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dennis100
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« Reply #30 on: June 06, 2011, 02:09:27 AM »

Event Date 08/01/2002
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt has lost their voice and is not able to speak following vns implant surgery. Investigation to date has been unable to determine whether the pt has been diagnosed with vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418094
« Last Edit: October 01, 2015, 06:41:57 AM by dennis100 » Logged
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« Reply #31 on: July 07, 2011, 01:49:35 AM »

Event Date 02/23/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
As mentioned previously on mfr report #1644487-2011-00865, the vns pt was said to have vocal cord dysfunction (vcd) recently by her physician. The pt's surgeon treated the pt's vcd by radiesse injections to the vocal cord, and now her voice is doing "much better. " add'l info was rec'd that stated the vcd had occurred at the time of the implant surgery in 2009 and it was not related to stimulation. The left vocal cord had been affected by the vcd, no medication changes preceded the vcd, and the pt did not have a history of the event prior to vns. The pt's neurologist, however, had been contacted after implantation regarding a report of the pt's losing her voice - he stated the event had not been related to vns. All other investigational findings will be covered in the above mentioned mfr report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133433
« Last Edit: October 01, 2015, 06:42:10 AM by dennis100 » Logged
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« Reply #32 on: August 08, 2011, 12:46:45 AM »

Event Date 11/01/2006
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that their child's generator had migrated and that their child had a "lump on their neck the size of an olive" after a "bad seizure" reportedly, the patient did not resume speaking after this seizure for four days. Reporter also indicated that there is not an increase in seizure activity since vns. The patient's treating physician stated "the vns device moves and causes pain when lift left arm. " in addition, he stated that "the patient feels the generator is moving-i cannot see this clinically" and "she is now hoarse-clinically seems to have superior laryngeal nerve palsy-perhaps nerve injured during a seizure as symptoms started after a prolonged strong seizure. " attempts have been made to obtain device diagnostics to confirm proper device functioning. Good faith attempts have been made and no additional information received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=892209
« Last Edit: October 01, 2015, 06:42:31 AM by dennis100 » Logged
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« Reply #33 on: August 08, 2011, 12:47:18 AM »

Event Date 06/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns pt had developed laryngeal edema. It was reported that initial interrogation at an office visit indicated that the vns generator was set at a duty cycle of 30 seconds on and 0. 5 minutes off. It was also reported that the pt had been continuously swiping his magnet to initiate magnet mode stimulation. The physician changed the off time to 5 minutes in response to the event. No other treatments or actions were reported. It had been previously reported that the pt also experienced dyspnea, voice alteration, and painful stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=896345
« Last Edit: October 01, 2015, 06:42:57 AM by dennis100 » Logged
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« Reply #34 on: August 08, 2011, 12:47:45 AM »

Event Date 04/07/2011
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was initially reported by a physician that a pt was having laryngeal spasms, which had required her hospitalization in the past. At this time, the pt had 3 spasms and the pt turned cyanotic. The pt's vns physician turned the output current down from 2. 5 ma to 2. 0 ma, stopping the spasms. The pt was reported to be "doing better" after the change in parameters. Further info was received from the physician, which stated the spasms did correlate with the vns stimulation, but the pt "was having other issues going on, too". Consequently, it was difficult for the physician to say what was causing the effect exactly. Diagnostic results were not available from the site, there were no other factors that could have contributed to the event, and the pt did not have a history of this event prior to vns. However, the site then claimed the relationship to vns for this event was not known. The site claimed that the pt's mother was going to "see what happens" at the lowered setting and re-evaluate at a later time. A search of the mfr's programming history database revealed that last known diagnostics on (b)(6) 2011 were within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098645
« Last Edit: October 01, 2015, 06:43:20 AM by dennis100 » Logged
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« Reply #35 on: August 08, 2011, 12:48:12 AM »

Event Date 03/08/2006
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the patient was experiencing laryngeal spasms, and had also deveoped an infection at the generator site. The vns therapy system was explanted due to both the infection and laryngeal spasm. Propr to explant, stimulation was temporarily discontinued, after which the laryngeal spasms did not resolve. The patient's condition has reportedly imporved after explant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=730353
« Last Edit: October 01, 2015, 06:43:46 AM by dennis100 » Logged
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« Reply #36 on: August 08, 2011, 12:49:53 AM »

Event Date 07/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt has had trouble speaking since implant and has since been told that there may be a problem with a laryngeal nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=346398
« Last Edit: October 01, 2015, 06:44:20 AM by dennis100 » Logged
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« Reply #37 on: August 10, 2012, 01:42:11 AM »

Event Date 05/29/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
On (b)(4) 2012, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2010 revealed that the patient was experiencing dysphagia as well as dysphonia due to vns and uvulopalatopharyngoplasty. The physician further states that the patient needs battery replacement and that vns is most likely contributing to the dysphonia. The patient was also noted to have obstructive sleep apnea (previously reported on mfr. Report number 1644487-2012-01665). Good faith attempts for further information from the physician have been made but no additional information has been received to date. Attempts for product information cannot be made to the implanting facility as it is unknown where the patient was implanted.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when it was reported that the reason for the generator replacement referral was either for end of service or near end of service. The patient underwent a full revision surgery on (b)(6), 2012 and it was confirmed that the generator was replaced due to eos=yes. The leads were also replaced due to high impedance being observed during surgery. The consultant who attended the surgery indicated that he ran multiple diagnostics tests on the day of surgery and high impedance was observed on each occasion. The consultant stated that he had not performed diagnostics on this patient prior to the surgery. The consultant stated that the hospital would not give him the explanted products to return for product analysis. Attempts for further information from the physician have been made but were unsuccessful.
 
Manufacturer Narrative
Product problem (e. G. Defects/malfunctions); corrected data: inadvertently did not check "product problem" on supplemental report #1.
 
Event Description
Additional information was received on (b)(6) 2012, when the implant card was received indicating the patient's generator product information. The lead impedance after replacement was noted to be within normal limits. A battery life calculation was performed which showed a negative amount of time remaining until near end of service.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2637228
« Last Edit: October 01, 2015, 06:45:06 AM by dennis100 » Logged
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« Reply #38 on: September 07, 2012, 07:38:24 AM »

Model Number 102
Event Date 08/01/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported through clinic notes received on (b)(4) 2012 and dated (b)(6) 2012 that the patient was seen in the office as he had started experiencing a "surge" with his device. The patient had not experienced any breakthrough seizures however he had been experiencing discomfort in his neck as well as increased dysphonia. The patient also reported that he felt as if he was swiping his magnet although he had not been. The generator was checked and was said to be working well with a reported dc/dc of 3 on magnet mode diagnostics. Per the physician, the case was reviewed with a manufacturer's representative at the time of the report. The physician felt that, due to the patient's clinical symptoms and length of implant, the battery may be failing. The patient has since been referred for a generator replacement. No additional information is known at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2721914
« Last Edit: October 01, 2015, 06:45:28 AM by dennis100 » Logged
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« Reply #39 on: September 07, 2012, 07:39:05 AM »

Model Number 304-20
Event Date 07/15/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
On (b)(6) 2012, a physician stated that a recently implanted vns patient's lead was too tight and would need to be revised. (a 2. 0 mm lead was initially implanted). On this date, the patient's surgeon reported that this vns patient was recently implanted and had hoarseness. The patient's device had not been turned on. The patient's mother initially reported that the patient was experiencing a hoarse voice after implant surgery on (b)(6), 2012. Therapy had not been started, yet. The hoarse voice began five days after surgery. The patient's voice was described as hoarse and raspy. On (b)(6) 2012, follow up with a manufacturer's consultant revealed that at the time of surgery, the lead was a 'little snug' upon implant; however, the implant was still performed. Aside from this, the procedure was atraumatic. Four days later, the patient began have hoarse voice that progressively got worse. The patient's mother told the manufacturer's consultant that the surgeon performed a laryngoscopy on (b)(6), 2012 and reportedly saw something that made him think the cause was the lead size; therefore, surgery was performed on (b)(6), 2012. Follow up with the surgeon was performed on (b)(6), 2012. He reported that he saw vocal cord paralysis during the laryngoscopy on (b)(6), 2012. He had thought that the lead was a little snug but not outrageously so. He planned to replace the lead with a 3. 00 mm lead on (b)(6), 2012. On (b)(6), 2012, the patient's mother reported that this vns patient had undergone lead revision surgery on (b)(6), 2012. She also reported that, as of (b)(4) 2012, the patient had no voice at all. On (b)(6), 2012, it was reported that the patient was still hoarse as of the previous week. On (b)(6), 2012, it was reported that the patient's device was never programmed on; however, diagnostics were performed at the time of surgery with ok results. Attempts for product return have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2682941
« Last Edit: October 01, 2015, 06:45:48 AM by dennis100 » Logged
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« Reply #40 on: September 07, 2012, 07:50:56 AM »

Model Number 304-20
Event Date 07/31/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
On (b)(6) 2012, a nurse practitioner reported that the vns patient's leads were implanted on the right vagus nerve instead of the left. On (b)(6) 2012, the surgeon reported that he could not find any place on the left vagus nerve to place the lead, therefore it was placed on the right vagus nerve. They turned on the device shortly after surgery and programmed the patient to an output current of 2. 0 ma and the patient started experiencing more spasms. The patient's output current was then lowered to 0. 25 ma. Then when the settings were increased up a level, the patient started having spasms again. The surgeon stated that he was considering taking the patient back to surgery as he was wondering if the patient's spasms were due to the lead placement. The surgeon then later reported that he did not think he could get another lead on the left side so they went for right side replacement even though he knows the manufacturer's labeling is for left side placement only. With the device on the left side the patient was able to tolerate settings of up to 2. 5 ma. However, once placed on the right side the patient was only able to tolerate a setting of 0. 25 ma. A setting of 0. 5 ma, which is what the magnet mode was set to, resulted in the patient experiencing significant laryngospasms. The patient was not scoped to make sure it was contraction of the laryngeal cord causing the issue and not something else as the surgeon did not think it was necessary since swiping the magnet, set to 0. 5 ma, resulted in significant choking. The nurse stated that the patient immediately had adverse events with stimulation as the patient had been programmed to his original settings of 2. 0ma without giving the nerve a chance to acclimate to the stimulation. The patient is now being titrated up slowly and all his adverse events have stopped. The nurse later reported that after surgery on (b)(6) 2012, was the first time the laryngospasms/coughing were first observed. The nurse believes that it is due to the high stimulation from vns being turned on to 2. 0 ma after surgery. The events occurred with stimulation. Diagnostic results were within normal limits but the specifics were not provided. The patient does not have a medical history of laryngospasms prior to vns. The laryngospasms ceased after turning the settings down.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2713825
« Last Edit: October 01, 2015, 06:46:08 AM by dennis100 » Logged
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« Reply #41 on: October 03, 2013, 11:32:17 PM »

Model Number 105
Device Problem No Information
Event Date 07/18/2013
Event Type Malfunction
Event Description
Additional information was received that the surgeon did a procedure to treat the vocal cord paralysis and not the patient is experiencing an increase in seizures. At this time the surgeon does not know the cause of the increase in seizures. No other information was provided.

Event Description
The patient was to follow-up with orl surgeon. Upon further follow-up with regards to the seizures, the physician did not think the seizures have increased. The patient¿s seizures are noted to be occasional.

Event Description
Clinic notes dated (b)(6) 2015 reported in the history of present illness that since the vns has been placed, the patient has developed some vocal cord problems and was seeing an ent. No vns programming changes were made.

Manufacturer Narrative

Manufacturer Narrative
The supplemental report #3 inadvertently did not report this information from the physician.

Event Description
The physician indicated that the decreased motility of the vocal cord is probably related to vns therapy. The physician was unsure if the decreased motility of the vocal cord occurred with stimulation. The physician reported that the pneumonia has resolved and that the vocal cord paralysis is presumed to persist as her dysphonia has persisted.

Event Description
On (b)(6) 2013, it was reported that since the patient's vns revision surgery, the patient's voice has gone out. There were no further details on what this meant besides that the patient's voice got hoarse and the patient lost her voice temporarily. It was unknown whether this was with stimulation or not. The patient also had pneumonia after the surgery; however, the relationship to vns was unknown. Additional information was received that testing found the patient had some "sleepiness" of the left vocal cord. Per the physician, the pneumonia was likely related to the vocal cord not working as it probably allowed the patient to aspirate, causing the pneumonia. On the one month post-op visit, the physician noted that the wounds had healed nicely at that time. The patient was quite hoarse after surgery. Examination of the vocal cords indicated decreased mobility of the left vocal cord. It was noted that the vocal cord was not paralyzed, but had decreased mobility. The patient was experiencing mild aspiration. The physician gave the patient swallowing tips and recommended potential further action if the event did not improve; however, he was hopeful for resolution as there was some mobility. No additional information has been provided.

Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322853
« Last Edit: January 04, 2016, 08:25:21 AM by dennis100 » Logged
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« Reply #42 on: October 03, 2013, 11:33:57 PM »

Model Number 102
Event Date 01/01/2012
Event Type  Injury  
Patient Outcome  Other
Event Description
The patient has been diagnosed with left vocal cord paralysis, confirmed on direct laryngoscopy. Symptoms developed about six months after surgery. The physician presumes that it is due to compression, ischaemia, or fibrosis and requested literature on the subject as it was not related to direct surgical injury at the time of surgery. Clinic notes were received which indicate the patient's voice became noticeably weak about six months ago when the settings were changed due to shortness of breath. This weakness deteriorates presumably in relation to periods of stimulation. The patient does not have any significant stridor, respiratory distress, or difficulty swallowing at present and there is no history suggestive of significant aspiration. On the date of this visit (date unknown), the notes state that the patient's voice was fairly normal and general examination was otherwise unremarkable. The patient was particularly co-operative during flexible laryngoscopy. The left vocal cord was immobile and sitting in a paramedian position with a reasonable degree of glottic closure due to compensation from the right side. During periods of stimulation, the left vocal cord seemed to be bowed and flaccid resulting in a larger phonatory gap. During this time, there was inadequate compensation from the right vocal cord with closure being predominantly supraglottic. The patient appears to have left vocal cord paralysis with good compensation. The phonatory gap increases during periods of stimulation, associated with glottic closure. The physician states in the notes that he does not have the experience to predict whether or not left vocal fold function will deteriorate with longer term vns use, but if this was to occur, the adverse effect on phonation could be managed by vocal fold augmentation. However, the physician very much doubts that this will be necessary. Programming history was provided which indicates the patient coughs with stimulation. The patient also experienced respiratory difficulties when sleeping and is seeing an ear nose throat doctor for his altered voice. Follow up with the physician indicates the respiratory difficulties were noisy breathing during sleep. There was also a complaint of breathlessness during exercise around the same time. This seemed to be due to stimulation, as reducing the on time but maintaining the approximate duty cycle improved the symptoms. It is difficult to be certain of this relation to stimulation as there was no specific monitoring performed to confirm this; however, it was assumed to be the case. The symptoms resolved with reduction of the on time. The physician stated that the respiratory difficulties became apparent over time, potentially as the current was increased. The patient has severe neurological problems and these issues were relatively minor in the broad scheme of things, per the physician. The patient did not have a medical history of this prior to vns. In regards to the vocal cord paralysis, the physician stated that the relationship to vns is uncertain. The onset of the dysphonia was six months after implantation. There was no trauma at that time. Nerve injury possibly occurred at the time of surgery and the manifestations were delayed. The discomfort and prominent cough at very low stimulation following implantation might suggest an acute problem following implantation. There was no periodicity to the dysphonia and it was not related to vns stimulation. The ent exam indicated permanent left vocal cord paralysis. As intervention, the vns may be turned off as it does not seem to have been effective in reducing seizures over the last two years. No other causal or contributory programming or medication changes, besides the usual gradual increase in stimulation current each month following implantation, preceded the onset of the event. The patient does not have a medical history of vocal cord paralysis prior to vns. No additional information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3338126
« Last Edit: October 01, 2015, 06:46:57 AM by dennis100 » Logged
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« Reply #43 on: October 03, 2013, 11:34:26 PM »

Model Number 103
Event Date 08/16/2013
Event Type  Injury  
Patient Outcome  Hospitalization
Manufacturer Narrative

Event Description
On (b)(6) 2013, a patient¿s mother reported questions about voice alteration after surgery. She also indicated that the patient had to stay overnight for observation related to bleeding in the operating room. The physician wanted to watch the patient¿s incisions to ensure that no swelling occurred in the throat area. The patient was reported to be doing okay but had concerns about high pitched voice tone. Follow-up with the surgeon showed that there was no record of the patient experiencing voice alteration. The patient was last seen on (b)(6) 2013 and there were no complaints of voice alteration or hoarseness. Attempts for additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3355791
« Last Edit: October 01, 2015, 06:47:21 AM by dennis100 » Logged
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« Reply #44 on: December 06, 2013, 12:30:44 AM »

Model Number 101
Event Date 06/08/2010
Event Type  Injury  
Patient Outcome  Other
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2010 that indicated the patient feels her stimulator go on quite strongly at night a couple of times and has voice changes from the vns. It was stated that the vns was checked and it works fine. The patient¿s settings were noted to be output=1. 75ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 5min/eri=no. Clinic notes dated (b)(6) 2010 indicate that although her voice changed while the vns was turned on, it was not as significant as before. The patient stated that she only had one time when she had decreased hearing in her ear and ear pain. The physician adjusted her vns settings by increasing the output current from 1. 5ma to 1. 75ma and the magnet from 1. 75ma to 2ma. The rest of the settings were left at frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 5min. Good faith attempts for further information from the physician have been made but no additional information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3468339
« Last Edit: October 01, 2015, 06:47:35 AM by dennis100 » Logged
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« Reply #45 on: January 12, 2014, 10:33:12 AM »

Event Date 01/01/2010
Event Type Injury
Manufacturer Narrative
Article citation: elliot, robert, a. Morsi, a. Silverberg, c. Carlson, e. Geller, o. Devinsky, and w. Doyle. "vagus nerve stimulation in 436 consecutive pts with treatment-resistant epilepsy: long-term outcomes and predictors of response. ".

Event Description
It was reported in a scientific article that a vns pt experienced varying degrees of vagus nerve injury that included mild but permanent hoarseness. Good faith attempts to obtain add'l info from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2017214
« Last Edit: February 03, 2018, 03:18:39 AM by dennis100 » Logged
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« Reply #46 on: February 07, 2014, 12:20:35 PM »

Model Number 103
Event Date 12/27/2013
Event Type  Injury  
Patient Outcome  Other
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
« Last Edit: October 01, 2015, 06:48:37 AM by dennis100 » Logged
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« Reply #47 on: February 07, 2014, 12:21:37 PM »

Model Number 304-20
Event Date 11/05/2013
Event Type  Injury  
Patient Outcome  Other
Event Description
It was reported that the patient has been speaking at a whisper ever since implant and that the neurologist believes the patient has vocal cord paralysis. It was reported that the surgeon does not believe that the patient's vocal cords will stay this way. The physician believes that this is related to the vns implant surgeon and will be evaluating the patient further to see if the symptoms improve. The patient's settings were adjusted, but it was reported that the patient's voice was still at a whisper. Attempts to obtain additional information will be made, but not additional information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3578970
« Last Edit: October 01, 2015, 06:49:02 AM by dennis100 » Logged
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« Reply #48 on: May 09, 2014, 03:27:10 AM »

Model Number 105
Event Date 01/16/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported by the ent physician that the vns patient had laryngeal spasms with stimulation. Additional information was received from the neurologist stating that the patients' vns device settings were decreased to decrease symptoms. The patient did not have a prior history of laryngeal spasms prior to vns. The patient cannot tolerate even low levels of stimulation and his seizure frequency has not changed with vns; however, the patient is experiencing an improved recovery from his seizures with vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717906
« Last Edit: October 01, 2015, 06:49:38 AM by dennis100 » Logged
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« Reply #49 on: June 06, 2014, 12:42:49 PM »

Model Number 302-20
Event Date 02/11/2006
Event Type Injury
Patient Outcome Other
Event Description
The patient reported that following vns explant due to infection (mfr. Report #1644487-2014-00416) the patient was unable to talk for eight months. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3785469
« Last Edit: October 01, 2015, 06:50:00 AM by dennis100 » Logged
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« Reply #50 on: June 06, 2014, 04:19:44 PM »

Model Number 101
Event Date 03/01/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the vns patient was experiencing an increase in seizures and pain/tightening at her lead site for the month prior to her office visit on (b)(6) 2014. The patient¿s device was not at end of service and had normal lead impedance (dc dc 2). The neurologist stated that the generator battery was probably low and was causing the patient¿s issues. Until recently, the patient was seizure free since vns. The patient also recently began experiencing daily auras. The patient had a bump on her neck that appeared a month before the office visit. The neurologist stated that the lead may no longer be tied down. The patient did not experience any pain when the lead site was touched but intermittently when vns stimulation occurred. X-rays were taken but have not been provided to the manufacturer for further evaluation. The patient was referred for generator replacement surgery. No known surgical interventions have occurred to date. Clinic notes were received indicating that the patient¿s device had not been interrogated for the past ten years. The patient reported having a tingling feeling at the generator site and can still feel stimulation that sometimes caused her to have voice hoarseness. As the patient¿s auras were becoming more frequent, the patient¿s settings were increased. Review of the available programming and diagnostic history showed the last known device settings were from 04/11/2003.

Manufacturer Narrative
Review of the available programming and diagnostic history.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3804675
« Last Edit: October 01, 2015, 06:50:34 AM by dennis100 » Logged
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« Reply #51 on: June 06, 2014, 04:20:23 PM »

Model Number 103
Event Date 03/25/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient underwent surgery to explant her generator on (b)(6) 2014. It is unknown if the patient¿s lead was explanted during the procedure. Following vns implant surgery, the patient was experiencing dyspnea, severe personality changes, chest pain, voice hoarseness and cough. The explanting facility will not return the explanted device to the manufacturer for analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Event Description
Additional information received from the physician¿s office revealed that there was no indication anything was wrong with the vns device. The patient presented at the office on (b)(6) 2014 to have the device programmed on and stated that she did not like the feeling of a foreign metal object in her body. The patient had anxiety due to the presence of the device and did not have any personality changes. It did not appear that the patient had any anxiety about the device until after it was implanted. The device was programmed on as planned and the next day, the patient complained of chest pain, shortness of breath, voice alteration, and coughing. The voice alteration and coughing were due to stimulation but the chest pain and shortness of breath were anxiety related. The physician¿s office advised the patient not to have the device explanted but did not see her again until after the explant occurred. The physician¿s office did not feel that any of the events were serious in nature and removal of the device did not occur to preclude a serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808552
« Last Edit: April 25, 2016, 02:50:18 AM by dennis100 » Logged
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« Reply #52 on: June 06, 2014, 04:21:00 PM »

Model Number 304-20
Event Date 03/25/2014
Event Type Injury
Patient Outcome Other
Event Description
It was reported that the recently implanted vns patient was experiencing voice hoarseness and difficulty swallowing water and thin fluids following implant surgery. The patient's device had not been programmed on following surgery. It was suspected that the implanting surgeon had damaged the patient¿s nerve during surgery. It was noted that the patient¿s coughing was not indicative of complete vocal cord paralysis but the patient may have partial left vocal cord paralysis that would resolve over time. The patient was referred for additional testing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824241
« Last Edit: October 01, 2015, 06:51:40 AM by dennis100 » Logged
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« Reply #53 on: October 01, 2014, 02:01:38 AM »

Type of device: stimulator, autonomic nerve   
Device brand name: VNS Pulse   
Device manufacturer's name: Cyberonics, Inc.   
Date of this report:(mm/dd/yyyy)
05/09/2013   
Describe the event or problem:
 
Notes from the history and physical: "Left vagal nerve stimulator became hoarse and other effects, so never used. Would like removed." Notes from the operative report:.." An incision was made in the upper chest in the site of the previous incision and brought down to expose the pulse generator. This was carefully dissected out of the subcutaneous pocket. The leads were dissected out as well...A second incision was made in the left side of the neck at the site of the previous incision here as well. This was brought down to expose the leads and the 2 anchors. The anchors were carefully removed and the leads exposed. The leads were then gently pulled inferiorly until they came under a small amount of tension. They were then cut as high as possible and allowed to remain attached to the vagus nerve itself. The pulse generator and leads were then removed without difficulty...The patient tolerated the procedure well and there were no apparent complications."   

The device(s) may have caused or contributed to: Potential for patient harm   

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=105135
« Last Edit: October 01, 2015, 06:53:32 AM by dennis100 » Logged
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« Reply #54 on: October 10, 2014, 12:29:49 AM »

Event Date 08/27/2014
Event Type Injury
Event Description
It was reported that the vns patient had developed an infection at his neck incision site and was experiencing voice alteration and painful stimulation. The patient had been implanted with vns for over a year. No further information relevant to the event has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113796
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« Reply #55 on: October 10, 2014, 12:30:33 AM »

Model Number 103
Event Date 08/21/2014
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
It was reported that the vns patient was experiencing an increase in seizures, was unable to perceive stimulation, had pain at the electrode site, and had a ¿hard mass¿ in the generator pocket. Follow-up revealed that the patient¿s generator was tested and diagnostic results showed normal device function. No trauma was reported to have occurred. The patient¿s device reportedly had migrated south but was not causing any harm to the patient. The patient had her magnet taped over her device to improve her voice hoarseness and gagging; however, the pain in the patient¿s neck did not resolve. X-rays dated were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The patient¿s magnet was taped over the generator so an assessment cannot be made in regards to the filter feed-through wires and the lead connector pin. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4101231
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« Reply #56 on: October 10, 2014, 08:21:15 AM »

Event Date 08/11/2014
Event Type Injury
Event Description
It was reported that the patient is complaining of vocal cord issues following generator and lead replacement. The physician believes that the issues are due to excessive handling of the vagus nerve during removal and replacement of the lead. The physician's plan is to continue monitoring the patient and anticipates that it will resolve over time. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4084117
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« Reply #57 on: October 10, 2014, 08:21:59 AM »

Model Number 304-20
Event Date 06/26/2014
Event Type Injury
Event Description
It was reported that the recently re-implanted vns patient was suffering from voice hoarseness. The patient was referred to an ent specialist. The neurologist stated that the voice hoarseness was believed to be due to vocal cord paralysis or nerve damage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4092866
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« Reply #58 on: November 07, 2014, 12:36:31 AM »

Model Number 304-20
Event Date 08/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
The physician reported that the patient¿s lead is showing under the skin and that he has never been able to see the patient¿s lead in the past. The patient was also noted to have some voice quivering. The physician stated that it is unclear if there was any trauma that could have caused/contributed to the lead protrusion but that the patient was in a bicycle accident 2-3 months after initial implant. The patient was referred to a surgeon. No patient manipulation or trauma to the device area that could have caused or contributed to the protrusion per the physician and no physiological changes. The physician indicated that the voice quivering is with stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4201849
« Last Edit: October 01, 2015, 06:54:06 AM by dennis100 » Logged
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« Reply #59 on: November 07, 2014, 02:49:06 AM »

Model Number 303-20
Event Date 08/05/2014
Event Type Injury
Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity, the vns patient began experiencing left vocal cord paralysis and voice hoarseness. An orl specialist diagnosed the patient with vocal cord paralysis and dyspnea and believes the events were related to vns surgery. The patient was undergoing orl therapy and the issues worsened. Attempts for additional relevant information have been unsuccessful to date. The lead discontinuity event was reported in manufacturer report # 1644487-2014-01110.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4178326
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