyspepsia events are associated with stimulation on times. It appears the patient had reflux 10 years ago, and the gi symptoms reappeared with vns therapy. It appears that the cognitive changes had disappeared, and then recurred about 2-3 times in one week. An additional contributing factor to the migraines and photophobia is the patient's hypertension. Decreasing the pulsewidth has seemed to help these events. Medication is being administered for the dyspepsia and migraine events. The patient is still undergoing relaxation techniques and therapy. The programming history database was searched. The patient was last programmed to output=1. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. The last system diagnostics test was from (b)(6) 2009 which showed output=ok/lead impedance=ok/dcdc=3/eri=no. On (b)(6) 2012 a nurse stated that the patient's output current was increased from 1. 75 to 2. 25, signal frequency decreased from 30 to 25, and off time was increased on (b)(6) 2011. The patient's side effects then became intolerable. On (b)(6) 2011, they turned the device completely off after the patient had turned it off with his magnet for a trial period from (b)(6) 2011. The patient still has the device turned off at present and the patient has since felt better. Additional information was received on when a form dated (b)(6) 2011 from the physician stated that the patient's reflux/indigestion and migraines resolved after turning off the vns. The physician later reported that the lack of efficacy was first observed on (b)(6) 2007. The patient was noted to have severe refractory depression that has been and continues to be non-responsive to therapy, medications, and vns.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118167
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dennis100
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« Reply #31 on: May 21, 2017, 01:53:56 PM »

Event Date 02/19/2008
Event Type  Malfunction   
Event Description 
Reporter indicated a vns patient presented at an office visit with high lead impedance. The physician also indicated the pt has not received any benefit from the vns therapy system. X-rays were taken and sent to the manufacturer for review. A gross lead fracture was visualized prior to the lead bifurcation. Follow-up with the physician revealed the pt has no axial body tone and cannot sit up. The pt is constantly falling over in her chair and the falls are bad. The physician believes one of the falls could have caused or contributed to the lead break. The physician also believes the lack of efficacy is due to the pt not receiving therapy because of the lead fracture. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative 
Patient identifier, corrected data: the initial report inadvertently did not report this information. Dave of event, corrected data: the initial report inadvertently reported the date incorrectly. Suspect device implant date, corrected data: the initial report inadvertently did not report the date.
 
Event Description 
Additional information was later received from the np who saw the patient in the clinic on (b)(6) 2012. The patient will be explanted (with no specific date known yet) due to patient not responding. The np again reported that the patient's vns was turned off a while ago, and the mother does not want the patient implanted anymore. Attempts for product information have been unsuccessful to date. Although explant surgery is likely, it has not occurred to date.
 
Event Description 
Additional information was received from the company representative reporting that the patient's treating neurologist informed the surgeon in a letter that the patient had not experienced any significant change in seizures using either vns or medication. (although, it is previously known that the device was turned off on (b)(6) 2008. ) the letter also stated that the seizures have not gotten worse, and that the patient was discontinued off of medications. The patient is autistic and keeps grabbing at her generator and the mother would rather have the entire vns system out. At this time, it appears that the patient will have a generator and lead explant, however it has not occurred to date. Clinic notes dated (b)(6) 2012, were received from the referring neurologist's office which reported that the request to have her vns removed was furnished previously bus has not been acted on by her mother. She is currently on no medications having self-discontinued her medications. Her mother states that she has tremors throughout the day and drop attacks with inconsistent history stating occasionally four per week or four per day. The mother requests return to medication because she feels the patent has had some effect in the past.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015917
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dennis100
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« Reply #32 on: May 21, 2017, 01:55:05 PM »

Model Number 102
Event Date 01/01/2006
Event Type  Injury   
Event Description 
It was reported that a vns pt's device had been disabled due to lack of efficacy and that the event was believed to be due to the pt's progressive dementia. The pt's clinic notes were received, which described events of worsening depression, increased anxiety, suicidal ideations and events of dyspnea, two of which led to emergency room admission, while receiving vns therapy. The clinic notes indicate that the pt's pre-vns medical history was significant for each of these events, though their relationship to the pre-vns baseline is unk. Diagnostics performed on the pt's device prior to device disablement indicated proper device function. The clinic notes also state that many of these events were proceeded by and related to medication changes and adjustments. The pt's treating vns therapy physician does indicate in these notes that "my impression is pt is slightly better than at start of study, moderately ill. " good faith attempts for additional info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1321655
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dennis100
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« Reply #33 on: May 21, 2017, 01:58:51 PM »

Model Number 103
Event Date 12/27/2013
Event Type  Injury   
Event Description 
The patient reported that she can see the lead protruding under her skin when she bends over. It was reported that the patient underwent generator replacement on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative 

Event Description 
On (b)(6) 2013, this patient reported that something was not right with her device. The patient went to the emergency room on (b)(6) 2014. The patient had bad bruising, and x-rays were taken which reportedly showed no wire (lead) issue. The device was not going off every five minutes as it was supposed to. The device was reportedly randomly giving ¿double doses¿ (magnet mode stimulation) and was causing pain. On (b)(6) 2013, an er physician reported that the patient was complaining of shocking at the battery site. On (b)(6) 2013, the patient reported an increase in seizures since being implanted in (b)(6) 2013. Per the patient¿s stepfather, the device was malfunctioning, constantly shocking, and could not be turned off. Clinic notes dated (b)(6) 2014 indicated that the patient had a vns placed on (b)(6) 2013 and had no benefit from it. [clinic notes dated (b)(6) 2013 (prior to vns implant) indicate the patient had six seizures in the last two months. ] the device began to be dysfunctional on (b)(6) 2013. The patient felt like she had a tens unit in her chest. She felt the shocking at the generator site, not the electrode site. The patient felt like the generator had fallen down and to the left. The patient¿s mother felt a buzzing when she touched the patient¿s chest. The patient was seen in the er for this and a bloody nose. Per the patient¿s mother, the patient was having double seizures: a gtc seizure followed by another one a few minutes later. This happened three times since the device began to malfunction. At a previous visit, the device was programmed off, but the symptoms persisted. Give the patient¿s history of psychiatric overlay, it was unclear if this was an actual dysfunction of the device or another manifestation of psychiatric diagnostic. On (b)(6) 2013, it was reported that the patient¿s device was disabled on (b)(6) 2014 due to the shocking sensations; however, it was also reported that it was disabled due to random activations reported in manufacturer report number: 1644487-2013-03481. On (b)(6) 2013, it was reported that the generator had migrated. It was also reported that this vns patient was beaten by her ex-boyfriend. Since that time, the generator has migrated, and she has been feeling ¿shocking¿ sensations with stimulation. Per the patient, the physician could not disable the device; however, it was confirmed the device was disabled. On (b)(6) 2014, it was reported that the patient¿s device was disabled but was still shocking her. The patient was only titrated up one time since implant, which is likely the reason for lack of efficacy. The patient was referred for an eeg. There was no high lead impedance. Clinic notes dated (b)(6) 2014 were received which indicate that around christmas, the patient was beaten up by her boyfriend at the time. Per the notes, the patient was beat so severely that she has had trouble with the vns since. The patient says the generator will shock her at times and there has been difficulty turning the device off. The notes state the incisions appear to be well healed and there is no evidence of infection. The generator does not appear to be off and does not appear to have any gross malfunction to it. However, when the patient swipes the magnet she experiences coughing as well as a change in her voice. The generator was interrogated again and seen to be turned off, so the physician states that it is unclear what is happening, but the patient is experiencing symptoms. The physician states that they will keep the device off for now, and consider replacing the generator. Surgery is likely, but has not occurred to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3597907
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dennis100
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« Reply #34 on: May 21, 2017, 02:00:42 PM »

Model Number 102
Event Date 11/01/2010
Event Type  Injury   
Event Description 
It was reported by a vns pt that she felt fast heartbeat in her chest, tightening in throat, difficulty breathing, and nausea when coming within 5-10 feet of a family member who had a pacemaker. Per manufacturer's labeling, pacemakers are not expected to affect the operation of vns system; however, it is recommended to keep a distance of 4 inches or 10 cm to avoid any interruption. The pt also stated that by holding her magnet over the vns device, the generator was disabled and her symptoms were alleviated. She was also concerned that the device may be malfunctioning due to trauma she experiences during her grand mal seizures; i. E. She falls down during her grand mal seizures. Lastly, pt complained about lack of efficacy of device that vns device has never stopped a seizure for her. Further follow up with the pt treating neurologist revealed that pt hasn't been seen since these adverse events were reported to the manufacturer. 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=1961088
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dennis100
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« Reply #35 on: May 21, 2017, 02:02:28 PM »

Model Number 102
Event Date 05/23/2005
Event Type  Malfunction   
Manufacturer Narrative 
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Manufacturer Narrative 
Analysis of programming history.
 
Event Description 
Product analysis was approved on (b)(6) 2013 for this explanted generator. The device was explanted on (b)(6) 2012 due to lack of efficacy. An end of service (eos) condition was found in the pa laboratory. The supply current tests did not meet functional specifications. These measurements demonstrate an increased current consumption for the device, potentially contributing to end-of-service (eos) condition. A battery life estimation resulted in 1. 12 years remaining before the near-end-of-service (neos) flag would be set. However, an incomplete programming history (1. 5-year gap) indicates the estimation does not use all the data required to make an accurate estimation. The increased current consumption was isolated to a leaky capacitor (c6). With the capacitor substitution for c6, the pulse generator module performed according to functional specifications. The most probable root cause for the end-of-service (eos) condition was identified to be a leaky capacitor (c6). Cause for the capacitors (c6) increase in leakage could not be determined.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966077
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dennis100
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« Reply #36 on: May 21, 2017, 02:03:39 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type Malfunction
Manufacturer Narrative
Murray, diana & yerby, m. "efficacy of vagal nerve stimulation on selected pts with intractable epilepsy. ".

Event Description
It was reported a vns therapy pt did not receive any benefit from vns therapy. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810669
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dennis100
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« Reply #37 on: May 21, 2017, 02:05:07 PM »

Model Number 102
Event Date 04/12/2012
Event Type  Injury   
Event Description 
A vns patient reported that she wants her device removed due to lack of efficacy and also due to a medical issue in her left breast that requires mammograms. The patient reported that with the vns and mammograms they were having difficulty visualizing the area so wants device removed. No further information available aside from the fact that patient has not seen a provider in multiple years for their vns. The patient has not been to see the surgeon whose name we provided for follow up therefore no further information can be attained about the reported event till the patient is evaluated. It is unknown the relationship of their left breast issue to their vns.
 
Manufacturer Narrative 
(b)(4).
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2564562
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dennis100
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« Reply #38 on: May 23, 2017, 01:13:57 AM »

Model Number 302
Event Date 06/01/2007
Event Type  Injury   
Event Description 
Since i was implanted with cyberonics, inc vagus nerve stimulator in 2007, i have suffered a series of adverse reactions. These included: weight loss over a 2 month period- requiring 2 hospitalizations for dehydration -due to anorexia and abdominal pain-; severe left ear pain requiring visits to my ent and subsequent lowering of the strength of stimulation; severe shortness of breath accompanied by airway constriction, and low blood oxygen levels requiring evaluation by a pulmonologist, pulmonary function studies, and a cat scan; sleep hypopnea demonstrated by polysomnogram and a choking sensation. I must use the magnet provided by cyberonics inc at least 75% of the time. The stimulator, which was implanted for trd, never seemed to relieve my depression. Dates of use: 2007 - 2008. Diagnosis or reason for use: trd. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1033973
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dennis100
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« Reply #39 on: May 23, 2017, 01:15:34 AM »

Model Number 102
Event Date 02/01/2008
Event Type  Malfunction   
Event Description 
It was reported to manufacturer that the vns patient was seeking to have the device explanted as she reported lack of efficacy with the device, and there is a need for an mri. Further follow up with the treating physician revealed that the patient had one week that was notable "free from depression" about a few months after vns therapy began. But over time, the patient never had a notably positive response to vns. The patient is seeking to have an mri for other conditions not related to vns and since considered a treatment failure, the patient is requesting to have the device removed. The physician stated that the patient was considered a good vns candidate, however ended up a non-responder. Additionally, several setting changes were made to attempt to achieve efficacy. The physician stated that diagnostics were never performed during the time of implant to confirm proper device function. The implant card was reviewed and the lead impedance was marked ok indicating normal function at time of implant. Due to lack of recent diagnostics, a device deficiency cannot be ruled out as a contributory factor to the lack of efficacy, therefore no conclusion can be drawn. Explant surgery is likely.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1029527
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dennis100
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« Reply #40 on: May 23, 2017, 01:16:44 AM »

Model Number 102
Event Date 04/01/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that a vns pt was explanted due to a lack of efficacy. Follow up with the treating physician revealed that the pt's lack of efficacy was due to non-compliance with medications, intermittent follow-up and an inability to achieve a therapeutic level of stimulation due to dysphagia. Device diagnostics were not performed. The explanted lead and generator were received and are currently awaiting 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=1034821
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dennis100
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« Reply #41 on: May 23, 2017, 01:17:49 AM »

Model Number 101
Event Date 11/01/2006
Event Type  Malfunction   
Manufacturer Narrative 
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
Reporter indicated a pt had lack of efficacy. The vns generator and lead were explanted. No new vns devices were implanted. The explant date is unk. The explanted generator and lead have been returned and are currently in product analysis. Further attempts for info regarding the lack of efficacy are in progress.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1028713
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dennis100
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« Reply #42 on: May 23, 2017, 01:39:06 AM »

Event Date 12/01/2008
Event Type  Injury   
Event Description 
It was reported that explant surgeries were performed on patients due to the following reasons - persistent breathing, coughing, throat discomfort associated with lack of efficacy and parental request.
 
Manufacturer Narrative 
Pearl pl, conry ja, yaun a, taylor jl, heffron am, sigman m, tsuchida tn, elling nj, bruce da gaillard wd. Misidentification of vagus nerve stimulator for intravenous access and other major adverse events. Pediatr neurol 2008;38:248-251.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1034246
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dennis100
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« Reply #43 on: May 24, 2017, 01:45:06 AM »

Model Number 100
Event Date 04/11/2008
Event Type  Malfunction   
Manufacturer Narrative 
A device malfunction cannot be ruled out, but event did not cause or contribute to a death or serious injury.
 
Event Description 
Initial reporter indicated that they had their vns explanted for lack of efficacy. Further information was attained from the patient's treating physician that the patient "probably did not" have efficacy. Setting changes were attempted to gain efficacy. No device diagnostics were provided by site to rule out a device malfunction. The device was disabled in 2001. The explanted generator is at manufacturer pending completion of product analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1041280
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dennis100
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« Reply #44 on: May 24, 2017, 01:46:15 AM »

Model Number 102
Event Date 01/01/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that pt had her generator and lead explanted due to lack of efficacy. Manufacturer review of programming history database revealed that high lead impedance was obtained during diagnostic testing on this patient's device. Explanted lead and generator were subsequently returned to mfr for product analysis. During this analysis, malfunctions were identified with either returned product; however, it was noted by impressions on the lead pin that it was not fully inserted into the header of the generator. The lead pin not being fully inserted is the most probable cause for the high impedance and could have been a contributing factor to the lack of efficacy event.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047730
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« Reply #45 on: May 24, 2017, 01:47:24 AM »

Model Number 102
Event Date 01/22/2006
Event Type  Injury   
Event Description
It was reported to manufacturer that the vns pt had experienced a worsening of the seizure disorder and the physician had attributed the worsening to nvs therapy. The physician had attempted multiple setting changes in an attempt to obtain efficacy with the device, however, they were unsuccessful. The device was subsequently disabled, and the patient's seizures are currently being controlled with a medication regimen. The pt had a surgical consult to have the device removed. Subsequently, surgery occurred where a portion of the lead and generator were removed and returned to manufacturer for analysis. Analysis is currently underway. Device diagnostics were performed at the explant surgery and revealed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1329155
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dennis100
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« Reply #46 on: May 24, 2017, 01:48:32 AM »

Model Number 102
Event Date 11/12/2007
Event Type  Injury   
Manufacturer Narrative 
Device malfunction is suspected, but did not cause a death.
 
Event Description 
Reporter indicated a vns patient is scheduled to have the entire system removed because of vns "never worked and that it had always been uncomfortable. " the vns was turned off around the second week for an increase in seizures, throat discomfort and hoarseness. The pt's seizure activity level prior to being implanted with vns is unknown. 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=1025155
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« Reply #47 on: May 24, 2017, 01:49:37 AM »

Model Number 102
Event Date 01/01/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that pt had her vns therapy generator and lead explanted due to lack of efficacy. Device diagnostic results are not available to mfr at this time, so a malfunction cannot be ruled out. Explanted products were returned to mfr for analysis, however, that analysis is not yet completed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025479
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« Reply #48 on: May 24, 2017, 10:52:02 PM »

Model Number 103
Event Date 01/01/2009
Event Type  Death   
Event Description 
The reporter indicated that a vns pt had recently passed away and that his vns device had been explanted and disposed of prior to burial. Follow up with the pt's treating vns therapy physician revealed that the pt's device had been disabled due to lack of efficacy prior to the report and that device diagnostics at the time had confirmed proper device function. The circumstances of death and the relationship to vns is unknown. Good faith attempt for additional information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1362666
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« Reply #49 on: May 24, 2017, 10:53:10 PM »

Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description 
Reporter indicated that during an explant procedure, for a lack of efficacy, the device registered high impedance. The device was successfully explanted, and once removed, a slit was noted in the insulation of the lead. Attempts for more information, and to have the device returned for analysis have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1420035
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« Reply #50 on: May 24, 2017, 10:54:23 PM »

Model Number 100
Event Date 11/19/2007
Event Type  Malfunction   
Event Description 
Initial reporter indicated that they "heard a clicking sound coming from her son's throat and wanted to know if it was the vns device. " the pt's mother additionally reported that "her son coughs a lot and has a lot of saliva. " she then stated "in my opinion the vns device has not worked for her son's seizures, and she is considering having it removed. " good faith attempts are being made for more info surrounding the reported events. Device malfunction cannot be ruled out without diagnostic info.
 
Manufacturer Narrative 
Device malfunction 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=965901
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« Reply #51 on: May 24, 2017, 10:55:35 PM »

Model Number 302-20
Event Date 12/04/2012
Event Type  Injury   
Manufacturer Narrative 

Event Description 
A patient implanted with a vns device called and reported that he is most likely going to have his device removed in the near future. He stated that he had nothing against the company, but that vns just 'never really worked for him'. The patient later called and reported that their lead wire was protruding and they were having neck spasms. Their device has been turned off and he will be seeing his surgeon for a consult to have device removed. No surgery date has been set at this time.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2886943
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« Reply #52 on: May 24, 2017, 10:57:08 PM »

Model Number 102
Event Date 07/30/2013
Event Type  Injury   
Manufacturer Narrative 
The lead analysis results were inadvertently left off of the initial mfr. Report.
 
Event Description 
Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative 

Event Description 
It was reported that the patient had the vns device explanted because it was implanted for seven years and never worked, and now the patient is having breathing problems, or dysphagia, with vns. The explanted device was returned on (b)(4) 2013 and is pending product analysis. Attempts will be performed for additional information. No additional information has been received.
 
Event Description 
Analysis of the lead was completed on (b)(6) 2013. Note that the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer and connector pin inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and connector pin inner silicone tubing. 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 pin 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 generator analysis was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results 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. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3313844
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dennis100
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« Reply #53 on: May 24, 2017, 10:58:15 PM »

Model Number 102
Event Date 01/26/2011
Event Type  Injury   
Event Description 
It was reported by a vns depression patient that vns had never worked for him and caused him nothing but problems from inability to talk, hoarseness, and chest pain. Further information from the patient indicated that the would like to have his vagus nerve stimulator removed because he does not feel vns has helped him. The patient is no longer seeing his treating psychiatrist and was provided with the name of another physician but patient says he is unable to travel to the physician. Good faith attempts to obtain additional information from the previous psychiatrist regarding the reported events by the patient have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005793
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« Reply #54 on: May 24, 2017, 10:59:32 PM »

Model Number 302-20
Event Date 01/01/2005
Event Type  Malfunction   
Manufacturer Narrative 
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported the patient was having their vns explanted for lack of efficacy. Internal search of programming history data showed the patient to have high lead impedance on a system diagnostics test dated (b) (6) 2005. The patient's vns was programmed off on (b) (6) 2007 and explanted in 2009 for lack of efficacy. Good faith attempts have been made for additional details surrounding the event. An analysis was performed on the returned lead. Note that the lead assembly (body) including the section of the connector boot containing the model and serial number tag and the electrode section were not returned; therefore, it was not possible to verify the model and serial number during this analysis and a complete evaluation 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. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were not performed, during the visual analysis, because the quadfilar coils were not returned. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. There were no performance or any other type of adverse conditions found with the pulse generator. The pulse generator performed according to specifications.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1426995
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« Reply #55 on: May 24, 2017, 11:01:07 PM »

Model Number 100
Event Date 02/14/2006
Event Type  Injury   
Event Description
It was reported that the patient's device was explanted on (b)(6) 2006, at the time it was indicated that the device was explanted due to a lack of efficacy. Clinic notes were received on (b)(6) 2012 which indicated that the device was actually explanted due to an infection. Attempts for additional information have been unsuccessful as it was indicated that no additional information was available. The device history records for the patient's vns devices were reviewed. Sterilization was confirmed prior to shipment.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2508207
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« Reply #56 on: May 25, 2017, 12:44:17 AM »

Event Date 06/13/2006
Event Type  Injury   
Event Description 
It was reported in an article following pediatric patients that were implanted with vns, that a patient with right hemisphere epilepsy experienced excessive drooling and aspiration pneumonia on higher current settings, which were resolved with lowering the current intensity. The patient's device was turned off 42 months after implantation due to lack of clinical benefit. There is no allegation of device malfunction. Good faith attempts to obtain additional information from the author of the article have been unsuccessful to date.
 
Manufacturer Narrative 
Article: long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Alexopoulos, a. Et al. Seizure 2006 pp. 1-13. See scanned pages.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1303637
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« Reply #57 on: May 27, 2017, 01:52:07 AM »

Model Number 300-20
Event Date 01/24/2008
Event Type  Malfunction   
Event Description 
Initial reporter indicated that the patient had their vns explanted for lack of efficacy. During review of programming history, it was noted during one visit the patient had high lead impedance on one systems test and then two consecutive tests after at the same visit were within normal limits. The explanted product is at manufacturer pending completion of product analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1446663
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dennis100
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« Reply #58 on: May 28, 2017, 01:47:51 AM »

Model Number 300-20
Event Date 01/01/2002
Event Type  Malfunction   
Manufacturer Narrative 
Only a portion of the lead was returned for analysis, which did not reveal any anomalies. The exact cause of the high lead impedance is unknown.
 
Event Description 
It was indicated in a review of programming history of a patient's programming history that there was high lead impedance from 2002 through 2003, which was resolved on or before 2004. It is unknown at this time, what caused or may have contributed to the high lead impedance. It is unknown what resolved the high lead impedance. Device was returned to manufacturer following explant of lead and generator, due to lack of efficacy. Product analysis resulted in no observed anomalies on the portion of the lead returned. Three sets of setscrew marks were seen in each connector pin, thus providing evidence the proper contact between the setscrew and the lead pin existed at least once. Product analysis of generator resulted in no observed anomalies and device performed within specifications. 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=1431132
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« Reply #59 on: May 28, 2017, 01:49:13 AM »

Model Number 101
Event Date 01/01/2009
Event Type  Injury   
Event Description 
It was reported to manufacturer that the vns pt had surgery where the lead and generator were explanted, due to lack of efficacy and the generator had "migrated down the chest wall to the breast". Attempts to obtain additional info from both the surgeon and treating physician have been made, but have been unsuccessful to date. The explanted lead and generator have been returned to manufacturer and analysis is underway.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386064
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