VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on May 11, 2011, 06:35:38 AM



Title: Voice/Speech
Post by: dennis100 on May 11, 2011, 06:35:38 AM
Event Date 12/01/2002
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated the patient's voice is completely gone. Ear, nose, throat performed laryngoscopy which confirmed that patient's left vocal cords are non-functioning. Patient is reportedly status post tracheostomy that has been healed for a long time. Neurologist will not increase programmed parameters until vocal cord paralysis is resolved. The patient is not seizure-free, but their seizures are considerably less than pre-vns even with low device settings. No intervention has been taken to date. Physician plans to see patient for follow-up at the end of january 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=442007


Title: Re: Speech
Post by: dennis100 on May 11, 2011, 06:36:29 AM
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Event Description
The pt has vocal cord paralysis as a result of implant surgery for the ncp system. Reporter also indicated that the pt was unable to talk at all until having surgery to help restore their voice.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=440935


Title: Re: Speech
Post by: dennis100 on May 11, 2011, 01:07:57 PM
Event Date 10/01/2002
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Vns pt does not want to eat or swallow and has stopped speaking. The pt has a history of electrical status epilepticus for five years and also has landau kleffner syndrome (subclinical seizures that cause cognitive and receptive language regression). The pt reportedly had some speech unitl approximately 4 months ago, but has since stopped talking. A g-tube was placed approximately 8 months ago because of the pt's refusal to swallow and difficulty in administering medications. It was reported that the pt's progress in school has dramatically declined and that the pt just lays around and doesn't really do anything anymore. The pt still has uncontrolled seizures with medications and vns therapy, but the vns has reportedly decreased the pt's postictal and recovery time. Treating neurologist has reportedly decreased programmed parameters, but does not believe that the pt's symptoms are related to the vns. Treating neurologist indicated that the pt's condition was caused by their natural history of landau kleffner syndrome and was medication-related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=468263


Title: Re: Speech
Post by: dennis100 on May 11, 2011, 11:30:11 PM
Event Date 06/24/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns pt had been diagnosed with vocal cord paralysis. The pt reportedly had a rough post-operative course with nausea, vomiting and seizures most of the night following vns implant. It was reported that the pt was on oxygen and a breathing tube after implant surgery. It was later reported that the pt had been diagnosed with vocal cord paralysis and that the pt was able to whisper. Neurologist indicated that the pt's voice may or may not come back and that only time will tell. Neurologist indicated that the pt's voice was hoarse but still audible. Stimulation was initiated three weeks postop. Treating neurosurgeon indicated that the pt's condition was secondary to surgery and that the pt would be referred to an ent if there was no improvement in a few weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=480075


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 12:56:23 AM
Event Date 05/29/2003
Event Type Injury
Patient Outcome Disability; .
Event Description
Reporter indicated that vns pt has lost their voice and now speaks very softly since vns implant. It was reported that the pt has left vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=468610


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 12:56:56 AM
Event Date 06/01/2003
Event Type Injury
Patient Outcome Life Threatening; Disability Required Intervention
Event Description
Reporter indicated that vns pt's programmed parameter were reduced due to loss of verbalization ability. The pt subsequently experienced an increase in seizure activity following the parameter reduction. Treating neurologist plans to increase programmed parameters again after the pt completes one month of treatment with a speech therapist. Investigation to date has been unable to determine the severity of the seizure increase and the speech disorder.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=472107


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 03:35:53 AM
Event Date 09/29/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Vns patient was unable to speak above a whisper and unable to drink liquids that are not thickened since vns implant. The patient reportedly pulled out et tube postoperatively while in recovery. Further follow-up with treating neurologist revealed that the patient has probable vocal cord injury secondary to intubation. Stimulation has been initiated and the patient has been referred to neurosurgeon for follow-up. Investigation to date has been unable to determine whether the patient has been diagnosed with vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=498071


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 07:53:39 AM
Event Date 11/05/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns pt lost their voice after implant surgery. Stimulation has not yet been initiated. The pt has been referred to ent for evaluation. Treating neurologist and neurosurgeon plan speech therapy and do not plan to initiate stimulation until hoarseness resolves.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=506684


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 08:53:58 AM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt was diagnosed by an ent with vocal cord paralysis following vns implant. It was reported that the pt was implanted several months before and that their voice has been a hoarse whisper since implant. Stimulation has not yet been initiated as treating neurologist is reportedly waiting for vocal cord paralysis to resolve. Treating ent reportedly indicated that the vocal cord paralysis could be corrected with surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=513094


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 08:54:26 AM
Event Date 11/04/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns pt has been referred to an ent for evaluation because pt had not regained their voice two months-post-implant. Further follow-up revealed that the pt was diagnosed with vocal cord paralysis. The ent planned to wait 4 or 5 months to see if the vocal cord paralysis resolved on its own without intervention. The pt reportedly had this problem immediately after implant surgery and before the device was programmed to on. Stimulation has since been initiated and programmed parameters are being increased periodcally.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=510217


Title: Re: Speech
Post by: dennis100 on May 12, 2011, 12:51:39 PM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that the patient has experienced an increase in seizures since re-implant surgery. The patient is being seen by neurologist every two weeks due to increase in seizures. It was also reported that the patient's speech has slowly decreased and that now patient is non-verbal. Report also indicated that the magnet has been effective when using it to abort the patient's seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=516684


Title: Re: Speech
Post by: dennis100 on May 13, 2011, 01:16:39 AM
Event Date 05/13/2004
Event Type Injury
Patient Outcome Disability;
Event Description
Pt has not been able to talk above a whisper since vns implant. The pt reports no dysphagia, no odynophagia, no history of aspiration. Swallowing is reportedly not affected. It was reported the pt had an ent evaluation resulting in diagnosis of left vocal cord paralysis. Treating phyicians expect the hoarseness to continue for several weeks/months; however, there is an expectation that it will improve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=533225


Title: Re: Speech
Post by: dennis100 on May 13, 2011, 01:17:15 AM
Event Date 05/05/2004
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns patient has experienced hoarseness since implant surgery. The patient reports that their voice is getting better slowly, but that patient sill cannot talk loud at all. Treating neurosurgeon reportedly indicated that it may take another 1 to 2 months for the patient's voice to recover and that this problem was not attributable to the surgery. Investigation to date has been unable to rule out permanent damage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=532876


Title: Re: Speech
Post by: dennis100 on May 13, 2011, 01:17:57 AM
Event Date 01/01/1999
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Manufacturer Narrative
H. 6. Ncp system labeling lists voice alteration (hoarseness) as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt requested explant of device due to severe dysphonia and lack of efficacy. It was reported that the pt had never had efficacy with the vns therapy and that multiple different programmed settings were attempted to obtain efficacy. The pt does feel stimulation, indicating propor device function. Neurologist believes that the pt's symptoms are related to stimulation and has referred pt to neurosurgeon for consult regarding device removal. The pt's device has been programmed to off as the pt considers whether or not to have device explanted. The pt has not been diagnosed with vocal cord paralysis to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=531188


Title: Re: Speech
Post by: dennis100 on May 13, 2011, 04:01:58 AM
Event Date 06/14/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt underwent lead explant surgery due to infection and voice alteration. It was reported that the pt lost their voice folliowing vns implant surgery and that they had not regained it over one month later. Additionally, it was reported that the neck incision site was infected and inflamed. The generator was left in place with hopes of reimplanting a new lead in approx 6 months, but the pt's family member indicated that the pt would probably not choose to be reimplanted. 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=539405


Title: Re: Speech
Post by: dennis100 on May 13, 2011, 08:09:52 PM
Event Date 02/16/2005
Event Type Injury
Patient Outcome Required Intervention; .
Event Description
Vns pt has experienced a "high-pitched" voice since implant. The pt was reportedly referred to a speech pathologist. Further follow-up with treating neurologist revealed that the pt had not been diagnosed with vocal cord paralysis, but that pt had shown no improvement. Stimulation was initiated two weeks post-implant. Neurologist indicated that a steroid was tried to treat the pt and that pt see an ent for speech therapy. Investigation to date has been unable to determine whether the pt has vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=596961


Title: Re: Speech
Post by: dennis100 on May 17, 2011, 03:58:06 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a patient underwent vns surgery, and the patient then experienced nerve damage, trouble with their voice, and partial paralysis of the face. Attempts to gather additional information from a medical professional have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=932366


Title: Re: Voice
Post by: dennis100 on May 18, 2011, 02:20:30 AM
Event Date 11/01/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Initial rptr indicated, that they had just seen the pt in the office for the first time. It was reported "that they were having more voice alteration during on time and now pain with stimulation (no location provided). This had been at the same settings for a year. " add'l info was provided from the site "the pt is experiencing continuous voice change and pain around the carotid when the device stimulates, the pt was seen in the office and the settings were lowered and the pt would be brought back to have diagnostics performed. " it was later reported, the pt underwent complete revision surgery for a "lead break". Good faith attempts will be made for add'l info and prod return for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968151


Title: Re: Voice
Post by: dennis100 on May 18, 2011, 01:06:53 PM
Event Date 01/17/2008
Event Type Injury
Patient Outcome Disability; Other
Event Description
Reporter indicated that a vns patient was experiencing voice alteration. Additional information indicated that ent was involved and it was reported that the patient's ent is "questioning vocal cord paralysis. " the relationship to this event to vns is unknown at this time. Further, it was also reported that the patient did not sustain any injury or illness. Good faith attempts are being made to obtain additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=998836


Title: Re: Voice
Post by: dennis100 on May 18, 2011, 01:07:26 PM
Event Date 12/01/2007
Event Type Malfunction
Patient Outcome Other;.
Event Description
It was reported to mfr that the vns patient had revision surgery due to high lead impedance believed to be due to a possible lead discontinuity. Further follow up with the treating physician revealed that the pt had presented at an office visit complaining of pain, shortness of breath, and voice alteration which were all described as constant. A system diagnostic test was performed and revealed high lead impedance. As a result, the physician disabled the device and the adverse events resolved. The pt was referred for revision surgery. There was no trauma, manipulation, or other believed cause of events. X-rays were not taken prior to surgery to assess the continuity of the system. During surgery, a new system was implanted and only the generator was explanted, as the surgeon opted to leave the existing lead implanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=997057


Title: Re: Voice
Post by: dennis100 on May 25, 2011, 11:48:43 AM
Event Date 01/01/2006
Event Type Injury
Event Description
Physician reported that the pt always had voice alteration with stimulation since implanted and in the last few days that pt has not been able to speak at all. No additional information was attainted. Good faith attempts to obtain additional information has been unsuccessful.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1440163


Title: Re: Voice
Post by: dennis100 on May 31, 2011, 10:31:54 AM
Event Date 12/18/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the patient was implanted in (b) (6) 2009 and cannot speak anymore. Patient was also coughing with stimulation. The vns was turned off and patient is following up with an ent physician. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1625486


Title: Re: Voice
Post by: dennis100 on June 01, 2011, 11:44:43 AM
Event Date 03/12/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The pt reported to manufacturer that since being implanted with their vns they could not talk. The pt was seen by an ent physician and it was noticed that they had left vocal cord paralysis. It was believed to have been caused by the vns surgery. The pt's physician is to decide if the vns is going to be programmed on or left programmed off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656918


Title: Re: Voice
Post by: dennis100 on June 03, 2011, 03:36:23 AM
Event Date 07/06/2010
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported that right after surgery, the pt started having jerking and jumping at the left neck area. Her face would also pull to the left as these were painful. Our consultant met the pt and the surgeon in the office the day of surgery and checked the device. It was confirmed that the settings were indeed off. Several system diagnostics were performed which all resulted in normal ok results with impedance around 1700 ohms. You could see the muscle twitching. The pt's surgeon felt it was not related to surgery. The patient went home. Later that day, it was reported that the pt started to feel numb and quickly became numb all over her body including her arms and legs. She also lost her ability to speak which did resolved. The pt's husband was not sure if it may have been a seizure, but she was coherent and understood what he said. She just couldn't respond to him. He called the ambulance and the pt was admitted to hospital. It was felt at the time all the pt events were related to pt stress and not taking her prescribed postoperative pain medications. While in hospital it was reported that the pt's generator area became red, swollen, and painful. The pt had an infection at the generator site and was being treated with antibiotics. Their infection did not resolve. During explant surgery a large amount of pus was noted around the lead and generator. They had their lead and generator explanted related to their infection. Their infection was related to their implant surgery. Good faith attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774911


Title: Re: Voice
Post by: dennis100 on June 05, 2011, 12:12:44 AM
Event Date 03/05/2001
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that when pt attempts to communicate, no sound occurs. Possible vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=324750


Title: Re: Voice
Post by: dennis100 on June 05, 2011, 12:13:25 AM
Event Date 03/16/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter reportedly had lost voice 2 days post-implant and had not regained it.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=337304


Title: Re: Voice
Post by: dennis100 on June 05, 2011, 12:14:02 AM
Event Date 07/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that since implant, patient's voice is gone and they experienced an awful cough, chokes on fluids, and has shortness of breath. It was reported that patient was seen by the ear, nose and throat who diagnosed left vocal cord paralysis. Further investigation revealed that the device was not turned on at implant. The device was programmed to on in mid-august 2001 and remains at 0. 25ma output current. Patient reported that they did not want to program the device to off to give the vocal cord paralysis a chance to resolve because pt is already having some seizure reduction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=363399


Title: Re: Voice
Post by: dennis100 on June 05, 2011, 01:00:35 PM
Event Date 01/01/2002
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt is experiencing extreme voice changes and burning sensation. Investigation to date has been unable to determine whether voice changes are constant or during stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435511


Title: Re: Voice
Post by: dennis100 on June 05, 2011, 01:01:50 PM
Event Date 12/24/2001
Event Type Injury Patient Outcome Disability;
Event Description
The pt's family member indicated that pt "lost their voice". Family member also stated that pt "can barely talk above a whisper and their voice is really hoarse". After two trips to the family md (12/2001 and 1/2002) pt was prescribed cough syrup with codeine and an inhaler; there was no improvement. When the vagal nerve simulator (vns) was turned on (1/2002), the neurologist noticed a lump on the pt's neck and referred pt back to the surgeon. Pt was told there was not a relationship between the vns, the lump, and the voice alteration.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=378834


Title: Re: Voice
Post by: dennis100 on June 05, 2011, 01:02:53 PM
Event Date 12/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that the patient initially suffered hoarseness after the vns implant surgery, but it went away. It was reported that suddenly the patient lost their ability to speak clearly. Patient went from a totally literate person to sounding like they have had a stroke. Their words are described as very garbled. It was reported that the patient has been seen by surgeons, the neurologist, a dentist and a speech therapist. A ct scan ruled out any problem with the lead wire. It was reported that the physicians do not believe that the patient's speech abnormality is related to the vns. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=382144


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice/Larynx
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 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


Title: Re: Voice
Post by: dennis100 on November 07, 2014, 04:32:43 AM
Model Number 102
Event Date 09/16/2014
Event Type Injury
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Clinic notes were received for the vns patient¿s office visits with her neurologist. On (b)(6) 2014, the patient reported that she was unable to perceive stimulation from her device and was experiencing voice alterations. The patient¿s device showed normal device function at the time and the patient¿s device output current was increased from 1. 5ma to 1. 75ma. It was noted that the patient was averaging one seizure per month that would last up to a minute in duration. The patient¿s seizures were triggered by illness or menses. On (b)(6) 2014, the patient reported that she had been experiencing in increase in simple partial seizures. It was noted that the patient had not experienced any complex partial or secondary generalized seizures since vns. The patient was no longer experiencing voice alteration and was not under a significant amount of stress. The patient¿s device did not show a near end of service condition but the patient was referred for replacement surgery. No known surgical interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 9 years until neos = yes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4167323


Title: Re: Voice
Post by: dennis100 on December 04, 2014, 11:06:00 PM
Model Number 102R
Event Date 08/01/2014
Event Type Injury
Event Description
On (b)(6) 2014, it was reported that the patient is having an increase in seizures that started in (b)(6) 2014. The patient had been seizure free and then began to have 3-4 seizures per month. He denies any change in medication or trauma to his neck/chest area. The patient has had the device so long that he cannot feel the stimulation or notice voice changes but his voice change can be heard in conversations. The physician referred the patient for generator replacement based on battery life calculations. Although surgery is likely, it has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4268185


Title: Re: Voice
Post by: dennis100 on December 04, 2014, 11:59:45 PM
Event Type Injury
Event Description
An abstract titled ¿complications of vagus nerve stimulation for epilepsy in children: how can we do better?¿ was received which included patient adverse events and product problems. There were 14 cases involving infections, two cases involving infections that were managed with aggressive antibiotics treatment and did not require device explant, and four cases that involved vocal cord dysfunction, lead fracture, or battery malfunction. This manufacturer report involves the case of the reported vocal cord dysfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4258198


Title: Re: Voice
Post by: dennis100 on December 05, 2014, 04:50:47 AM
Model Number 103
Event Date 10/07/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported on that the vns patient was referred for surgery to explant her device. The reason for the referral is unknown. It was noted that the patient was having problems with vocal cords. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4230522


Title: Re: Voice
Post by: dennis100 on January 09, 2015, 04:34:36 AM
Model Number 102R
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the patient has had an increase in myoclonus recently and still has vocal cord issues as well. It was noted that the patient needs a generator replacement. Although surgery is likely, it has not occurred to date. Clinic notes dated (b)(6) 2013 indicate that the patient still has voice issues and wants the vns taken out due to the vns causing the voice issues. It was previously reported on (b)(6) 2013 that the patient was scheduled for surgery as it was found that his trachea had narrowed. Per the patient, testing revealed paralysis of the right vocal cord however the left vocal cord was okay. The patient stated he had a history of respiratory/tracheal problems since involvement in accident requiring tracheostomy. Patient also reported experiencing a secondary upper respiratory infection as a result of the tracheostomy, for which lengthy treatment was required. Additional information has been requested from the physician but no further information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4328963


Title: Re: Voice
Post by: dennis100 on January 09, 2015, 08:40:42 AM
Model Number 103
Event Date 10/20/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491


Title: Re: Voice
Post by: dennis100 on February 06, 2015, 04:46:29 AM
Model Number 304-20
Event Date 07/01/2014
Event Type Injury
Event Description
It was reported that the patient has possible vocal cord paralysis. The patient had been experiencing difficulty with fullness in his voice that was constant and started right after his vns revision surgery. The physician was unsure of the association to vns. The patient was referred to an ent physician for evaluation of the vocal cords.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4398255


Title: Re: Voice
Post by: dennis100 on April 17, 2015, 11:59:06 PM
Model Number 304-20
Event Date 01/29/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient was experiencing severe dysphonia two weeks following surgery. The patient¿s device had not been programmed on since implant. The patient was sent to an ent for evaluation. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4). Corrected data: the initial manufacturer report inadvertently did not provide the suspect device udi. This report is being submitted to correct this data.

Event Description
Additional information was received stating that the vns patient dysphonia had improved but had not completely resolved. The patient¿s device was programmed on two week following implant surgery and well-tolerated by the patient. The surgeon indicated that the event was temporary and that no interventions have been planned or taken.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4587846


Title: Re: Voice
Post by: dennis100 on April 17, 2015, 11:59:37 PM
Model Number 103
Event Date 10/22/2014
Event Type Injury
Event Description
It was reported that the patient is very dissatisfied with his vns. States that he is still hoarse and wants the vns removed. Patient reported that he is hoarse all of the time. From the date of surgery his hoarseness was at a level 10, now it's at a level 8. He has not had any interventions with an ent physician. The nurse practitioner stated that the problem is with the patient, not vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4587744


Title: Re: Voice
Post by: dennis100 on April 18, 2015, 12:00:10 AM
Model Number 105
Event Date 01/15/2015
Event Type Injury
Event Description
It was reported that a recently implanted patient is having a hard time tolerating stimulation at around 0. 25mv - 0. 5ma. The patient experiences tightness in the chest, throat pain, and voice alteration and tachycardia associated with vns stimulation. Additional clinic notes were received for the patient. Clinic notes indicate that the patient was able to stop 3 seizures by swiping the magnet. When vns settings were increased from 0. 5 ma to 0. 75 ma, on (b)(6) 2015 the patient experienced mild palpitations and hoarseness of the voice with the increase but was reported to be able to tolerate it at the current level. Due to patient's concerns regarding discomfort with stimulation routinely (voice hoarseness, palpitations (tachycardia), chest discomfort and throat pain), the physician made a decision to decrease settings back to previous settings on (b)(6) 2015. Additional system diagnostic results was received. It was also reported that the patient continues to experience dysphagia when vns output current is increased to 0. 5 ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4583522


Title: Re: Voice
Post by: dennis100 on April 18, 2015, 12:00:43 AM
Model Number 103
Event Date 02/12/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient wanted to explant his device since he was experiencing voice alteration and an increase in seizures. Follow-up with the physician¿s office indicated that the patient was seen on (b)(6) 2015 and the device settings were decreased at the time. It was the patient¿s decision to lower the device settings who wants to eventually disable the device. It is believed that the patient¿s increase in seizures had resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4583181


Title: Re: Voice
Post by: dennis100 on April 18, 2015, 12:01:13 AM
Model Number 102
Event Date 01/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 from the patient¿s husband that his wife has been having vocal cord issues for the past year. He mentioned that she had been on antibiotics about 4-5 times over the past year and was seeing a physician who voiced some concern about the vns being so close to her vocal cord. Attempts have been made for additional information but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565990


Title: Re: Voice
Post by: dennis100 on May 08, 2015, 03:47:11 AM
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient had experienced hypoxia, coma, voice alteration, and other unspecified adverse events. It was noted that the patient did not receive efficacy from the device and that the patient¿s caregiver wanted to have the device explanted. No known surgical interventions have occurred to date. No further information relevant to the events has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4724926


Title: Re: Voice
Post by: dennis100 on May 08, 2015, 03:47:59 AM
Model Number 303-20
Event Date 03/03/2015
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. (b)(4).

Event Description
It was reported that the vns patient had presented voice alteration and dyspnea which debuted one day after the implant. The stimulation had not been enabled yet when the side effects occurred. The patient underwent speech therapy. The patient was referred to an otolaryngologist. Further information was received indicating that the patient had presented also dysphagia and left vocal cord paralysis. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Attempts to obtain further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4705329


Title: Re: Voice
Post by: dennis100 on May 08, 2015, 03:48:39 AM
Model Number 103
Event Date 03/13/2015
Event Type Injury
Event Description
It was reported that the vns patient requested to have her device explanted due to voice alteration. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4660490


Title: Re: Voice
Post by: dennis100 on June 05, 2015, 01:41:57 AM
Model Number 103
Event Date 04/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient has experienced voice hoarseness. The patient was last seen (b)(6) 2015 and had become more hoarse over the last 2-3 weeks from the time of the report. It was reported that the patient was now unable to speak. The patient has always had tolerable hoarseness due to the stimulation, but sometime after the recent generator replacement in (b)(6) 2014 her voice has progressively gotten worse. When she was evaluated by an ent, it was indicated that the ent assessed that the right vocal cord does not work. The patient noted that she does have thyroid issues per diagnostic testing, but it was not clear at the time of the report if this is related. Good faith attempts for additional, relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4786605


Title: Re: Voice
Post by: dennis100 on June 05, 2015, 02:05:54 AM
Model Number 304-20
Event Date 04/10/2015
Event Type Injury
Event Description
An adverse event form for a study patient was received indicating that the patient experienced dysphonia. It was noted that the dysphonia was ongoing and was mild. It was noted to be related to the implant procedure, but not vns stimulation. Treatment was modified and vns stimulation was initiated at low settings. The patient was not recovered and the event was not resolved. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4803030


Title: Re: Voice
Post by: dennis100 on June 05, 2015, 02:06:56 AM
Model Number 304-20
Event Date 10/17/2014
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2015 note that the patient has had some hoarseness since the placement of the vns. It was noted that a strobe shows vocal cord paralysis. It was noted that indirect examination of the larynx showed left vocal cord paralysis in a paramedian position. It was reported that the ent surgeon is considering surgery for the vocal cord paralysis. It was reported that the ent surgeon believes that the implant surgery is the direct cause of the vocal cord paralysis. It was reported that the patient will undergo vocal cord medicalization surgery to improve the hoarse voice. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4765594


Title: Re: Voice
Post by: dennis100 on June 05, 2015, 02:07:53 AM
Model Number 302-20
Event Date 03/01/2015
Event Type Injury
Event Description
It was reported that the vns patient complained of hoarseness since (b)(6) 2015. The programmed settings since (b)(6) 2014 were output current 2. 50ma, frequency 30hz, pulse width 250usec, on time 7sec, off time 0. 3min, magnet current 2. 75ma, magnet on time 60sec and magnet pulse width 500usec. The battery status was eos=no. It was reported that diagnostics returned impedance results within normal limits. The patient was explored by an otolaryngologist who found left vocal cord paralysis. X-rays on (b)(6) 2015 were reviewed by the healthcare professional and they were found to be unremarkable. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4867393


Title: Re: Voice
Post by: dennis100 on July 12, 2015, 06:51:16 AM
Model Number 102
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient's generator had migrated from its original position to the patient's armpit whenever she moved in a certain way. The patient was seen by the physician and referred for surgery to correct the migration of the device. The physician noted that the generator does shift significantly under the skin in the left pectoral region. Manipulation of the pulse generator causes significant discomfort to patient in the chest and also some hoarseness of the voice. Additional information was received that no trauma or manipulation is suspected. Diagnostics were reported to be within normal limits with no high impedance. Patient underwent full revision surgery on (b)(6) 2015. Diagnostics were attempted but patient experienced left neck pain and coughing with stimulation. Upon opening generator pocket the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead as well (reported in manufacturer report # 1644487-2015-04810). Upon opening the neck incision, surgeon noted that there was not adequate strain relief from the implant surgery and this caused "pulling and twisting" of the nerve. Both the generator and lead were replaced and post replacement diagnostics were within normal limits. The explanted generator is expected to be returned but has not yet been received by the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808411


Title: Re: Voice
Post by: dennis100 on July 12, 2015, 06:51:56 AM
Model Number 304-20
Event Date 04/20/2015
Event Type Injury
Event Description
It was reported that the recently implanted vns patient began experience voice hoarseness following implant surgery. Follow-up with the patient¿s physician revealed that the voice hoarseness was suspected to be due to left vocal cord paralysis. The patient was referred to an ent and for speech therapy.

Manufacturer Narrative
Suspect device udi: 0105425025750139111409221718091621244319910-0009-5204.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4857187


Title: Re: Voice
Post by: dennis100 on July 12, 2015, 06:52:46 AM
Model Number 102
Event Date 05/20/2015
Event Type Injury
Event Description
It was reported that the patient experienced dizziness, tingling sensation in the fingers and increased perception of stimulation recently. Patient¿s dizziness and tingling sensation in the fingers were later reported to be possible partial seizures. Patient had gone to the er as she does not have a neurologist and the er nurse was informed about the magnet uses to disable the device. Additional information was received from the er nurse that the patient reported normally feeling stimulation from vns about twice a day. On (b)(6) 2015, the patient felt constant stimulation and experienced neck pain with stimulation. When magnet was taped to temporarily disable the vns, the pain was initially worse and then gone. However this repeated in a pattern where the pain was worse and then gone for a few minutes. Patient visited another hospital and the patient¿s generator was programmed off using the vns programmer. Since disablement of vns on (b)(6) 2015, patient did experience an increase in partial seizures due to loss of therapy. The patient was later seen by a nurse practitioner on (b)(6) 2015 and the vns was turned on to low settings of 0. 5/30/250/30/5/0. 75/60/500. Even at these settings, patient experienced coughing and voice hoarseness with stimulation and therefore medical professional decided to turn device off again and refer patient for vns replacement surgery. Diagnostics were performed and the impedance was within normal limits. The device was not at end of service. Chest x-rays were taken and no obvious issues were found. There was no trauma per patient prior to the events on (b)(6) 2015. Patient¿s previous vns settings prior to the reported events were unknown as the previous neurologist retired. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4840313


Title: Re: Voice
Post by: dennis100 on August 07, 2015, 03:04:37 AM
Model Number 303-20
Event Date 06/01/2015
Event Type Injury
Event Description
It was reported that the patient experienced intensified coughing with stimulation recently as well as more voice alterations than usual. Additionally, a "scope" of the patients left vocal cord was done and it was alleged to look "sluggish. " this could mean that the vocal cords were not operating at full strength/ capacity per the nurse. Vns diagnostics were within normal limits. Patient had coughing and wheezing in early (b)(6). The patient's pediatrician had diagnosed that the patient has an reactive airway disease but was confirmed to not have pneumonia via x-rays. Patient also has asthma. Wheezing has resolved over time but patient has coughing in the morning and voice alteration. The coughing is prominent with increased activity of patient. Patient does not have a history of coughing or voice alteration prior to this event even though vns was implanted for several years. Patient will be doing a swallow test later. There was no recent trauma that is suspected to have caused these issues. No changes were made to the vns currently. If the cause of patient's issues are not determined after all testing and if vns is still suspected, adjustment to vns will be done at that time per the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4956887


Title: Re: Voice
Post by: dennis100 on August 07, 2015, 03:05:30 AM
Model Number 304-20
Event Date 05/15/2015
Event Type Injury
Manufacturer Narrative

Event Description
Initially, it was reported that the patient had a constant cough and she was unable to eat. It was also reported that the patient had no voice from the surgery but has improved. The patient's generator had not yet been programmed on. It was later reported that the physician met with the patient and the patient's voice was better and the coughing was also improving. The patient's generator has not yet been programmed on. Later it was reported that the patient is having discomfort where the leads are presumably when she turned her neck towards the right. It was also stated that the turning motion, with the device off, prompts coughing. The patient was seen again and reported that the generator site was tender. The generator was protruding, but has not extruded through the skin. Due to the complaints of pain at the electrode site and the generator site, coughing to the point of vomiting, and voice alteration, exploratory surgery was performed. The surgeon ran diagnostics with the lead in multiple positions and all measurements were within the acceptable range. The surgeon redid the strain relief loop and tie downs. After the surgery, it was reported by the physician that the coughing had been resolved and the patient's voice is almost back to normal. The pain in the area of the generator was attributed to the scar related to the vicryl suture. The patient's generator has not yet been programmed on, but the patient is once again complaining of voice changes and tightness when turning the neck towards the opposite side previously reported. The patient was referred to an ent for evaluation. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4911583


Title: Re: Voice
Post by: dennis100 on September 04, 2015, 06:11:56 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 04/08/2011
Event Type Injury
Event Description
It was reported that the vns patient was initially doing well with her device for the first three years following initial implant surgery; however, the patient had since been experiencing an increase in seizures and was given additional medications. The device was believed to be functioning as intended as the patient was having voice alteration occurring with stimulation on-times. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961379


Title: Re: Voice
Post by: dennis100 on September 04, 2015, 06:12:39 AM
Model Number 300-20
Event Date 07/15/2015
Event Type Malfunction
Event Description
On (b)(6) 2015 it was reported that the patient has high impedance. Normal mode diagnostics were performed which showed a dcdc of 7 and output=limit. The patient also reported painful stimulation. His report of the location of pain varies, but it does appear to occur when the device turns on. He reported that it's in his neck, then his head, and then his chest. They didn't want to perform system diagnostics due to the patient's report of painful stimulation at settings lower than the system diagnostic test settings. It was also noted that the patient has voice alteration when the device cycled on. The vns device was left on at the patient's request. The patient was referred to a surgeon. Although surgery is likely, it has not occurred to date. The physician reported that no patient manipulation or trauma occurred. She noted that a ct scan had been performed on the patient but not x-rays.

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=4959601


Title: Re: Voice
Post by: dennis100 on October 01, 2015, 07:23:14 AM
Model Number 103
Event Date 02/05/2013
Event Type Injury
Manufacturer Narrative

Event Description
The patient reported that she wants the device removed due to losing her voice since implant. The patient also reported that she is recently having issues with a burning throat, coughing, and difficulty swallowing. The patient has been consulting with surgeon to have the device explanted. The physician's neurologist reported that the patient's vocal cord paralysis was not related to vns therapy, surgery or the presence of the device. It was reported that the device has been it was reported that the patient's report of losing her voice is not true because she spoke with both the surgeon and neurologist.

Event Description
Clinic notes were received, which indicate the patient had vocal cord paralysis due to a vagal nerve injury in (b)(6) 2012. Follow up with the physician found that the vocal cord paralysis was first observed on (b)(6) 2013. The physician could not provide an assessment on the relationship of the vocal cord paralysis to vns; however, he stated that the paralysis was present at all times, and not only when the stimulation was on. The patient was referred for injections, but the patient declined. No causal or contributory programming or medication changes preceded the onset of the vocal cord paralysis. The patient does not have a medical history of vocal cord paralysis prior to vns, to the physician's knowledge.

Event Description
It was reported that the patient¿s vns was explanted on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3403350


Title: Re: Voice
Post by: dennis100 on October 03, 2015, 07:10:55 AM
Model Number 102
Event Date 05/29/2013
Event Type Injury
Event Description
Additional information received revealed that patient was scheduled for generator revision surgery on (b)(6) 2013. The surgery occurred as planned with only the generator being replaced due to end of service. Attempts to obtain the explanted product for analysis will be made.

Event Description
The explanted generator was returned for analysis which has been completed. During the analysis of the generator it was found to be at end of service as the result of normal battery depletion. There was no abnormal performance or any other type of adverse condition found with the returned generator.

Event Description
On (b)(6) 2013 clinic notes from the patient¿s (b)(6) 2013 visit were received which reported that the patient developed acute onset of mid-sternal chest pain described as a squeezing, non-radiating 10/10 pain associated with palpitations, diaphoresis, vomiting, and shortness of breath. The physician stated that none of these events were related to vns. The pain was relieved after receiving nitroglycerin and oxygen by ems. Since her hospital visit, she has had a negative heart catheterization and negative workup. During her hospital visit, there was confusion with her home medications and her history of seizures and she was noted to be having increased seizure frequency. It was reported that her vns was later interrogated over a year ago and that the patient has had difficulty finding a neurologist/epileptologist in her hometown who interrogates vns; thus, she has not had close follow up. The physician stated that during this visit voice alteration was noted during stimulation and the patient noticed a sensation of mild sharp shooting pains in the neck. The physician stated that she attempted to interrogate the vns but was unsuccessful and believes it was due to eos. The patient was noted to have a past medical history of ventricular tachycardia and that since implantation of the vns, her tachycardia episodes have decreased in frequency. The physician indicated that the recent increase in seizures activity is likely due to the decreasing battery strength of her vns and because of missing several doses of her keppra. It was reported that the patient had been admitted to the hospital on (b)(6) 2013 because the patient was having chest pain and thought she was having a heart attack. The physician confirmed that neither of these events is related to vns and that the patient was not actually having a heart attack; she had just misinterpreted her chest pain as such. It was stated that the handheld was not plugged into the wall, the wand battery was fine, and all cables and connections on the programming system were secured and properly seated. The physician confirmed that the wand was placed directly over the skin and was pressed firmly against the generator as the patient was wearing a hospital gown. The patient¿s vns still could not be interrogated. The patient was also moved away from all medical equipment that could be causing emi. The physician stated that she believes the patient¿s battery is depleted.

Event Description
Additional information was received stating that diagnostic results subsequent to explant revealed lead impedance was within normal limits (dc dc = 2), confirming proper functioning of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3250143


Title: Re: Voice
Post by: dennis100 on October 05, 2015, 11:08:01 AM
Model Number 102
Event Date 11/07/2009
Event Type Malfunction
Event Description
Product analysis was performed on the returned generator. The pulse generator diagnostics were as expected for the programmed parameters. No obstructions were observed in the header lead cavity or connector blocks. A bench lead inserted past the connector blocks. In addition, the in-line cavity go gauge test passed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the product analysis 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 generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative
Additional information was received which changes the product the report is reported on.

Event Description
The patient reported on (b)(6) 2013 that he felt his vns device was ¿not working right¿ because he was feeling his stimulation since a couple of days prior which he had never experienced before. He started to feel his device turn on and can feel it pulsating in his neck where his scar is which had never happened previously. He reported that the treating neurologist did increase the vns settings a few weeks ago, but he did not notice any problems then. He reported that he believed everything was fine at his last visit. The patient denied any trauma or event that would have initiated the symptoms. Later, the vns company representative attended the patient¿s follow-up appointment on (b)(6) 2013 with a treating vns physician to assess the patient¿s symptoms and check the vns device. The patient reported about six months prior, the patient started feeling pain with stimulation by his clavicle and that about a month ago, the painful stimulation got more intense and he described it as a ¿spreading pain¿ which began in the clavicle area. The patient also started experiencing intense voice alteration with stimulation and was not able to talk when the device was stimulating. Upon performing diagnostics on the patient¿s device on (b)(6) 2013, high lead impedance was obtained with impedance value greater than 10,000 ohms. Therefore, the patient¿s device was disabled on this date, per manufacturer labeling recommendations. Clinic notes from (b)(6) 2013 reported that the patient¿s output current was increased on (b)(6) 2013 from 2. 25ma to 2. 5ma. The patient continued to complain of a ¿vibrating sensation in the left cervical region which would be consistent with the area of the lead. ¿ the physician notes that ¿it appears the patient¿s lead is faulty and therefore the device is being turned off. ¿ the patient was referred for replacement surgery. However, the surgery has not occurred to date. The cervical spine and pa/lateral views of the chest x-ray report dated (b)(6) 2013 reported no anomalies regarding the vns device. Attempts for a copy of the x-rays and additional information have been unsuccessful to date.

Event Description
On (b)(6) 2013 it was reported that the patient¿s surgery ended up just a battery replacement. The surgical team could visually inspect that the lead pin was not fully inserted and full of fluid. When the pin was dried off and reinserted, the system diagnostics showed results within normal limits. On (b)(6) 2013 further details were received when it was reported that the patient¿s revision surgery was underway when the surgeons noted the pin on the generator was not fully inserted. The pin was cleaned and reinserted and the surgeons noted the pin came loose very easily when unscrewing the set screw. After pin reinsertion, the device was within normal limits with no high impedance observed. The surgeons, by referral from the neurologist, went forth with a prophylactic generator replacement. Again, diagnostics showed all systems within normal limits. The surgeons elected to not move forward with a lead revision at this point. The explanted generator was returned for product analysis on july 29, 2013. Product analysis is underway and has not yet been completed.

Manufacturer Narrative
Date of event; corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

Manufacturer Narrative
Review of device history records. Review of lead device history records confirmed all quality tests were passed prior to distribution. 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=3199351


Title: Re: Voice
Post by: dennis100 on October 08, 2015, 12:37:06 AM
Model Number 102
Event Date 07/12/2007
Event Type Injury
Event Description
On (b)(6) 2013, the patient¿s mother reported that the vns has caused him to lose the ability of his vagal nerve and also caused his stomach to stop working properly. The patient had to have a feeding port put in. The mother stated that the infrared actually ¿revved up¿ his vns.

Event Description
On (b)(6) 2013, the patient's mother reported that the patient had the feeding port removed and "everything" was working functionally. The mother indicated that the patient's device was turned off, the patient's symptoms started to go away, and the patient has improved. Additional attempts were made to the physician for information; however, they were unsuccessful. No additional information has been provided.

Event Description
The patient's mother reported that the patient was doing well. No adverse events were reported. The patient was in the hospital on (b)(6) 2013, but no other information was provided.

Event Description
It was reported that the patient's vns was programmed off on (b)(6) 2012. The physician reported that the patient's pulsating neck and voice alteration first occurred in 2006 and that the difficulty swallowing and choking, aspiration, and loss of consciousness began in (b)(6) 2011. It was reported that the patient went into shock and his heart stopped which was a reaction to tp nutrition and not related to vns therapy. It was reported that the loss of consciousness was unrelated to vns therapy and that the loss of motility of the patient's esophagus was unlikely related to vns therapy. The physician reported that the patient's pulsating neck, voice alteration, difficulty swallowing and choking, and aspiration are possibly related to vns therapy. The patient's mother reports that the patient's gi motility has returned to normal. The patient has no history of these events prior to vns therapy.

Event Description
On (b)(6) 2013 the patient¿s mother reported that since (b)(6) 2013, the patient has had to have his feeding port replaced at the hospital 5 times as he rips them out immediately after having them put in. The patient no longer has a feeding port and is now eating only soft foods and will be having a swallow test.

Manufacturer Narrative

Event Description
On (b)(6) 2013 when it was reported that the infrared on the wii almost burned out her son¿s vagal nerve and he has lost the ability to use his esophagus and had to have a feeding port put in. The reporter indicated that her son¿s problems began when they got a wii video game system about six years ago. She said that the infrared (ir) on the wii system revved up the vns to the point that it affected his voice and said you could see his neck pulsating. She said this happened every time her son was in the direct path of ir remote or receiver. She says that she did her own test using a board and a pillow - and she used this to block the ir signal. With the board and pillow blocking the ir signal, the patient was fine, but as soon as it was removed, the patient started exhibiting these adverse effects again (voice alteration and pulsating neck). She said that things started to get worse for her son, and in 2011, her son lost the ability to use his esophagus. She said she observed problems with choking and swallowing. She said she became very concerned about this when the patient started choking and aspirating and became unconscious. She says that an ambulance was called, and the patient was taken to the hospital. She said the physician at the hospital did an endoscopy and another test and found out that the patient lost motility of his esophagus and had problems with his stomach emptying. It was also said that the patient had ileus (bowel obstruction). The patient had to get a feeding port put in and during the implantation of the port, whatever they were giving him caused him to go into shock, and his heart stopped. She said the patient "came back" before they had to use the paddles to revive him. The reporter indicated that all these problems and complications boiled down to the vns device, so she had requested that the device be turned off. She said that she asked the physicians at the hospital to turn it off, which she thought they did, but it turns out they didn¿t. Their normal neurologist interrogated the device and saw it was still programmed on; therefore, the neurologist programmed the device off about 6 months ago. The reporter stated that after the device was disabled, the patient has been doing fine, and is even getting some motility in his esophagus back. Good faith attempts for further information from the neurologist have been unsuccessful. It was previously reported in (b)(6) 2011 that the patient was having problems with regurgitation and choking. The problem begins 3-4 hours after the patient is done eating and started a couple of months ago.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3127809


Title: Re: Voice/Speech
Post by: dennis100 on October 09, 2015, 04:01:47 AM
Event Date 04/06/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that following lead replacement for high impedance (mfr. Report # 1644487-2015-05532), the patient was re-admitted to the hospital with a sore throat, changes in voice, and difficulty swallowing. It was reported that the patient required thickened liquids to be prescribed. Further follow-up revealed that the day following the lead replacement the patient experienced a gruff, but quiet voice and coughing when drinking. The physician believes that these were probable side effects from the lead replacement. The device pulse width was decreased to 250ma. The patient was also prescribed paracetamol and ibuprofen. The patient was seen on (b)(6) 2014 at which time the side effects were much improved. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5074927


Title: Re: Voice/Speech
Post by: dennis100 on October 15, 2015, 10:27:29 AM
Model Number 304-20
Device Problem Fluid leak
Event Date 08/26/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient reported that the surgeon informed her that the lead had fluid in it when it was explanted which he believed caused her pain.

Event Description
It was reported by the patient's physician that the patient had been experiencing some adverse events associated with stimulation. The events started on (b)(6) 2012 and were described as a shocking pain, at the collar bone, which did not occur with every stimulation cycle. Additionally, the patient reported that she could see the lead pulsating during the stimulation. The patient was swollen all the way along the leads from the generator to the electrodes. The device was checked on (b)(6) 2012 and the diagnostics results were all normal and within normal limits. There was no reported trauma. It was reported that when the pulse width was lowered from 500usec to 250usec, the swelling went way within 15 minutes. X-rays were performed and the device was left enabled as the patient could tolerate the events and was doing well with vns therapy. Ap and lateral views of the neck and chest for patient were reviewed. The generator is seen in the left chest area. The filter feedthru wires appear intact and the lead pin can be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be behind the generator. The electrodes were observed in the neck and appear to be in proper alignment. The lead is seen routed down toward the generator. No lead breaks or fractures were observed. Based on the x-ray images provided, it appears that the generator and lead were implanted per labeling guidelines and no fractures or discontinuities are present. The cause of the reported issues could not be identified. Clinic notes were later received for this patient which indicated that the patient was also experiencing increased hoarseness with stimulation and protrusion of the lead. The swelling was said to noticeable and cause redness of the area. Additionally, the patient indicated that she was experiencing muscle spasms with stimulation as well. Following the decrease in settings, the muscle spasms and electrical shocks continued to a lesser degree and the patient also started experiencing an increase in seizures thought to be related to the lowered settings. On (b)(6) 2012, the pulse width was increased again to 500usec, and these settings were tolerated without issue for an hour. On (b)(6) 2012 the patient reported that she continued to have daily "shocking sensations" and "fluttering sensations" in the neck and near her armpit. These were said to be not severe. Additionally the patient reported that she is not performing any particular movements or actions when these feelings are occurring as it can happen when she is not moving and at rest. On (b)(6) 2012 the patient again reported daily electrical shocks with the shocking occurring 4 times on (b)(6) 2012. Additionally she reports neck swelling but indicated that she would not disable the device as therapy has been working for the patient. The patient was seen again on (b)(6) 2012. She reported that her shocking is dally and she can have up to 2 of the "shocking symptoms that startle her and make her jump" otherwise does feel the fluttering (feels electrical flutter) and pain with stimulation along the lead wires just under left collar bone. If she has those shocks, her neck swells and then it becomes red, then it goes into a chest pain/pressure. Diagnostics performed on that date were still within normal limits. While the patient indicated that there had been no manipulation or trauma, her husband indicated that there was pain in her chest caused by their dogs jumping on her. The patient was referred for revision and underwent a lead replacement procedure on (b)(6) 2012. It was reported by the patient's neurologist that, during the procedure, the surgeon identified small pin holes in the lead and bodily fluid inside the insulation. Attempts for product return have been unsuccessful to date as the hospital indicated that they do not have anything to return.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all quality and functional testing prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(6) 2012 indicating that the revision surgery had resolved the pain issues. Additionally a review of the device manufacturing records indicated that the lead had passed all functional and electrical tests, as well as all quality inspections prior to distribution. A user facility report; number: (b)(4), was also received. This reported that the patient was experiencing "electric like shock above the stimulator and over the pectoral region". During revision, fluid was observed inside the lead insulation. The generator was tested during the procedure and was found to be functioning properly. No additional information has been made available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2824925


Title: Re: Voice/Speech
Post by: dennis100 on December 19, 2015, 04:59:27 AM
Model Number 304-20
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the patient indicated that he was to undergo neck surgery due to laryngeal nerve damage from vns. It was reported that the patient was experiencing laryngeal spasms post vns implant. The surgeon indicated that the patient experienced "unusual vocal spasms during device stimulation"; however, no specific details were provided. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was referred for surgical consult due to dysphonia. The patient experienced a significant deterioration in voice quality following vns implant on (b)(6) 2011. Upon examination using a flexible fiberoptic, it was noted that the patient had periodic hyper-adduction of the left vocal cord. The left arytenoid excessively rotated medially preventing the right vocal fold from closing appropriately which caused the deterioration in voice quality. During stimulation off times, the vocal fold would return to midline position but did not move normally. When the device was disabled using the magnet, the phenomenon would stop. The surgeon stated that the event was due to vns stimulation. Laryngeal adductor botox administration improved the patient¿s symptoms but did not eliminate them. The patient was taken to the or to cut the recurrent laryngeal nerve by performing an ansa to rln reinnervation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3887010


Title: Re: Voice/Speech
Post by: dennis100 on December 26, 2015, 01:12:34 AM
Model Number 102R
Event Type Injury
Manufacturer Narrative

Event Description
It was initially reported that the patient had left vocal cord paralysis. The physician contacted the manufacturer inquiring about long-term side effects, specifically vocal cord paralysis. He reports that the patient¿s vocal cord issue has gotten progressively worse. The patient is continually hoarse and he has seen an ent and was told he would either have to shut off the vns or learn to live with it. The patient has been seeing a speech pathologist to improve speech which was done to improve function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3487935


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:15:14 AM
Model Number 302-20
Event Date 06/11/2013
Event Type Malfunction
Event Description
It was reported that high impedance was detected on the patient¿s vns system upon performing diagnostics at an office visit. No trauma was reported. X-rays were taken and reviewed by the medical professional(s); no gross lead fractures were reportedly observed. The patient was referred for vns replacement surgery. The facesheet received for referral for surgery indicated that the patient had an ed visit on (b)(6) 2013 clinic notes dated (b)(6) 2013 reported that the patient has had episodes of status epilepticus and also has had frequent breakthrough seizures. Recently, she developed increased seizure frequency, increasingly intractable and was accompanied with increased stuttering. The patients seizures had been markedly improved. ¿vns did seem to be of some benefit. ¿ high lead impedance was observed on this date, ¿suggesting the possibility of lead malfunction. ¿ the patient¿s epilepsy had been very well controlled. The patient did not appear to be having significant side effects. Pa/ap and cervical spine x-rays were requested. No vns programming changes were made. Previously on (b)(6) 2013, an anti-seizure medication was tapered due to behavior difficulties. The physician recommended increasing this medication again on (b)(6) 2013. The last available diagnostics in the manufacturer¿s database show that the system was functioning properly as last checked on (b)(6) 2012. Ap chest, ap neck, and lateral chest images were provided to the manufacturer for review. No gross fractures, lead discontinuities, or sharp angles are noted in the visible lead portion. Lead does appear to be present behind the generator and therefore, cannot be assessed. Based on the limited quality of the images available, a cause for the high impedance cannot be determined. The presence of a microfracture or a discontinuity in the lead portion not visible cannot be ruled out. Although surgery is likely, it has not occurred to date. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Review of device history records. Review of the lead manufacturing history records confirmed all quality tests were passed prior to distribution. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.

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
The lead analysis was completed on (b)(4) 2013. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The generator analysis was completed on (b)(4) 2013. The pulse generator diagnostics were as expected for the programmed parameters. 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 pulse generator.

Event Description
Additional information was received which reported that the patient¿s device was turned off on (b)(6) 2013. No trauma or manipulation was reported to have contributed to the high impedance. In the physician¿s opinion, there is nothing noted between the relationship of the patient¿s increase in seizures relation to vns. The patient had generator and lead replacement surgery on (b)(6) 2013. The explanted generator and lead were received by the manufacturer for product analysis on (b)(4) 2013. However, product analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3202882


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:15:53 AM
Model Number 304-20
Event Date 06/01/2012
Event Type Injury
Event Description
On (b)(4) 2013, it was reported that this patient wanted her device removed. The patient reported that she developed a blot clot in the left neck. She was informed by her surgeon that the she bled quite a bit in surgery and had to be transfused intraoperatively. Three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking. She reported that she saw a pulmonologist who performed a bronchoscopy and informed her that her left vocal cord is almost completely paralyzed and that he could see the lead next to the vocal cord. The patient was last seen on (b)(6) 2013 at which time her settings were adjusted. (increased settings have not affected her chest pain and shortness of breath adversely: it was no worse and no better. ) attempts for information have been unsuccessful. Surgery is likely and will be captured in mfr report #1644487-2013-01510. The patient had earlier reported that two days after her system was implanted she went to the hospital because she could not breathe or swallow. The patient was turned on one month later. The patient indicated that the swallowing issue was only occurring a couple of times per week and not necessarily coinciding with stimulation on times. The breathing issue occurred all of the time and was worse with stimulation. The patient also experienced painful magnet stimulation at the electrode site (magnet output current: 1. 0 ma). The patient also had incidents of pain at the generator site for the past two to three months. The patient did not experience any trauma. At the hospital, her vitals were noted to be fine and everything was okay. The patient¿s physician was unable to provide information as to the cause of the events. The patient also reported that a ct performed after surgery showed a blood clot at the lead site. Follow-up at a patient appointment in september showed that the pulsewidth and frequency were too high. Once the settings were adjusted, the patient was fine. Follow-up with the surgeon¿s office showed that the patient was seen for implant and again in (b)(6) for post-op follow-up and one more time in (b)(6), at which time she reported the pain and swallowing; however, these were determined to be only the result of the patient¿s settings. At the follow-up appointments, the patient was healing well without any complications. Follow-up with the neurologist showed that the patient was doing well and was seen in (b)(6)with no complaints. The patient was doing well with seizure control. The relationship of the blood clot to vns was unknown. The patient was on clonazepam, lamictal, keppra, lamotrigine, haproen, and vimpat at the time of the event. No causal or contributory medication changes precede the onset of the thrombosis. To the physician¿s knowledge, the patient did not have a medical history of thrombosis, and there were no pre/co existing medical conditions which may have contributed to the event. No medical interventions were taken. The patient was last seen on (b)(6) 2012, and reported no new symptoms or issues.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was hospitalized for several days due to shortness of breath. The patient was admitted to the hospital on (b)(6) 2014. The patient reported experiencing pain at her generator site while hospitalized but states that the pain had since resolved. The patient was also having seizures frequently. While hospitalized, the patient¿s device was found to be disabled. The neurologist at the hospital stated that the patient was suffering from depression and was taking too many aeds. Further follow-up revealed that the patient was seen by her following neurologist. The patient reported that her device had been disabled for two months prior to the office visit and that she was experiencing pain. The neurologist did not believe the pain was related to vns as the pain was not occurring at the patient¿s implant sites. After her office visit, the patient went to the emergency room due to a seizure on the bus that caused facial lacerations.

Event Description
On (b)(6) 2013, this patient reported that she was experiencing pain just above the generator site (related to the previous chest pain) and that she had been to the er numerous times for this discomfort. The pains reportedly began one week prior. The patient also indicated that this was in addition to the breathing problems and chest pains that began with vns implant. When the patient was at the hospital, x-rays were taken with no noted issues, and there was no infection. The patient was given pain medication. The patient noted that the device was previously turned off. This morning the settings were turned down, and the issues did seem to improve. Attempts for additional information have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122977


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:16:22 AM
Model Number 101
Event Date 03/22/2012
Event Type Injury
Event Description
It was initially reported that the patient had an episode of slurred speech and had trouble keeping track of things that lasted a few minutes. The patient did not lose consciousness, but was having word-finding problems. There was concern of a transient ischemic attack (tia). The patient did not go to the emergency room. The patient had a ct scan which was normal except for the right anterior temporal lobectomy. She has had no further episodes like this since. The patient does at a significant about of medication but there was no history that she took an excess amount of lamictal that could cause slurred speech but was not explain the word finding problems. The patient does not have major risk factors for a tia but has significant weight gain and had mild or borderline hypertension or pre-hypertension in the past. The patient had a lipid panel done 3 years ago and showed a normal total cholesterol, normal ldl and normal to elevated hdl. The physician listened to the patient's carotids arteries and her carotids are clear and her heart is regular rate and rhythm, and i could detect no murmurs. Follow-up with the physician did not provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3005242


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:16:47 AM
Model Number 102
Event Date 12/11/2012
Event Type Injury
Manufacturer Narrative

Event Description
No further information has been received after good faith attempts have been made.

Event Description
A patient's father called and reported that their child was now having changes in his speech, hearing loss, ataxia, vertigo (with testing underway). Good faith attempts are underway for further details about the reported events and their relationship to their device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901715


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:17:09 AM
Model Number 102
Event Date 02/16/2010
Event Type Malfunction
Event Description
It was reported that a pt began experiencing an increase in seizures approx 1 month after being implanted. The pt's seizures had been previously controlled well with medication, however, the pt was having side effects from the medication and got vns hoping that it would decrease the amount of medication she would have to take. The pt is also having difficulties walking and talking. There have been no medication changes to date. Good faith attempts to obtain additional information are currently being made with the pt's physician, however, the pt is not scheduled for an appointment until next month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1731041


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:17:40 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that the 'pt's electrodes were coming off the vagus nerve. " physician notes received by manufacturer indicated that the pt started to "have problems with seizure management" and was experiencing "pain over the left side of face, about the left eye, problems swallowing, problems speaking, and pain with tingling and burning referred into the arms, hands, and now sometimes legs. " "it appears that the lead attached to the left vagal nerve is not well attached and may actually be totally displaced. " the pt was admitted to the hospital, her settings were planned on being changed, and revision surgery planned in an attempt to resolve the pt's issues. Follow-up with the physician indicated that he looked at the pt's x-rays and did not see anything. He also explained that the normal mode diagnostics obtained were ok. Additionally, it was reported that the pt was experiencing headaches and jaw pain. The physician thinks tha it may have something to do with the pt's anatomy that causes the lead to come off. He explained that the pt was extremely psychotic prior to the vns and is now a "completely different person. " revision surgery was performed in 2007. Diagnostics were performed prior to surgery and obtained all normal results with a dcdc code of 3 and eri=no. It was reported that the surgeon found that there was inadequate strain relief "due to improper positioning of the tie downs, the lead was in the shape of a figure 8, and there was a great deal of scar tissue which was never removed from previous surgery that contributed to the pt's events. " the surgeon removed the lead implanted in 2006 and almost all of the scar tissue that was present on the vagus nerve of the pt. There was part of the scar tissue that he did not remove to avoid damage to the vagus nerve. The replacement lead's electrodes were positioned right below the original site of the scar tissue. Diagnostics performed after the surgery obtained normal results.

Manufacturer Narrative
Device malfunction is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861962


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:18:59 AM
Model Number 102
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported that the patient is looking to explant the vns device. The patient states that she needs the device removed because for the last several years she has complained of fatigue, diarrhea, decreased libido, headaches, blood pressure fluctuations and slurred speech. Follow-up with the physician showed that these issues are thought to be related to vns therapy, resulting in vagus nerve dysfunction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4634916


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:19:33 AM
Model Number 105
Device Problem Programming issue
Event Date 12/23/2013
Event Type Malfunction
Event Description
The lead device was received for product analysis on 12/17/2014. Analysis is underway but has not been completed to date.

Event Description
It was reported that the patient was scheduled for lead revision. The surgeon confirmed that lead replacement was not performed on (b)(6) 2013 and that more strain relief was added. The patient underwent lead replacement surgery. The existing generator was left in place. Device diagnostics were within normal limits (1107 ohms). The explanted lead is expected to be returned for analysis, but has not been received to date. Analysis of the generator was completed on 11/12/2014. 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 pulse generator.

Event Description
It was reported that the physician is unable to increase the patient's device output current above 0. 25ma because the patient coughs. The physician believes the generator is faulty. Clinic notes dated (b)(6) 2014 noted that the lead wire most likely needs to be repositioned. The notes mention that the patient's generator was replaced and the lead wire repositioned in 2013 and that since this surgery, the patient has been unable to tolerate previous vns settings and even at low settings he has severe coughing. The patient¿s device was increased to 0. 5 ma, but he coughed non-stop and the previous parameters were reprogrammed. The notes indicate that the current vns problem is likely related to the location of the lead wire in his neck. The physician recommends repositioning or replacing the lead wire. Clinic notes dated (b)(6) 2014 note that the patient has had consistent challenges with attempts to increase his vns settings in the past. When an attempt was made, post vns surgery in december, to program the device to previous vns settings, the patient was unable to tolerate these settings. He developed an electrical type pain in the left side of his neck and throat, transient inability to speak, palpitations, and tremors, likely attributed to by anxiety. The device was temporarily programmed off and then the output current was programmed back on at 0. 25 ma. The patient has no issues tolerating these lower settings. At 0. 25 ma, the patient is unable to sense activation of the device. It was also mentioned that chest/neck x-rays were taken to rule out the possibility of a lead fracture. There was some mild coiling in the neck on the left site as expected and no clear abnormalities were identified. The patient underwent generator replacement surgery. Device diagnostics were within normal limits. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Manufacturer Narrative
Corrected data, initial mdr inadvertently stated incorrect age and date of event.

Event Description
Product analysis for the explanted lead was completed and approved. A portion of the electrode array was not returned for analysis, therefore an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4216491


Title: Re: Voice/Speech
Post by: dennis100 on December 31, 2015, 01:20:02 AM
Model Number 304-20
Event Date 09/09/2014
Event Type Injury
Manufacturer Narrative
Event description, corrected data: follow-up report #1 inadvertently did not include patient's difficulty speaking during clinic visit on (b)(6) 2014.

Event Description
Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient complained of having shocking sensations in her neck along with dysphagia and muscle spasms. The patient had temporarily disabled her device with her magnet and the physician programmed the device off during the office visit. During an office visit on (b)(6) 2014, the patient¿s device was programmed back on and the patient subsequently had a nose bleed and coughing with stimulation. The patient¿s device was tested and showed normal device function at the time. The patient¿s device was again disabled for comfort. No patient trauma or programming changes preceded the onset of the patient¿s issues. The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description
Follow-up report #1 inadvertently did not include that the patient also experienced difficulty speaking during clinic visit on (b)(6) 2014.

Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was subsequently disabled and the patient was referred for surgery. The patient¿s physician was suspecting a potential issue with the lead. No known surgical interventions have occurred to date.

Event Description
Information was received that the patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were reported to be discarded and could not be returned to manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4132917


Title: Re: Voice/Speech
Post by: dennis100 on January 01, 2016, 10:15:53 PM
Model Number 302-20
Event Date 03/11/2013
Event Type Injury
Event Description
A patient implanted with the vns was diagnosed with breast cancer unrelated to their vns device. They had their vns explanted for treatment of that. Since explant they have noted significant hoarseness, coughing and choking during conversation. The relationship to their explant verses intubation is not known at this time. The patient's surgeons office reported that they are going to monitor the patient over the next 4 months. The patient was diagnosed with left vocal cord paralysis and starting to form a right contact ulcer of their chord from coughing and reflux. Their reflux is not vns related but from their coughing. The patient has distinct dystonia at the end of day and can barely talk related to their vocal chord issue. The patient is going to be monitored by an ear nose and throat physician.

Event Description
The ent physician's office indicated that they would not release information without a signed records release from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3132056


Title: Re: Voice/Speech
Post by: dennis100 on January 02, 2016, 07:15:15 AM
Model Number 302-20
Event Date 07/25/2008
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, this vns patient reported that she had vocal cord paralysis and was diagnosed in 2008. She did not have this prior to vns. The patient earlier reported that she felt her generator battery was running out. She stated that she was very happy with her device except that it had migrated in the last year and caused her discomfort now that it was closer to her armpit. Follow-up with the patient¿s physician showed that there were no issues managing the patient¿s device. It was stated that the patient wanted to be checked for positioning of her device due to migration. In (b)(6) 2012, the patient¿s physician reported that the patient had been experiencing slurred speech since she was seen in the office two weeks prior. At the last office visit, vns settings were raised and one medication was increased. The physician did not know if the slurred speech was related to the medication change or other issuers. Current diagnostics were all ok. The settings were also readjusted. The physician also stated the patient had lost a lot of weight intentionally and the patient felt like her generator was moving, but had no discomfort. All attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125603


Title: Re: Voice/Speech
Post by: dennis100 on January 07, 2016, 05:12:43 AM
Model Number 102
Event Date 01/01/2012
Event Type Injury
Event Description
On (b)(6) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2013 indicated that the patient has had increased seizure activity in the past three months. The patient was noted to be having refractory complex partial seizures and now needs a battery replacement. The patient was referred for generator replacement and it was stated that the patient's battery is dead. Clinic notes dated (b)(6) 2013 mention that the patient is not currently complaining of any pinching or pain from vns that he had in the past. The patient had reported on clinic notes dated (b)(6) 2012 that "it hurts when he rolls over" and he wants his vns removed. The clinic notes dated (b)(6) 2012 stated that the paint has been having multiple seizures all day; the patient had 7 seizures between 3:45pm and 4:05pm. The nurse stated that there have been no missed doses and no new medications. The clinic notes dated (b)(6) 2012 state that the patient was seen for a follow-up because of an increased number of spells. The patient did have at least 6 of those seizures that morning, but the physician found that the patient was spending most of his nights awake watching tv or playing video games. The physician stated that the patient has worn his vns out. The clinic notes dated (b)(6) 2012 indicated that the patient has pain when lying on the left side at his vns stimulator site and again the patient expressed desire for its removal. On (b)(6) 2012 the patient underwent a 4 day video eeg as the patient recently started having different type of spells. The new spells were described as humming, drooling, aphasia, and trembling. They were noted to last about 10 seconds, but can happen multiple times a day. The spells were suspected to be behavioral especially that changing his seizure medications was not helpful. The patient underwent generator replacement surgery on (b)(6) 2013 and it was noted that there was no end of service warning upon interrogation in pre-op. The explanted generator was returned for product analysis on (b)(6) 2013. It was later reported that the reason for generator replacement was for prophylactic reasons. The physician later reported that the increased seizures were first observed around (b)(6) 2012. The physician stated that the pain the patient feels is a "pinching" sensation in the vns neck site that occurs with stimulation. No patient manipulation or trauma occurred that is believed to have caused/contributed to the pain. No further information was provided from the physician. Product analysis on the generator is still underway and has not yet been completed. A blc was performed with the programming history available which showed 9. 05 years remaining until eri=yes.

Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis 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. During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3001934


Title: Re: Voice/Speech
Post by: dennis100 on January 11, 2016, 03:52:05 AM
Model Number 102
Event Date 02/01/2013
Event Type Injury
Event Description
The implant card was received which reported that the patient had prophylactic generator replacement surgery on (b)(6) 2013. It was reported that the explanted device has been discarded since the device has not been sent back to the manufacturer to date.

Event Description
It was reported that the patient's device has been turned off for a few years with perceived lack of efficacy (however, review of the manufacturer's programming history shows the device was programmed on in (b)(6) 2011, the last known date of history programmed by the nurse practitioner). The family requested to have it turned back on as vns therapy may help the patient. Upon turning back on, magnet stimulation caused the patient pain and he became cyanotic. Therefore, the magnet output current was decreased, and the device is currently on with no issue. The physician wants to replace the device due to the length of implant. Follow-up with the nurse practitioner revealed that the cyanosis is believed to be related to the battery nearing end of service although the eri flag is no. The magnet stimulation was only 0. 25 ma above the normal output current, and magnet use caused a violent cough and cyanotic episode. This led the nurse to believe the battery may be dying. The patient does not have a medical history of cyanosis, and there were reportedly no causal or contributory programming or medication changes precede the onset of the events. The patient's mother reported the device had been off for about 3-5 years, but this is not substantiated by the history in the manufacturer's database. Stimulus is on every minute and a half. The nurse indicated that there is suspected potential erratic stimulation as the battery is clearly not completely off as the patient is receiving therapy via witnessed voice vibration and cough, which she noted is just the patient's reaction to stimulation. She is not sure if the patient's symptoms are related to the device being turned off for some time. Both normal and system diagnostics were all okay but the specific results and programming settings were not provided. The patient is referred for generator replacement due to clinical end of service. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

Manufacturer Narrative
The initial report inadvertently reported the age incorrectly due to the date of event being reported inadvertently incorrectly. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993702


Title: Re: Voice/Speech
Post by: dennis100 on January 14, 2016, 07:22:53 AM
Model Number 103
Event Date 08/29/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2012 it was reported that the vns patient has an increase in seizures when the patient's mother uses his vns magnet on him. It was also reported that the patient has voice vibrations during stimulation. The physician later reported that he was not aware of the increase in seizures with magnet stimulation. The voice vibrations has noted to been since the vns was implanted and occurs with stimulation. The patient's stimulation was reduced due to the voice vibrations. The patient's diagnostics were noted to show a lead impedance of "ok". The physician stated that the increase in seizures is likely unrelated to vns and he has not taken any interventions as he is not convinced that the episodes are related to vns. The increase in seizures was relatively unchanged compared to pre-vns baseline levels. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2871434


Title: Re: Voice/Speech
Post by: dennis100 on January 17, 2016, 05:54:42 AM
Model Number 303-30
Event Date 11/01/2012
Event Type Injury
Event Description
Additional information was received when the two 3. 0mm leads that the surgeon had tried to implant in the patient were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
Brand name; corrected data: inadvertently listed "lead model unknown" instead of "lead model 303" on initial report.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was scheduled for an ent evaluation. It was reported that the patient has left vocal cord weakness. Clinic notes dated (b)(6) 2013 were received which indicate that the patient has multiple medical problems including chf, dm, htn, copd, and cva ((b)(6) 2012) who presents to the neurosurgery clinic to be assessed for placement of a vagal nerve stimulator. The patient reported that over the past year, his seizures have progressed in frequency and severity with him now having multiple daily grand mal seizures; when his seizures first occurred, he notes he had one seizure per year. In (b)(6), the patient reports that the surgeon attempted to place a vns on two separate occasions but failed. The patient reports that his vagus nerve was too large which lead to the vns leads breaking each time. The patient has had dense hoarseness since the procedures. Due to the cross reactions between his aeds and cardiac medications, as well as the progressive nature of his seizures, the patient has been urged by his neurologist and cardiologist to have a vns placement attempted once more. Additional clinic notes were received from a visit with another surgeon who indicated that the patient has history of an mri showing evidence of a stroke involving a right artery. The patient is having progressively worsening frequency and severity of seizures refractory to current medications and has 2 failed vns placement attempts. It was stated that an assessment of the patient's vocal cords with an ent is needed as the nerve may be transected or permanently damaged. The patient was seen by an ent specialist on (b)(6) 2013 for evaluation of hoarseness and dysphagia. The patient's quality of voice was raspy and rough and the severity was moderate with a significant impact on voice quality or function. The hoarseness started 11/1/2012 after vns surgery. Associated manifestations are dysphagia, frequent heartburn, sore throat, and tobacco use. The patient feels like foods and liquids don't go down and get stuck, also chokes and coughs at times - all new since surgery. The dysphagia is in the lower throat and the patient feels like food sticks in the throat, has a "lump in throat sensation" and states that even swallowing air can give him a choking sensation. The event is moderately severe. Aggravating factors include swallowing liquids, swallowing saliva only, and swallowing solid food. Associated manifestations include frequent heartburn or indigestion, frequent or chronic hoarseness, frequent or chronic sore throat, neurological problems, and pressure sensation in throat. It was found that there was mobility reduced motion in left cord. The right vocal cord had normal mobility but the left vocal cord was limited. There was good approximation of vocal cord phonation but paresis of left vocal cord was suspected. The patient was referred for a barium swallow to evaluate swallowing issues. The operative notes from the (b)(6) 2012 surgery stated that the vagus nerve was exceptionally large comparative to average anatomy. The 2 mm lead was coiled around the nerve and after coiling it was noticed that the vagus nerve due to the extensive size was being strangulated by the lead placement. Due to the large diameter of the vagus nerve it was felt that the coil could not be kept in contact with the nerve without jeopardizing safety. At that point the procedure was aborted with the incision was copiously irrigated with antibiotic solution. The patient was noted to be morbidly obese. On (b)(6) 2013 it reported that the patient has been going to speech therapy and his voice is improving. The patient started speech therapy about 2 weeks prior and is seen 2 times per week for 2 hours. The patient underwent a modified barium swallow on (b)(6) 2013 and the notes from this visit indicate that the diagnosis was dysphagia and that the patient had left vocal cord weakness. The patient was noted to have a history of coronary heart disease, cva, diabetes, chronic back pain, obesity, and hypertension. The patient had resilient (l) side weakness from cva, gerd. The patient had decreased voice and reports coughing on liquids. Gerd was not observed during evaluation. The patient had aspiration throughout assessment. Oral and pharyneal phases of swallowing are normal. No aspiration with modified barium swallow under fluoroscopy.

Event Description
On (b)(6) 2012 it was reported that the patient was to have an initial implant that day, but the hospital only had 2 mm leads in stock and upon opening up the patient, it was found that he has a big vagus nerve. The surgeon attempted to implant the 2 mm lead but it was constricting the patient's nerve so it was removed and the patient was closed up. The patient was asked to stayed overnight at the hospital to have surgery the next day with a 3 mm lead that was being shipped to the hospital. The patient's wife did not want the patient to stay overnight and wasn't sure she wanted to risk him going through another surgery if the new lead does not fit. On (b)(6) 2012, it was reported that the patient underwent surgery again with a 3 mm lead. The surgeon noted that the vagus nerve was swollen from the previous surgery and due to the patient having a very large neck he was not able to get good enough exposure of the nerve to get the electrodes around the nerve. The patient was closed up again and sent home. The surgeon also noted that the two 3 mm leads he tried to use lost their coil form after trying to coil nerve.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the returned leads. The condition of the returned leads was consistent with conditions that typically exist following manipulation of the leads. The patient stated that his voice is still raspy; he has to yell to be heard. The patient also mentioned that if he has a coughing fit, or laughs in a certain position, he feels like he is being chocked. The surgeon stated that he thinks the patient is too large and the leads will not fit. Although implant surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that a second surgeon told the patient he needed to see an ent (ear, nose, and throat) physician because the nerve might have been severed in the previous surgical attempt. The patient later reported that the second surgeon wants a veeg, ent evaluation, and or notes from the initial surgeon. The patient stated that he is still raspy, struggles to push out air and to be heard, when he touches the skin on the left side of neck to throat area, it feels numb. He also stated that if he laughs real hard or gets excited, he starts choking and may gag while drinking fluid, even on air. The patient stated that he has a history of choking on meat, but he thinks that is because he has no teeth.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744


Title: Re: Voice/Speech
Post by: dennis100 on January 18, 2016, 08:24:09 AM
Model Number 100
Event Date 09/01/2000
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received reported that a vns patient in (b)(6) 2000, developed aspiration pneumonia in association with a prolonged seizure and required a prolonged hospitalization. After this episode, she had an increase in nighttime seizure activity as well as significant weight loss. Despite a change in seizure medications, she continued to have intractable seizures without improvement. Consequently, she was transferred to another hospital for children in (b)(6) 2000. At that time, she was noted to be in status epilepticus. She was electively intubated and loaded with phenobarbital. She required multiple boluses of phenobarbital and dilantin to eventually control her seizures. Her vagal nerve stimulator was temporarily turned off at that time and reactivated later to help with seizure control. She was eventually extubated on (b)(6) 2000. She eventually required a nissen fundoplication and placement of a g-tube, as well as placement of a tracheostomy. This was required because of a significant regression in her speech, swallowing skills, mobility and cognition all of which occurred after her episode of status epilepticus on (b)(6) 2000. Prior to that time, she was able to walk and talk fairly normally. The patient has several different seizure types which occur frequently throughout the day. Thus far no further information has been received in regards to the patient's pneumonia and seizure events.

Event Description
No further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2838233


Title: Re: Voice/Speech
Post by: dennis100 on January 20, 2016, 11:04:42 AM
Model Number 103
Event Date 07/31/2012
Event Type Injury
Event Description
Additional information was received from the otolaryngologist confirming that the patient was diagnosed with left vocal cord paralysis post-operatively. The patient was only seen once by this physician on (b)(6) 2012. Per the patient, the onset of the vocal cord paralysis symptoms were first observed on (b)(6) 2012 (date of explant). The physician believes the difficulty swallowing and left vocal cord paralysis are a direct result of the explant surgery on (b)(6) 2012, with "likely nerve damage at the time of explant. " the physician was uncertain if the patient had a medical history of difficulty swallowing pre-vns since he only saw the patient after explant, but the patient reported the onset of the events was following explant surgery. No interventions were reported by the physician.

Event Description
A physician reported that the patient was complaining of difficulties swallowing, but this physician had not yet seen the patient but heard this information from a physician who was actually treating the patient. Then on (b)(6) 2012, additional information was received from the patient's treating physician's assistant reporting that the patient had experienced vocal cord paralysis. She inquired on the potential causal factors. It was indicated that the surgeon appears to be removing the lead coils from the vagus nerve which may be causing damage to the surgeon's patients. The patient reportedly sounds like a girl and does not appear to be improving at this time. The patient was referred to an otolaryngologist. Attempts for additional information from that physician have been unsuccessful to date. The patient's device was previously turned off on (b)(6) 2012 and explanted on (b)(6) 2012, due to shocking sensations, as captured in manufacturer report number: 1644487-2012-02733. Post-operatively, the patient was found to have left vocal cord paralysis by the otolaryngologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2815283


Title: Re: Voice/Speech
Post by: dennis100 on January 27, 2016, 10:14:36 AM
Model Number 304-20
Event Date 06/22/2012
Event Type Injury
Event Description
Reporter indicated a patient developed dysphagia, hoarseness, and difficulty speaking following vns implant surgery on (b)(6) 2012. The patient was seen by an ent physician and was diagnosed with "paresis of the plica vocalis, left recurrent laryngeal nerve paresis, and gastroesophageal disease". The events are felt to be permanent and due to the vns implant surgery. The patient had no pre-vns history of the events. The vns was turned down to low settings, as the patient requested it not be disabled. The patient also received prednisone medication. The patient describes the events as "bearable". Intraoperative vns diagnostics were reported as "ok".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739617


Title: Re: Voice/Speech
Post by: dennis100 on January 31, 2016, 02:46:28 AM
Model Number 304-20
Event Date 05/19/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, the vns patient reported that she has been experiencing some post-operation surgery effects. The patient was implanted on (b)(6) 2012. The patient stated that the vns is protruding, the patient's voice is altered and is high, and the patient's head is turned away from incision mark 4 and there is redness around the site. The patient's mother stated that the patient had to go back to the hospital overnight on (b)(6) 2012 due to pain as the patient had a hematoma and could not turn his head to the left. The patient's voice was still impaired. The patient's mother stated that the patient is doing better now. The physician later stated that they have no explanation for why the patient couldn't turn his head to the left however; the physician did not believe it was due to vns. The pain is located on the right side. No interventions were planned or taken and on (b)(6) 2012 the device was turned on. The physician does not believe the pain is related to vns. The physician clarified that there is no protrusion; the patient's mother was worried because the events occurred right after surgery, but the physician stated that the patient is healing quite nicely. The patient's implanted product information has been requested from the implanting hospital but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2620968


Title: Re: Voice/Speech
Post by: dennis100 on February 02, 2016, 06:39:47 AM
Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Describe event or problem: corrected data. Omitted x-ray review on initial mdr report. Manufacturer reviewed x-rays of implanted device. X-ray review by the manufacture revealed a sharp angle near the connector pin.

Event Description
Additional information was received that the patient's explanted generator will not be returned for analysis as it went home and was not returned. Their electrode was left in place because the patient had established fibrosis and it would have been too risky for the patient to properly dissect around the vagus nerve. X-rays were reviewed. The generator is placed in a normal arrangement on the upper left chest. In the ap chest x-ray view taken after implant, the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin appeared to be intact. A strain relief bend and loop were present, but not as specified by the labeling. Tie-downs were used to hold the bend and the loop. Portions of the lead appeared to be behind the generator and could not be fully assessed. Neither lead breaks nor acute angles were observed in the assessed portions of the lead. In the ap chest x-ray view taken after the report of "lead pulling sensation", the generator appears in the same placement, but seems to have been turned in an anti-clockwise direction with respect to the first x-rays. The filter feed-through wires still appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin were not intact and presented two sharp angles. The strain relief bend and loop were not present any more, and instead a sharp angle appeared right below the positive electrode, in the lead bifurcation.

Event Description
Additional information from the treating physician indicated the explanted material was provided to another medical professional for vigilance. At the moment attempts have been unsuccessful to date to obtain the explanted devices returned to the manufacturer for analysis.

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not list type of report. Initial report should have had indicated 30-day report.

Event Description
It was initially reported by a company representative that a vns patient experienced an increase in seizures and the suspicion the patient's lead being detached from the nerve. The patient's device was reported to have been programmed off. Additional information was received from the treating physician indicating the increase in seizures began in (b)(6) 2012 and around (b)(6) 2012, there was a complaint of lead pulling sensation. No patient manipulation or trauma was suspected to have contributed to the event and the system diagnostics from implant were within normal limits. Nonetheless, the physician believed the increase in seizures (below pre-vns level) was related to hardware failure. Moreover, the treating physician indicated the patient had undergone generator and lead removal surgery as the patient presented aspiration and bi-tonal voice. The physician indicated the explanted electrode was twisted on itself and believed this caused the winding tension on the nerve. Some manipulation of the electrode was seen in the generator area as the lead was coiled. At the moment replacement surgery will be planned after the patient ameliorates on the reported aspiration and bi-tone voice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2576889


Title: Re: Voice/Speech
Post by: dennis100 on February 15, 2016, 03:54:39 AM
Model Number 103
Event Date 09/02/2011
Event Type Injury
Manufacturer Narrative

Event Description
A vns following physician reported that he had a vns patient with intermittent dysarthria, more persistent over last few weeks with limited palatal movements, not clearly associated with vns being activated in a temporal/cyclical fashion. The patient was lost to follow up and presented back in clinic in (b)(6) 2012 with worsened dysphagia along with dysarthria for unclear reasons. A recent brain mri has not shown a new reason. The vns cannot be ruled out at this time. The patient's seizures are back to baseline. The patient was on keppra but their events worsened before the start of the medication and continued after stopping it. The patient is being treated with vitalstim swallow therapy that is on going. The patient also attends speech therapy. The patient events are still persisting and bothersome. Good faith attempts thus far have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465299


Title: Re: Voice/Speech
Post by: dennis100 on February 19, 2016, 04:40:43 AM
Model Number 102
Event Date 12/08/2011
Event Type Injury
Event Description
Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had a full revision surgery that day due to patient reporting it was causing her discomfort. The diagnostics test after surgery showed results within normal limits of 3400ohms. The explanted product was discarded by the hospital and therefore could not be returned for product analysis.

Event Description
Additional information was received on february 13, 2012 when the nurse practitioner reported that the patient's side effects were first observed on (b)(6) 2011. The nurse clarified that the side effects the patient was experiencing were coughing, vibration in voice, throat pain in left side under ear, and pain when coughing. No causal or contributory programming or medication changes preceded the onset of the events. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. The nurse stated that the events are probably caused by vns as the events occurred every minute or so and decreased when the vns was disabled on (b)(6) 2011. Interventions were programming the patient to an output of 0ma and referring the patient to surgery for vns replacement.

Manufacturer Narrative

Manufacturer Narrative
Additional information was received from the nurse regarding event date.

Manufacturer Narrative
Inadvertently did not include the product information on the follow-up report #2.

Event Description
On (b)(6) 2011, a vns treating nurse practitioner reported that the vns patient was complaining of side effects that they believed were related to the vns; what the side effects were was not specified. System diagnostics were performed which showed the device to be functioning properly. However, the patient's device was disabled and the patient was sent for x-rays and referred for surgery. Although surgery is likely, it has not yet occurred. (b)(4) attempts to the nurse for further information were made, but no additional information was received. The patient's implanted product information was requested from the hospital the patient was implanted in but they reported that the patient must sign a release form prior to providing that information. Since patient consent is not available at this time, the product information cannot be obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2406235


Title: Re: Voice/Speech
Post by: dennis100 on February 20, 2016, 12:49:03 AM
Model Number 102
Event Date 11/21/2006
Event Type Malfunction
Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.

Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.

Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.

Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008


Title: Re: Voice/Speech
Post by: dennis100 on February 21, 2016, 02:04:29 AM
Model Number 102
Event Date 01/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported via clinic notes dated (b)(6) 2011 that the patient has a history of stroke and has voice alteration with stimulation that is intolerable therefore she wants the device removed. The device was explanted and replaced on (b)(6) 2011. 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=2389375


Title: Re: Voice/Speech
Post by: dennis100 on February 25, 2016, 06:50:53 AM
Model Number 103
Event Date 11/02/2011
Event Type Injury
Event Description
It was reported by vns patient's parent that the patient experienced increased seizures, arrhythmia, voice alteration, coughing, vomiting, lack of efficacy, and pupillary miosis. The patient's parent also reported that the use of the magnet did not help abort the patient's seizures. The patient's voice was reported to be suppressed and sometimes presented vomit after coughing. The patient's mother indicated that a physician in (b)(6) tried to increase the frequency but it led to overstimulation for the boy, and the doctor switched the frequency back to 0,75 ma. The patient was reported to have been implanted in the us and now resides in (b)(6) where the patient is not being treated.

Manufacturer Narrative

Event Description
Additional information was received from the area representative indicating the physician confirmed the reported increasing seizures were due to lack of ramping the patient up. The dosing is being determined now and the patient is being followed up. Moreover, the physician confirmed the arrhythmia event had not occurred.

Event Description
Further information was received from the area representative indicating that a new physician saw the patient. The physician indicated he calibrated the generator and now is able to see improvement in the patient's clinical status. The physician indicated the patient's increase in seizures was due to normal disease progression. No arrhythmia was found on the patient in accordance to the physician. The reported lack of efficacy was due to sub-optimal programming of the vns hence not achieving optimal therapy. No interventions have been planned at the moment as the patient is doing well clinically. No further information was received regarding the other events as it was unknown if they were related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353606


Title: Re: Voice/Speech
Post by: dennis100 on February 25, 2016, 06:51:45 AM
Model Number 102
Event Date 09/01/2011
Event Type Injury
Event Description
It was reported via clinic notes dated (b)(6) 2011 that a vns patient has seizures almost daily with the frequency increasing over the last 2-3 months. Additionally, the patient's settings had to be adjusted due to voice alteration. The patient's dose of vimpat was increased in response to the seizures. The md states that he believes the seizures may be due to end of service as the patient's device has been implanted for approximately 7 years therefore the patient would be referred for generator revision surgery. Settings were 2. 25/30/250/30/1. 8/2. 5/500/60 and the changes made due to the voice alteration involved decreasing the signal frequency to 25 hz. It is noted that diagnostics performed resulted in a dcdc of 2 with an eri = no. Additional information received revealed that the physician could not related the seizures to baseline levels as he has only seen the patient a few times. There were no reports of trauma or manipulation and the physician believed that vns has worked well for the patient in the past. Based on the length of implant, the physician felt it was best to have the device replaced. The physician could not provide a cause for the increase in seizures.

Event Description
Product analysis of the explanted generator has been completed. 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 returned generator.

Event Description
Additional information received revealed that the patient underwent generator revision surgery in which the generator was explanted and replaced. The explanted generator has been returned to the manufacturer however product analysis has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2349331


Title: Re: Voice/Speech
Post by: dennis100 on February 25, 2016, 06:52:32 AM
Model Number 101
Event Date 09/19/2001
Event Type Injury
Event Description
On (b)(6), 2011 a vns patient reported that she had her vns explanted in 2001 because she was having voice alteration with every vns stimulation and that it would not go away. She reported that the surgeon left a portion of the lead in place when he explanted her device and now she needs to have an mri so wants the rest of the lead explanted. The patient's physician and surgeon in 2001 at the time of explant are no longer treating/implanting vns and therefore cannot be followed up with. Although the patient is seeing a new physician, he is not a vns treating physician and would not have answers to vns related questions from back in 2001 when the event occurred. The patient's programming history was reviewed and the patient was disabled on (b)(6), 2001. The last system diagnostics test listed was from (b)(6), 2001 which showed output=ok/lead impedance=ok/dcdc=1/eri=no.

Event Description
Additional information was received on (b)(4) 2011 when it was discovered that the explanted product had been discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2348811


Title: Re: Voice/Speech
Post by: dennis100 on February 27, 2016, 07:06:14 AM
Model Number 302-20
Event Date 05/31/2011
Event Type Injury
Event Description
It was reported by a company representative that a vns patient suffered from post-surgical aphonia, mild difficulty swallowing, and left vocal cord palsy as side effects from implant of vns therapy. The patient's vns was programmed on 17 days after surgery and visits to a speech therapist made a full recovery from the side effects. At the moment good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Initial report inadvertently listed incorrect brand name.

Event Description
Further information was received from the patient's treating physician indicating that the events of aphonia, mild difficulty swallowing and left vocal cord palsy were found right after surgery. The physician indicated the events were related to the surgical procedure. The patient complained of dry cough and throat, but the dysphonia was after the intervention before the onset of stimulation. Current diagnostics were within normal limits. Interventions taken indicated the patient was referred to speech therapy and otolaryngology, where he was diagnosed with vocal cord paralysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2336678


Title: Re: Voice/Speech
Post by: dennis100 on February 29, 2016, 06:23:45 AM
Model Number 103
Event Date 09/15/2011
Event Type Injury
Event Description
On (b)(6) 2011, a vns implanting surgeon reported that on (b)(6) 2011 the vns patient called their physician to report that he was experiencing pain in the larynx and had a hard time speaking. The patient was referred to the surgeon for generator re-positioning. The physician later reported that the patient was not experiencing any pain. The patient's hoarseness with stimulation was reported to be an expected side effect and that it occurred with stimulation. The physician stated that the patient was referred to an ear nose and throat physician, not a surgeon, for vocal cord evaluation. The physician reported that it is possible that preceding programming or medication changes may have contributed to the hoarseness. Clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient continues to have seizures but they remain mild. The physician also states that the vns helps via magnet but there are voice problems; otherwise the patient is doing well. The patient's settings were output=0. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec but the notes then say they are going to down adjust the vns. Review of the programming history reveals that the patient was then disabled that day to output=0ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1ma/magnet pulse width=500usec/magnet on time=30sec. Clinic notes dated (b)(6) 2011 reported that the patient is doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2284222


Title: Re: Voice/Speech
Post by: dennis100 on March 04, 2016, 12:05:42 AM
Model Number 303-20
Event Date 01/05/2016
Event Type Injury
Manufacturer Narrative

Event Description
Initially, it was reported that the patient was experiencing inaudible voice intermittently, hoarseness that goes away after a few minutes, pain in the neck and jaw and discomfort from device stimulation. It was reported that the physician was unable to titrate the device settings because the patient cannot tolerate the settings. It was later reported that the patient was admitted to the hospital for extreme pain related to device stimulation. The physician taped the magnet over the device to disable stimulation; however, the patient reported that the pain did not resolve and she could feel the device stimulating still. System diagnostics were run and were reported to be within normal limits. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5464399


Title: Re: Voice/Speech
Post by: dennis100 on March 06, 2016, 03:53:38 AM
Model Number 302-20
Event Date 01/01/2011
Event Type Malfunction
Event Description
It was reported that over the past several weeks, the pt complained of a tremble in her voice and feels stimulation as a foreign body in her throat. Pt denies any painful stimulation. The physician ran diagnostics and found high impedance and feels the lead is likely damaged. The pt underwent full revision surgery due to the high impedance. The explanted products were returned to the mfr, but analysis is pending. X-rays are being sent to the mfr for review, but they have not been received to date. Attempts for further info have been unsuccessful to date.

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=2227520


Title: Re: Voice/Speech
Post by: dennis100 on March 06, 2016, 03:54:05 AM
Model Number 302-20
Event Date 07/11/2011
Event Type Malfunction
Event Description
It was reported by a neurologist that a vns pt's voice turned into a whisper three days after it was increased from 0. 75ma to 1ma. Later, he was seen by another neurologist where system and normal mode diagnostics indicated high impedance. Pt's device was turned off. There was no report of trauma to the generator per pt's caregiver.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2219835


Title: Re: Voice/Speech
Post by: dennis100 on March 07, 2016, 03:08:32 AM
Model Number 304-20
Event Date 06/10/2011
Event Type Injury
Event Description
Rptr indicated a recently implanted vns pt developed "vocal cord issues" and was referred to an ent specialist for eval. The vns has not been activated yet. After the vns implant surgery, the pt experienced hoarseness, faint speech, coughing and difficulty swallowing. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2187882


Title: Re: Voice/Speech
Post by: dennis100 on March 08, 2016, 01:39:52 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported in a pt's clinic notes that the pt would like to have his vns battery removed. The pt recently ran the magnet over the device and felt no discharge, but the battery had been turned off, which had been confirmed by previous interrogations. The device had been disabled as it led to "voice changes and blood cough". The pt had initially tolerated the vns "rather well outside of some voice changes. However, given his seizure frequency at some time in the past, he ramped up the settings which caused him to have some hemoptysis". The pt did believe the vns to have helped his seizure frequency, and the physician admitted the seizure frequency had been lowered while on the therapy. A review of the pt's programming history revealed last known settings and diagnostics from (b)(6) 2008. The device was properly functioning at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2161859


Title: Re: Voice/Speech
Post by: dennis100 on March 08, 2016, 01:40:33 AM
Model Number 101
Event Date 06/07/2011
Event Type Injury
Event Description
A vns programming nurse reported to our country rep for the united kingdom that their vns pt has had a recent change to their seizures. The pt reports an increase in seizure activity over the last 3 months or so. Reported to be above their previous rate, but not a change in seizure type. The settings are current 1. 25ma, magnet current 1. 50ma with on time 30 seconds/ off time 5 minutes/signal frequency at 30hz and pulse width at 500 us. Eri/eos - no. Their device is still working after 10 years and 6 months and the pt's voice continues to be husky during stimulation - obvious in clinic (b)(6), 2011. The site is considering battery replacement but no date set at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155977


Title: Re: Voice/Speech
Post by: dennis100 on March 09, 2016, 03:01:48 AM
Model Number 102
Event Date 05/27/2011
Event Type Malfunction
Event Description
It was initially reported that the pt was scheduled for a full generator and lead revision. Add'l info was received indicating that the pt had been experiencing a shocking pain which started after he bent down to pick something up. The generator and lead were explanted and replaced. The lead and generator were returned to the mfr for analysis. Product analysis on the lead was completed. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, with no discontinuities identified. F/u with the neurologist revealed that the pt was seen on (b)(6) 2011 complaining of shocking sensation in his left neck, which he described as constant, starting two weeks prior to the visit after picking up his back pack. The reporter stated, however, that the pain was intermittently occurring and was not associated with stimulation. The pt was also complaining of dizziness when swiping his magnet, worsening voice alterations and coughing with stimulation. During that visit, the pt's device was interrogated and normal and sys mode diagnostics were performed. The diagnostics tests indicated that the device ws functioning properly and not at end of svc. The neurologist chose to refer the pt for a full revision because he felt that there was still some type of malfunction with the device, despite the diagnostic test results. The pt was disabled on (b)(6) 2011, had a full revision surgery on (b)(6) 2011 and the device was turned back on during an appointment on (b)(6) 2011. The pt's symptoms have resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2154184


Title: Re: Voice/Speech
Post by: dennis100 on March 11, 2016, 02:26:23 AM
Model Number 102
Event Date 05/02/2011
Event Type Injury
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103698


Title: Re: Voice/Speech
Post by: dennis100 on March 11, 2016, 02:26:54 AM
Event Date 04/21/2011
Event Type Injury
Event Description
It was reported via poster presentation entitled "vagus nerve stimulator in a pediatric population-surgical technique considerations in young children" that one patient experienced "dysphonia" and had vns setting decreased. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107192


Title: Re: Voice/Speech
Post by: dennis100 on March 12, 2016, 08:21:03 AM
Model Number 102
Event Date 04/18/2011
Event Type Malfunction
Event Description
On (b)(6) 2011, a vns treating physician reported that his patient was experiencing shocking from the device and the physician believes that there is a serious vns malfunction and that the leads need to be disconnected. The physician later reported that the patient has a history of manic episodes, pre-vns. The patient was implanted with vns due to chronic depression. The patient went off his medication and had a manic episode. The physician feels that the manic episode is the result of going off his meds, and not caused by the vns. He said that he saw the patient on (b)(6) 2011 and everything was fine. He said that, that evening the patient called him reporting that the vns shocked him and that his heart stopped, he couldn't talk, his neck muscles tensed. The physician saw him again on (b)(6) 2011 and the patient wanted the vns removed. The physician told him that he could not do that because he is not a surgeon. The patient said he did not want his implanting surgeon to remove the device, that he wanted a different surgeon. The physician does not know why he doesn't want his implanting surgeon to do the surgery. The patient's settings were at 0. 25ma/30/250/30/1. The patient cannot tolerate higher settings because it had made him hoarse in the past. The physician did not run any diagnostics because he said he wasn't sure if the device was malfunctioning and he didn't want to run diagnostics at a higher setting than the patient was used to. However, the physician had previously reported to the patient's consultant that he had run system diagnostics which showed everything ok. The patient then called the physician and told him that he cut the leads himself. The physician stated that the patient went into the hospital for a manic episode and they disabled his device. The physician said he has seen the wound that the patient made when he cut his leads. The physician does not know if the device "shocking" is really a device malfunction or due to the patient's mania. On (b)(6) 2011, the physician reported that the patient just called stating his vns is still shocking him event though it was supposed to be disabled at the hospital. The physician stated that he has not performed any diagnostics because he is afraid of doing it since the patient complains of it shocking. The physician doesn't know for sure, but he doesn't think the patient's generator was turned back on. The physician was told that if the patient was turned off then he should not be receiving any current from the generator. The physician said they are trying to schedule the patient with a surgeon for removal as soon as possible. He states the patient says the magnet is not keeping it turned off. The physician was told that if he had any problem to call back the manufacturer and he could be assisted to make sure the patient was turned off. The physician acknowledged that if he had any problems he could call the manufacturer; however, he has not called the manufacturer. The patient has been scheduled for surgery for device removal in (b)(6) 2011. When additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2109745


Title: Re: Voice/Speech
Post by: dennis100 on March 13, 2016, 03:02:33 AM
Model Number 300-20
Event Date 04/01/2011
Event Type Injury
Event Description
It was reported by a vns pt that after her prophylactic generator replacement on (b)(6) 2011, she started experiencing dysphagia, dyspnea, voice alteration and decrease perception of stimulation. Pt was instructed by surgeon to disable the device by placing a magnet over the generator. The dysphagia and voice alteration became less intense but they were still present. Pt reported that she was having difficulty breathing immediately after surgery as well. The pt saw a neurologist and he reported that adverse events of dyspnea, dysphagia and voice alteration were present even after the device was disabled. However, the treating neurologist did not know why the pt had a decreased perception of stimulation even though she was at her previous settings. Pt's last known settings were 1. 0ma/250usec/30 seconds and magnet mode of 1. 25ma/500usec/60 seconds. The system diagnostics were within normal limit (ok/ok/ok/dcdc=1/eri=no). The pt decided to leave her device 'on' and was advised to see an ent specialist. The treating neurologist believed that voice alteration may be related to intubation at the time of surgery. Later, pt notified the manufacture that she was admitted to emergency room and the attending physician and neurosurgeon examined pt's airways and believed that she has partial paralysis of the vocal cord. The device was turned off at that time. Good faith attempts to obtain more info regarding pt's vocal cord paralysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082993


Title: Re: Voice/Speech
Post by: dennis100 on March 19, 2016, 01:49:56 AM
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005793


Title: Re: Voice/Speech
Post by: dennis100 on March 21, 2016, 12:17:23 AM
Event Date 12/17/2010
Event Type Injury
Event Description
It was reported by a surgeon that a vns pt's mother indicated the pt experienced cough and could not talk. The surgeon indicated that the pt had been implanted approximately 1-2 weeks prior to the report. The surgeon further stated that the pt was programmed on to received therapy the following day after surgery. The manufacturer told the surgeon that per the manufacturer's labeling, it's recommended not programming the device on for 2 weeks after surgery to allow pt to recover from surgery. The surgeon agreed to contact the treating neurologist on the manufacturer's labeling as he programmed the pt on. Additional information was received from a company representative indicating the pt was experiencing extreme coughing and her voice was gone/having a hard time talking (voice alteration) since her implant on (b)(6) 2010. Additionally, the company representative reported that the treating neurologist had programmed the pt's device off due to the voice issues. In addition, the nurse at the neurologist's office indicated the pt had some numbness under chin above incision. Further information was received from the implanting surgeon indicating the pt was diagnosed with left vocal cord paralysis by an ent who was not familiar with vns therapy. 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=1963278


Title: Re: Voice/Speech
Post by: dennis100 on March 22, 2016, 02:24:37 AM
Model Number 102
Event Date 11/01/2010
Event Type Injury
Event Description
It was initially reported by the surgeon's nurse that the patient has been scheduled for a full revision surgery due to unknown reason. Follow up with the surgeon revealed that the patient was experiencing neck pain with vns stimulation approximately for 5 minutes. Patient was unable to swallow or talk during this time. Patient also had one episode of pain around her generator. Diagnostics showed everything working within normal; however, the treating physician felt it was necessary to replace the device. They suspected an intermittent dysfunction of vns system. The surgery was to prevent a serious injury as the pain was intense. No medication changes or trauma contributed to the onset of the event. Additional information received stated that the patient underwent a full revision surgery. Good faith attempts to obtain explanted products for analysis has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917817


Title: Re: Voice/Speech
Post by: dennis100 on March 28, 2016, 05:04:38 AM
Model Number 302-20
Event Date 04/22/2010
Event Type Injury
Event Description
It was reported to the manufacturer that the vns patient experienced inflammatory adenopathy (nodules) along the lead pathway. The nodes were noted upon palpation of the lead body. The patient is additionally experiencing dysphonia and a pulling sensation in the neck area. The patient has been scheduled to have a cervical ecograph performed. It was indicated that the reported event could be possibly related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702791


Title: Re: Voice/Speech
Post by: dennis100 on March 28, 2016, 05:05:07 AM
Model Number 302-20
Event Date 04/14/2009
Event Type Injury
Event Description
Our country representative in (b) (4) reported that a physician noted that he had a vns patient with inflammatory adenopathy (nodules) along the lead pathway. The nodes were noted upon palpitation of the lead body. The patient is additionally experiencing dysphonia and pain near the area of the nodules. The patient's lead impedance is reported to be not changing. Cervical ecograph identified that the patient had these nodules bilaterally in their neck region. Their treating physician at this time reports the event could be possibly related to their vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698797


Title: Re: Voice/Speech
Post by: dennis100 on March 28, 2016, 05:05:37 AM
Model Number 102
Event Date 03/23/2010
Event Type Injury
Event Description
It was reported that the pt was very upset as he was having severe hoarseness which was not resolving. Post implant he was put on very low settings for two weeks and the hoarseness was so severe that the physician turned off his vns and the pt was put on steroids for nine days. The pt reports that following all of this, his voice is still no better. Pt states he is unable to rest his voice for various reasons and is having multiple personal problems at this time as well. The voice alteration is not associated with stimulation as it is occurring even when the device is off. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692490


Title: Re: Voice/Speech
Post by: dennis100 on March 29, 2016, 05:35:46 AM
Model Number 302-30
Event Date 10/20/2009
Event Type Injury
Event Description
It was reported that the vns pt who had a new device (lead and generator) implanted in (b) (6) 2009 was experiencing constant hoarseness, not affected by stimulation of the device. The pt was eventually seen by an ent surgeon who evaluated the pt and stated the left vocal cord was not functioning. The surgeon stated that he does feel that the vocal cord issue is related to the replacement surgery that occurred in (b) (6) 2009. The pt has been going to speech therapy and continues to see the surgeon for follow up. The pt stated that despite the speech therapy she has been receiving, she does not feel there is any improvement to her voice. The device is programmed on and diagnostic testing performed on the device indicates normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1641398


Title: Re: Voice/Speech
Post by: dennis100 on March 30, 2016, 07:57:18 AM
Model Number 304-20
Event Date 01/13/2010
Event Type Injury
Event Description
It was reported that at the vns pt's first follow up visit with the neurologist following initial implantation of the vns device, the physician noted that the pt's voice was very raspy and was having a difficult time talking. The pt was seen by the implanting neurosurgeon at a postoperative follow up visit, where steroids were prescribed. The pt has an appointment with an ent specialist to evaluate the vocal cord movement as it is suspected that the pt may have had damage to the vocal cords from the implant surgery, however, the severity was unk. Device diagnostic test have been done since the device was implanted which indicate normal device function. It was noted that the implant surgery was a long surgery, lasting about 4 hours.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615209


Title: Re: Voice/Speech
Post by: dennis100 on March 31, 2016, 06:27:23 AM
Model Number 102
Event Date 07/01/2009
Event Type Injury
Event Description
Reporter indicated that the patient had experienced voice alteration and coughing in the past which would come and go. Eventually, however, the issues became constant, even with the patient's generator programmed off. The patient's treating neurologist recommended that the patient be seen by the ent physician. The patient was seen by an ent, who diagnosed the issue as left vocal cord paralysis. Attempts for further information from the ent have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575000


Title: Re: Voice/Speech
Post by: dennis100 on April 02, 2016, 03:51:36 AM
Model Number 102
Event Date 09/17/2009
Event Type Injury
Event Description
It was reported that a vns patient experienced severe pain with stimulation during night time. The patient reported that the pain has been so bad that he has turned the generator off using the magnet. Information from both the treating psychiatrist and patient indicated that vns has helped with the patient's suicidal ideations, but the recurring pain initiates suicidal thoughts. Furthermore, the patient is experiencing a different type of depression along with major voice alterations when vns stimulates. System and normal mode diagnostics were performed and resulted within normal limits. At the moment, settings were increased and no further interventions were done. Good faith attempts to obtain additional information from the treating psychiatrist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1504661


Title: Re: Voice/Speech
Post by: dennis100 on April 03, 2016, 01:57:48 AM
Model Number 102
Event Date 01/01/2006
Event Type Injury
Event Description
We received a call from an emergency room physician reporting that he had a vns patient in the er complaining of pain at the generator site, muscle spasms and voice alteration. The patient wanted to have their vns explanted and it was disabled in the er. The patient was seen for follow-up at their surgeon's office and when the patient came to see them, they were still having complaints of pain at the generator site. The patient is scheduled to have their vns explanted in 2009. No testing is available on the patient's vns as they have not been seen by any vns programming physician for a very long time. Good faith attempts have been made for additional details about the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1482973


Title: Re: Voice/Speech
Post by: dennis100 on April 04, 2016, 02:04:39 AM
Model Number 102
Event Date 04/01/2009
Event Type Injury
Event Description
It was reported that the vns pt's device was explanted with no plan for replacement. F/u revealed that the pt's device was explanted due to pain, coughing, voice tremor and discomfort from the stimulator. It was also indicated that the device was not re-implanted per pt's wishes. Good faith attempts to obtain additional info regarding the reported events have been unsuccessful to date. The explanted product has been returned to the mfr for product analysis. Product analysis has been completed on both the generator and the single lead portion. Based on the findings, there is no evidence to suggest a discontinuity in the lead which may have contributed to the reported allegation. The generator was found to be operating within designed limits and there were no performance or any other type of adverse conditions found. Note that since the electrode array section was not returned for analysis, an eval and resulting commentary cannot be made on that portion of the lead. No anomalies were identified that could have contributed to the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1430083


Title: Re: Voice/Speech
Post by: dennis100 on April 07, 2016, 09:54:32 PM
Model Number 105
Event Date 05/10/2012
Event Type Injury
Manufacturer Narrative

Event Description
Initially, it was reported that the patient was scheduled for explant due to unknown reasons. It was later reported that the patient experiences multiple side effects which were worsened after generator replacement in 2012. It was noted that the patient experienced dysphonia with device activation and dysphagia to pills. The patient also noted atrial fibrillation with seizures, submandibular tenderness, gastroparesis, left-sided breast pain and left-sided jaw pain. It was noted that the symptoms continued after programming the device off. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5526231


Title: Re: Voice/Speech
Post by: dennis100 on April 07, 2016, 09:55:24 PM
Model Number 100
Event Date 03/01/2016
Event Type Injury
Event Description
A mri technician inquired on the vns mri guidelines. During the call, the technician reported that the patient had her generator explanted several years ago due to voice alteration. It was reported that the patient is unable to get her implant information from the hospital because it was implanted so long ago. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5537803


Title: Re: Voice/Speech
Post by: dennis100 on April 08, 2016, 12:57:23 AM
Model Number 105
Event Date 02/24/2016
Event Type Injury
Event Description
The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016. At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri. But it is unknown if the device was disabled prior to mri or if the mri was performed. On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain. The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing. A nurse at the treating hospital requested that a company representative visit to turn the device off. A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode). Diagnostics were performed and reported to be within normal limits. It was unclear if the patient experienced a hear attack. Patient was asked to follow up with the neurologist once discharged. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5508303


Title: Re: Voice/Speech
Post by: dennis100 on April 09, 2016, 07:03:34 AM
Model Number 102R
Event Date 06/01/2009
Event Type Injury
Event Description
Attempts for return of the explanted vns generator and lead were unsuccessful as the hospital does not return explanted devices.

Event Description
It was initially reported by the patient that he "hates vns because it causes voice alteration. " the patient would successfully disable the device with his magnet, but wanted his physician to turn the settings since he felt they were too high. The patient stated that he was waiting for a return call from his physician. He later said that "he was going to jump off a pier and make all his problems go away. " the patient was told that he needs to contact his doctor immediately or go to the hospital. He stated he would contact his doctor. The patient was later contacted for further information on his situation. He indicated that he wanted his device removed due to voice alteration and he was frustrated due to the expense of the surgery. When asked for information on his treating physician he refused to provide the name. The patient stated that he was no longer seeing his psychologist and refused the case manager's attempt to send list of alternate physician names. Follow up with the patient's surgeon and past neurologist resulted in both currently not seeing the patient. No information could or was provided. Good faith attempts to obtain additional information have been unsuccessful to date. The relationship of the device to that of suicidal ideation is unclear at this time. The patient was also previously diagnosed as bipolar with depression.

Manufacturer Narrative
Analysis of programming history.

Event Description
It was reported to the manufacturer that the patient's vns generator and lead were removed on (b)(6) 2011 as the patient had brain surgery and no longer needed vns. Attempts for return of the explanted generator and lead are in progress.

Event Description
Manufacturer review of the patient's vns programming history noted device diagnostics were within normal limits near the time of the initial report of the suicidal ideations. The vns was later programmed off on (b)(6) 2010, and was not re-enabled after this date per the history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1407418


Title: Re: Voice/Speech
Post by: dennis100 on April 13, 2016, 08:34:39 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that a vns pt consulted an ear nose and throat physician due to hoarseness after the pt underwent an increase in device parameters. The ear nose and throat physician recognized a partial loss of movement in the pt's vocal cord. At the moment, the relationship of the partial loss of movement of the pt's vocal cord to vns therapy is unk as well as any pre-vns history of the event or relationship to stimulation. However, the pt stated that the event resolved with decreased settings of her vns device. 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=1393133


Title: Re: Voice/Speech
Post by: dennis100 on April 15, 2016, 01:40:12 AM
Model Number 101
Event Date 04/01/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was seen by the neurologist for a follow up appointment due to a recent onset of pain in the throat and dysphagia that occurs in the evening after taking medications orally, that would last for about three hours and a worsening or hoarseness during stimulation at times. At the follow up visit, the patient informed the neurologist that they had received diathermy administered by a physical therapist twice in the last two weeks. The physician was not able to perform diagnostic testing on the device as the patient was not able to tolerate the settings at which the test is performed. The physician programmed the device off, and referred the patient to an er for further examination. Additional information was received revealing that the diathermy treatment was to the foot, however further clarification is expected regarding the location of the treatments. Furthermore, it was reported that the patient was having a "change and an increase in seizures" following the diathermy treatment while the vns device was still on. The hoarseness has improved and the pain has resolved since the device was disabled, however the seizures worsened. The neurologist believes that there is a possibly that a problem with the generator is contributing to the change in seizures, throat pain, dysphagia, and worsening hoarseness events. The physician also reported that since "the diathermy treatment preceded the pain and dysphagia" another possible cause could be irritation of the vagus nerve, and the vns was turned off, these events improved. The patient subsequently was referred to a surgeon where the plan was to replace the generator, test the leads, and possibly replace them as well. The patient also had a pre-operative consult with an ent so that if there are additional issues with throat pain and dysphagia, the patient can be evaluated post-operatively as well. During surgery, the device was tested prior to explantation, and diagnostics revealed normal device function. The physician and surgeon opted to replace the generator. It was noted during surgery that there was serous "fluid in the connections and something was loose". The patient was seen by the neurologist's office post-operatively and they were able to turn the device on to 0. 25ma. Diagnostic tests revealed normal device function and the patient tolerated stimulation well. The patient's seizures have improved since the generator replacement. Attempts to obtain additional information are underway. Additionally, the explanted generator expected to be returned to manufacturer for analysis, however the device has not yet been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387031


Title: Re: Voice/Speech
Post by: dennis100 on April 19, 2016, 04:13:30 AM
Model Number 300-20
Event Date 01/26/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient presented at the treating physician office with hoarseness. The patient was seen by an ent and was diagnosed with left vocal cord damage. The device was disabled per the ent's recommendation and the hoarseness has improved. Good faith attempts to obtain additional information have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1363744


Title: Re: Voice/Speech
Post by: dennis100 on April 21, 2016, 02:37:22 AM
Model Number 105
Event Date 07/13/2014
Event Type Injury
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 because the patient was unable to disable her device. The patient was experiencing chest pain, voice alteration, and tightening of the chest. It was later determined that the reason why the patient was unable to disable her device with her magnet was likely due to improper technique. The patient stated she also had bradycardia while in the er. The patient¿s device was disabled, but the patient continued to experience voice alteration and shortness of breath. The physician stated that these issues were not related to vns. Ekg and ct were reported to be normal except for the bradycardia. The relationship between the bradycardia and vns is unknown. The patient was referred to see a cardiologist. The patient¿s device was disabled prior to being discharged. The patient¿s parent stated that the patient¿s blood work was abnormal; however, it is unclear what was abnormal with the blood work results. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Event Description
Clinic notes were received indicating that the vns patient was scheduled to undergo surgery on (b)(6) 2014 to explant her device. The patient had been hospitalized due to vomiting, diarrhea, sinus bradycardia, and voice hoarseness. The patient was given new medication and her device was disabled. It was noted that the patient¿s voice issues continued despite device disablement. The patient¿s device was tested and showed normal device function. The patient was seen by a cardiologist who determined that the patient had a history of nighttime bradycardia. The patient stated that she also had recently experienced bradycardia during the daytime. The patient had a history of chronic chest pain and was unable to tolerate stimulation at high settings due to the chest pain. The patient wanted her device explanted because it was uncomfortable and reportedly did not help with her seizures. Follow-up revealed that the patient¿s anxiety, nausea, voice alteration, vomiting and diarrhea were all related to vns stimulation. As the patient¿s device settings were increased, the patient¿s bradycardia had worsened and the patient was a non-responder to vns. The neurosurgeon stated that the patient did not have a prior history of cardiac events nor any pre-existing conditions susceptible to cardiac events. Additionally, the neurosurgeon indicated that the patient developed bradycardia following implant surgery. The patient underwent surgery on (b)(6) 2014 to explant her device. The explanted device has not been returned to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013497


Title: Re: Voice/Speech
Post by: dennis100 on April 24, 2016, 05:44:07 AM
Model Number 102
Event Date 02/03/2011
Event Type Injury
Event Description
It was reported in clinic notes dated (b)(6) 2010 that a vns pt was having a change in seizure pattern as the pt was experiencing more intense seizures and they were worse with stress. The pt further indicated that she had never had a convulsion. Additionally, the pt reported changes in speech, trouble with sleep and shortness of breath. Good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date. The pt currently underwent generator replacement surgery due to end of service as the generator was read at the following diagnostics in (b)(6) 2010 (system diagnostics ok, 2, yes). Good faith attempts to obtain the explanted generator have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2009639


Title: Re: Voice/Speech
Post by: dennis100 on April 27, 2016, 03:47:15 AM
Model Number 302-20
Event Date 03/01/2008
Event Type Injury
Event Description
It was reported that the patient's voice was extremely hoarse, and couldn't speak completely after since surgery. It was indicated that the patient didn't recover for a while, and after turning the device off, the patient started recovering her voice up to 85 percent. Follow up information from the doctor revealed that the patient had voice hoarseness since surgery, and it became worse after turning the device on. The physician also indicated that turning the device off helped the patient to recover her voice slowly. No additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1234996


Title: Re: Voice/Speech
Post by: dennis100 on April 28, 2016, 01:59:48 AM
Model Number 100
Event Date 05/01/2008
Event Type Malfunction
Event Description
It was reported that a vns pt's device had been turned off 4 months ago because it was not working. The pt does not want to be reimplanted with vns because he has been stable with vns programmed off. Previous reports had indicated the pt's physician was referring the pt for generator revision, but the pt no longer wanted vns therapy due to the voice alteration and hoarseness he was experiencing associated with stimulation. It is likely that the vns device will be explanted. Good faith attempts to obtain additional info have been unsuccessful to date.

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=1186536


Title: Re: Voice/Speech
Post by: dennis100 on April 29, 2016, 03:01:52 AM
Event Date 09/09/2008
Event Type Injury
Manufacturer Narrative
See scanned page.

Event Description
It was initially reported that the patient has experienced difficulty speaking since his implant in 2008. The patient was seen by an ent who gave the patient some medication which improved the patient's symptoms. The patient still has some difficulty speaking and swallowing. The physician believes that these symptoms are due to left vocal cord paralysis, and has recommended vocal cord augmentation as the next line of treatment. The patient's current neurologist has performed diagnostics which were all within normal limits, however, they did not have the specific data to share. Good faith attempts to obtain additional information from the patient's treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1209565


Title: Re: Voice/Speech
Post by: dennis100 on April 29, 2016, 03:02:25 AM
Model Number 303-20
Event Date 06/19/2008
Event Type Injury
Event Description
Initial reporter indicated that their vns patient had hoarseness since implant with their vns. Exploratory surgery was performed to see if the leads were correctly implanted. No issues with the leads were found. Diagnostics testing within normal limits. Lead impedance was 3644 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1169959


Title: Re: Voice/Speech
Post by: dennis100 on April 29, 2016, 03:02:58 AM
Model Number 102
Event Date 08/11/2008
Event Type Malfunction
Event Description
It was reported to the mfr, the vns pt's generator was delivering stimulation continuously. The pt experienced headache and voice alteration as a result of the event. The patient tired to use the magnet to stop the stimulation, but was unsuccessful. The patient visited the emergency room and used the hospital's magnet to turn the device off. (refer to mfg report no. 1644487-2008-02183) there was no seizure activity associated with these events. Good faith attempts to obtain additional info regarding the pt's events are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1157164


Title: Re: Voice/Speech
Post by: dennis100 on April 29, 2016, 03:03:34 AM
Model Number 302-20
Event Date 03/12/2008
Event Type Injury
Event Description
Reporter indicated a pt had developed left vocal cord paresis that was diagnosed by an ent physician. The pt's vns system was previously explanted for pt lack of efficacy. Reporter indicated the cause of the left vocal cord paresis was unk, but that the pt was experiencing dysphagia, dyspnea, and voice alteration prior to vns explant surgery. The reporter stated the pt has had vocal cord injection and speech therapy interventions for the left vocal cord paresis. The pt continues to have difficulty with hyperfunction of larynx and poor voice. The explanted devices were returned for product analysis. The lead and generator performed per specifications and no anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155248


Title: Re: Voice/Speech
Post by: dennis100 on April 30, 2016, 12:23:24 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that pt had vns explanted due to painful stimulation and voice alteration. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1080725


Title: Re: Voice/Speech
Post by: dennis100 on May 01, 2016, 03:35:07 AM
Event Date 04/27/2008
Event Type Injury
Event Description
Reporter indicated a pt's vns was disabled due to constant voice hoarseness and difficulties swallowing which had not resolved despite programming changes. Four days after the vns was disabled, the pt developed an elevated blood pressure and had dizziness. No pathological reason for the elevated blood pressure or dizziness has been found. Attempts for further information from the attending physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053271


Title: Re: Voice/Speech
Post by: dennis100 on May 01, 2016, 03:35:49 AM
Model Number 102
Event Date 12/14/2005
Event Type Injury
Event Description
Reporter indicated a vns pt experienced hoarseness and pain in the electrode field. The physician stated the events are definitely related to stimulation. The pt elected to have the vns therapy system explanted as a result of the adverse events. 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=1054088


Title: Re: Voice/Speech
Post by: dennis100 on May 02, 2016, 01:07:40 AM
Model Number 102
Event Date 04/10/2008
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient recently began experiencing random muscle spasms in the chest at the generator site. Additionally, it was reported that the patient was experiencing shortness of breath during the random muscle spasms, constant hoarseness, an increase in seizure activity, below pre-vns baseline, and migraine headaches 4 or 5 times a week. The physician performed normal mode, system, and magnet mode diagnostic tests following the onset of the events, and the results revealed normal device function. The physician subsequently disabled the device and the events have reported resolved. As a result, the physician has referred the patient to a surgeon to have the lead and generator replaced. Revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047205


Title: Re: Voice/Speech
Post by: dennis100 on May 03, 2016, 01:22:13 AM
Model Number 102
Event Date 11/01/2006
Event Type No Answer Provided
Event Description
Reporter indicated that she was experiencing "shocks" and an increase in migraines. Patient's device was turned off, however, the patient "neck still cramp up when she yawns. " it was reported that the patient had to tilt her head back in order to get the cramp out. In addition, the patient has previously experienced tingling sensations in the neck with device stimulation, voice alteration with stimulation, and protrusion of the lead body at the neck site. Patient indicated that she is considering removing the vns system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1010154


Title: Re: Voice/Speech
Post by: dennis100 on May 03, 2016, 01:22:59 AM
Model Number 102
Event Date 12/12/2007
Event Type Malfunction
Event Description
It was reported to manufacturer that the vns patient was experiencing constant voice alteration and the patient felt that the device was continuously stimulating. Further follow up with the treating physician revealed that the patient was also experiencing a constant coughing, pain in the throat, and pain when the patient stretches the head back. The physician subsequently turned the device off. The reported events did not subside immediately following disablement of the device, however, over time, the events did subside. The patient followed up with a surgeon for a consult and the patient's caregiver explained that the day the reported events began, the patient was playing at a playground and no specific trauma occurred, however, at that point the stimulation became painful in the neck and worsened over time until the device was disabled. At the surgical consult, system and normal mode diagnostic tests were performed and revealed normal device function with the near end of service indicator was no. The surgeon opted to replace the generator. Attempts to obtain the explanted generator for analysis have been made, but have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=977136


Title: Re: Voice/Speech
Post by: dennis100 on May 03, 2016, 11:51:39 PM
Model Number 102
Event Date 10/19/2007
Event Type Injury
Event Description
Reporter indicated that a pt's vns generator and lead were replaced due to pain at the generator site and voice alteration. Reporter also stated that, the doctor told the pt the generator had moved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=966654


Title: Re: Voice/Speech
Post by: dennis100 on May 04, 2016, 06:44:30 AM
Event Date 11/22/2006
Event Type Injury
Event Description
I had the vagus nerve stimulator implanted in 2006. Two weeks later dr. Turned the device on with the wrong settings. Side effects experienced were dizziness, suicidal thoughts, migraine headache, extreme tiredness, and anxiety. Throat restriction -voice alteration- was also a problem when the device was on. These side effects resulted in me making two trips to the local emergency room over a three day period. The supplied magnet was placed over the device to keep it shut off until it could be permanently shut off at a later date. Device was turned off by dr. One week after emergency room visits. No bad side effects have been experienced since the device was shut off. Dates of use: 2006. Diagnosis: recurrent major depression. Event abated after use stopped: yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=935323


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:50:54 AM
Model Number 304-20
Event Date 03/01/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient is reporting increased seizures, nausea, vomiting with magnet use, increased irritability, extreme voice hoarseness, left throat pain, and incisional pain over the generator. The patient was recently implanted on (b)(6) 2016. The device was turned on to 0. 25ma last week. She returned on (b)(6) 2016 with the above complaints and when system diagnostics was performed it resulted in high impedance over 10,000 ohms. X-rays also show that the generator lead coiled and disconnected from radiopaque structure in left supraclavicular area indicating disrupted vns. It was instructed to turn the device to 0. 0 ma and refer the patient to surgery for replacement. Clinic notes received on (b)(6) 2016 and dated (b)(6) 2016 state that patient believes seizures are worse since the operation. It was mentioned that the patient had a convulsion on (b)(6) and fell, hitting her nose and may have caused trauma to the device as she did mention she could feel it moving in her chest. Post-op symptoms (with device off) included weight loss, nausea, vomiting, increased headaches, and notable negative change in mood. The week prior she was initially activated at the output current of 0. 25 ma with minimal side effects. Over the past week, she has had significant reaction to the device with increasing hoarseness, left throat pain, incisional pain, worsened mood and nausea and vomiting with magnet use. Notes state that from her post-op convulsion, it is suspected that the disconnection of the lead and generator seen on x-rays is likely from her fall and will require surgery to correct the connections. Notes from initial implantation on (b)(6) 2016 also confirm that a non-absorbable suture was used to secure the generator to the pocket. Follow-up showed that the patient is referred for surgery on (b)(6) 2016. The voice hoarseness was stated to sometimes occur with stimulation on times. The left throat pain was occurring both with stimulation and without. It was stated that it is unknown if the increase in seizures is attributed to the high impedance but the level is approximately the same as baseline. It is unknown if the tinnitus, worsened mood, increased headaches, weight loss are attributed to vns therapy or high impedance. X-rays are not available for review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5551724


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:51:36 AM
Model Number 304-20
Event Date 03/14/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient's device showed high impedance. The patient is said to be located at a nursing home and it is unclear if there was any specific cause. There was no indication of the patient's generator being disabled. There are no known adverse issues at this time or causes of the impedance. It was noted that the vns device was interrogated on (b)(6) 2016 and a high impedance warning message was seen for >10,000 ohms. The patient does state that she is not able to feel the device running like it had been in the past but every now and then she has a weird sensation that there is a change in her voice. The patient was referred for replacement of the vns due to the high impedance but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5551851


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:52:01 AM
Model Number 103
Event Date 03/01/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported to cts that this patient wants to have his device explanted for an unknown reason. Good faith attempts to obtain the reason for wanting the device explanted were unsuccessful. The patient reported on (b)(6) 2016 that he is having spasms locally around the vns site left chest and neck area and vocal stimulation. He thought his vns was not functioning any longer. It was noted he also has svt with pvc cardiac issues. The patient scheduled a consult for vns removal. The patient stated his vns was turned off at the er visit and that there were no issues but was told it was most likely scar tissue causing pain. The patient noted he still does not have a neurologist but the surgeon will remove his vns without neurology approval. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5563700


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:52:36 AM
Model Number 103
Event Date 01/11/2016
Event Type Injury
Event Description
Further information was received indicating that the patient was seen by the physician on (b)(6) 2016. It was reported that the patient was doing well; the reported events have stopped. It was reported that the physician decided to increase the output current from 0. 75ma to 1ma. The device was tested and system diagnostics returned impedance results within normal limits with 3401 ohms.

Event Description
It was reported that a patient, recently implanted with vns, had side effects: a very trembling voice, sore throat and tingling sensations. It was reported that the device settings (frequency and pulse width) were modified due to those side effects, without success. It was reported that the patient has never had this event prior vns implantation. Programming history of the patient's device was provided to the manufacturer for review. It appears that on (b)(6) 2016, the device was programmed at output current 0. 75ma, pulse width 250-sec, frequency 20hz, on time 30sec and off time 5min. The device system diagnostic test was not performed. Additional information was received from the physician, indicating that the patient was implanted on (b)(6) 2016. The adverse events began when vns was turned on, on the implant date. It was reported that the patient started to have pain when the output current of 1ma was reached. This occurs during the on time, never during the off time. It was also reported that the voice alteration occurs whatever the output current value was, and during only the on time. The patient will be seen in clinic in mid-(b)(6). The impedance will be tested. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No additional information was provided to date.

Manufacturer Narrative
Udi number: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5566664


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:53:22 AM
Model Number 106
Event Type Injury
Event Description
It was reported that a patient who was recently implanted with vns, had a cough. The patient's cough sounded wet. It was reported by the nurse that they checked the lungs and all was clear, no chest infection. The cough was situated more in the upper airways. It was reported that antibiotics were prescribed but these did not work. It was also reported that the patient's voice sounded a bit deeper and possibly not as powerful. Additional information was received from the nurse, indicating that the device remained off at present as the constant coughing was causing additional pain to back and ribs (which has been longstanding) but exasperated. The patient is planned to see the neurosurgeon in clinic. The nurse indicated that she believed there was some laryngeal swelling with possible vocal cord palsy. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No additional information was provided to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5586499


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:53:49 AM
Model Number 302-20
Event Date 03/22/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient stated she was feeling pain and vocal changes when the device was stimulating. She said this started yesterday. Md checked her vns and ran system diagnostics, getting a high lead impedance warning message. This is likely the warning from the 24 hour auto measurement since when she ran diagnostics the impedance was 4638 ohms. It was stated that the patient's impedance back in (b)(6) was 2700 ohms and the physician is concerned that the patient may have a positional lead fracture (intermittent). The device was not turned off but was lowered to settings from 2. 0ma normal and 2. 5 ma magnet to 1. 0 ma normal and 1. 5 ma magnet. The patient did not want the device disabled all the way in fear that his depression would come back so the md only lowered settings. The md referred the patient to the neurosurgeon. Surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5582953


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:54:09 AM
Event Type Injury
Event Description
It was reported that a vns patient had some very pronounced voice alterations. It was reported by a nurse that when she had modified the device parameters, the patient's adverse event was solved. It was reported that the voice alteration has been entirely solved by changing the duty cycle. No additional relevant information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5607750


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2016, 03:54:39 AM
Model Number 103
Event Date 01/06/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient, recently implanted with vns, had side effects: a very trembling voice and sore throat. It was reported that the device settings (frequency and pulse width) were modified due to those side effects, without success. It was reported that the patient has never had this event prior vns implantation. Programming history of the patient's device was provided to the manufacturer for review. It appears that on (b)(6) 2016, the device was programmed at output current 0. 75ma, pulse width 250 sec, frequency 20hz, on time 30 sec and off time 5min. System diagnostics returned impedance results within normal limits with 3835 ohms. Additional information was received from the physician, indicating that the vns patient's device was implanted and switched on, on (b)(6) 2016. The physician reported that the reported events were related to vns stimulation as they caused to the patient the inability to speak. This event occurred every time the device was stimulating, whatever the intensity of stimulation was. But during the off time, the event disappeared. X-ray was taken and reviewed by the physician, who reported it to be unremarkable. It was reported that the device was turned off on (b)(6) 2016. The impedance value on that date was 4096 ohms. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5566669


Title: Re: Voice/Speech
Post by: dennis100 on May 07, 2016, 05:15:28 AM
Model Number 300-20
Event Date 01/01/2006
Event Type Injury
Event Description
Reporter indicated that, the patient was experiencing severe hoarseness at output currents above a certain level. Stimulation was lowered to mitigate the adverse event. The patient underwent an examination by an ent physician. The lowering of the output current was deemed to be intervention to prevent a permanent impairment. No vocal cord dysfunction was noted during the exam. An x-ray review was performed and the placement of the lead electrodes on the vagus nerve was believed to have been the cause for the event. The patient underwent generator and lead revision surgery. A portion of the lead was returned to the manufacturer and an analysis was performed. There were no anomalies found with the portion of the lead that was returned, but a complete analysis could not be performed, due to the electrode section of the lead not being returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=909400


Title: Re: Voice/Speech
Post by: dennis100 on May 08, 2016, 01:22:20 AM
Model Number 300-20
Event Date 01/01/2005
Event Type Malfunction
Event Description
Reporter indicated that systems diagnostics testing at an office visit resulted in high lead impedance readings, indicating a possible lead fracture. Reporter stated the patient felt regular stimulation and had observable voice changes. Review of x-rays by reporter did not reveal any obvious discontinuities in the ncp system. The patient later underwent a lead revision and generator replacement. The generator was replaced due to incompatibility with the new lead. The explanted lead and generator were discarded by the facility.

Manufacturer Narrative
Review of x-rays by reporter did not reveal any obvious discontinuities in the ncp system. 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=901544


Title: Re: Voice/Speech
Post by: dennis100 on May 08, 2016, 01:22:57 AM
Model Number 302-20
Event Date 12/01/2006
Event Type Injury
Manufacturer Narrative
X-rays were reviewed by manufacturer, and the strain relief bend and the placement of the electrodes did not appear to be per labeling recommendations.

Event Description
It was reported that a vns patient was experiencing pain at the electrode site which was exacerbated with stimulation and voice alteration associated with stimulation of the device. X-rays were reviewed by the manufacturer, and it was noted that the strain relief bend did not appear to be placed per labeling recommendations, but a strain relief loop and two tie-downs were noted in plce. Based on the formation of the strain relief bend, it is suspected that the anchor tether may not be attached to the vagus nerve. Additionally, the caudal (positive) electrode did not appear to be aligned with the cephalic (negative) electrode in the vertical fashion typically observed in x-rays. Follow up with the treating physician revealed that a systems diagnostic test was performed and revealed normal results. Additionally, no trauma was reported that could be causing the event. The device was subsequently removed and the explanted products were sent back to the manufacturer for product analysis. The laboratory analysis of the explanted generator was completed and revealed no anomalies and the device functioned as intended. The explanted lead is pending completion of product analysis. A new device was not re-implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=892309


Title: Re: Voice/Speech
Post by: dennis100 on May 09, 2016, 07:29:53 AM
Model Number 102
Event Date 02/07/2003
Event Type Injury
Event Description
Reporter indicated that patient was experiencing voice alteration and dysphagia that began after implantation of his vns therapy system, and had continually gotten worse. Reporter further stated that the patient's device was turned off for a period of 3-4 weeks, with no relief of the side effects. Subsequent follow up with the physician revealed that patient was "completely dependent on a feeding tube for all food and medication. " patient was subsequently referred to an ent specialist where it was discovered that "the patient's left vocal cord was a little weak. " manufacturer assessed x-rays of patient and it was noted that electrodes were implanted lower than what is normally seen. Good faith attempts to obtain further information are currently being made.

Manufacturer Narrative
Mfr assessed pt x-rays. Noted during assessment of x-rays that electrodes were implanted lower than what is normally seen.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=858278


Title: Re: Voice/Speech
Post by: dennis100 on June 05, 2016, 07:03:10 AM
Model Number 302-20
Event Date 12/14/2005
Event Type Injury
Event Description
Reporter indicated that vns patient continued to experience hoarseness and had to strain to speak in the evenings, approximately 15 days post implant. Stimulation had not yet been initiated. Treating physician indicated that at follow-up office vist 23 days post implant, the patient's voice had improved, but was still hoarse. The patient was referred to ent for evaluation. Stimulation was not initiated at this office visit. Report is incomplete, because device tracking information was not forwarded to manufacturer at the time of implant. Attempts to obtain it have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=669087


Title: Re: Voice/Speech
Post by: dennis100 on June 06, 2016, 01:12:18 AM
Model Number 302-20
Event Date 01/01/2006
Event Type Injury
Event Description
The reporter indicated that the lead electrodes were too small for the nerve, causing the patient to experience constant hoarseness. It was also reported that the vns system had not yet been turned on. Revision surgery was performed to replace the lead (2. 0mm) with a larger one (3. 0mm). During the revision surgery, fibroses was observed and the vagus nerve was found to be visibly inflamed. Following the replacement surgery, the patient's voice was better within two to three days. The hoarseness has reportedly resolved completely. No further complications have been reported to the manufacturer. The lead was returned and analyzed. Product analysis summary: continuity checks of the various lead sections were perfromed with no discontinuities identified. The condition of the lead portions returned is consistent with conditions that typically exist following an explant procedure. No coil breaks were found. No other obvious anomalies were noted. Based on the product analysis findings, there is no evidence to suggest an anomaly with returned portions of the lead which may have contributed to the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=672742


Title: Re: Voice/Speech
Post by: dennis100 on June 06, 2016, 01:12:53 AM
Event Date 10/07/2005
Event Type Injury
Event Description
Reporter indicated that the pt has experienced difficulty with his voice since implant. The pt has reportedly experienced constant hoarseness since the device was implanted. Investigation to date has been unable to determine whether the pt has been diagnosed with vocal cord paralysis. Report is incomplete because no response has been received to manufacturer's requests for additional info from treating physician. Additionally, device tracking info was not forwarded to manufacturer at the time of initial implant surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=674037


Title: Re: Voice/Speech
Post by: dennis100 on June 06, 2016, 01:13:58 AM
Model Number 304-20
Device Problem No Information
Event Date 07/13/2015
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the suspect device udi on the initial report.

Event Description
On (b)(6) 2015 the patient reported that her voice alteration, which she stated is not related to vns stimulation, has progressed since surgery to the point where she believes she has, at a minimum, partial vocal cord paralysis. The patient noted she also has severe pain when trying to speak. It was previously reported on (b)(6) 2015 that the patient experienced voice alteration and dyspnea following implant surgery on (b)(6) 2015. The patient went to the emergency room and received anti-inflammatories and albuterol. The issues resolved, and it is planned to turn on the vns on (b)(6) 2015. The patient later reported that she still has not yet gotten her voice back and since receiving vns she has been experiencing nausea while eating and it feels like there is "air in her chest". Good faith attempts for further information were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5242672


Title: Re: Voice/Speech
Post by: dennis100 on June 06, 2016, 01:14:51 AM
Model Number 105
Event Date 10/26/2015
Event Type Injury
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that the patient was having issues at school with following her assignments. It is believed by the caregiver that the patient is having increased seizures as well. Patient is also sometimes speaking with a lisp. Additional information was received that the cognitive changes appeared to have resolved with a therapy level adjustment. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5236894


Title: Re: Voice/Speech
Post by: dennis100 on June 07, 2016, 12:34:09 AM
Model Number 103
Device Problem No Information
Event Date 04/13/2012
Event Type Injury
Event Description
The physician's office reported that the patient will be undergoing a stress test and ekg and the physician is unsure of the relationship to vns at this time. No additional relevant information has been received to date.

Event Description
The patient reported that she was scheduled to see the surgeon for consult. She indicated that she needs two procedures at the same time. The patient reported that the other procedure she requires is cardiac related for possible stent placement. The patient reported that she had an abnormal ekg, but it may be related to her vns. The patient underwent surgical consult and was referred to a cardiologist. No known surgical interventions have been performed to date.

Event Description
It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation. Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine. At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down. Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015. The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure. The relationship of these events to vns therapy is unknown to the neurologist. Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck. Patient's vns was also reported to have moved due to loss of weight. The surgeon did not recommend any changes due to the migration. Notes also indicated that the patient's vagus nerve was impaired with hoarseness. No known surgical interventions have occurred to date.

Event Description
The physician reported that device diagnostics were within normal limits. The patient was encouraged to use the magnet more. The physician indicated that the device is working fine and that the seizures are at the patient's pre-vns baseline and that the patient feels she is still having seizures.

Event Description
The patient underwent generator replacement. The explanted generator has not been received for analysis to date. The physician reported that the patient underwent cardiology consult and a stress test and there was no evidence of abnormality. The physician believes a 3d echo was performed. It was reported that the ekg was ok.

Manufacturer Narrative

Event Description
The patient reported that she is still experiencing issues with her new generator. The patient reported that she is uncomfortable and it still hurts sometimes. The patient reported that she feels like it "jumps" around sometimes. The patient complained to the physician's office regarding erratic stimulation. The patient reported that vns isn't working. The patient reported that she is experiencing an increase in seizures and is concerned that something bad is going to happen to her. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225867


Title: Re: Voice/Speech
Post by: dennis100 on June 07, 2016, 12:35:34 AM
Model Number 103
Device Problem No Information
Event Date 12/08/2014
Event Type Injury
Event Description
On (b)(6) 2015 it was reported that on (b)(6) 2015 the patient's device would be explanted due to irritability/behavioral and constantly screaming. The parents requested removal. The patient's device was explanted on (b)(6) 2015 and product return attempts were made but the device has not been received to date. It was later clarified that the vns was disabled in (b)(6) 2015 as it was causing him to be irritable; the voice changes bothered him and was deterring him from doing well in school per the patient's parent. The physician reported that the events were first observed on (b)(6) 2015 but have occurred since placement. The screaming/irritability was not believed to be due to any sort of painful stimulation. The patient's device was turned off which resolved the screaming. The behavioral irritability/screaming is believed to be associated with stimulation. Although the patient's diagnostic results were requested, they were not provided. The patient's settings were noted to last be at an output of 0. 75ma and magnet output of 1ma prior to disablement.

Event Description
On 12/14/2015 product analysis was completed on the generator. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisabled bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the product analysis 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative

Event Description
On (b)(6) 2015 the explanted generator and lead were received for product analysis on 11/16/2015. Product analysis was completed on the lead. A portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis has not yet been completed on the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5226246


Title: Re: Voice/Speech
Post by: dennis100 on June 08, 2016, 02:01:28 AM
Model Number 102
Device Problem No Information
Event Date 09/22/2015
Event Type Malfunction
Event Description
It was reported the generator was discarded at the hospital after explant and is not expected to be received by the manufacturer for product analysis.

Manufacturer Narrative

Manufacturer Narrative
Adverse event or product problem; corrected data: this information was incorrectly reported on the initial mfr. Report. Outcomes attributed to adverse event; corrected data: this information was inadvertently left off of the initial mfr. Report.

Event Description
It was reported by the physician that the patient experienced an increase in seizures. It is unknown if this increase is below, at, or above pre-vns levels. It was noted after this "seizure flurry" the patient developed dysarthria and says "da" for "ya". It was noted the patient is difficult to understand.

Event Description
It was reported by the physician that the reported difficulty speaking was not related to vns or seizures and appeared more psychogenic (anxiety induced). It was verified by the physician that medications were increased to help control seizures. It was reported on the returned implant card that the replacement surgery took place on (b)(6) 2015 and the re-implant occurred prophylactically, near end of service/end of service = no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5163151


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2016, 01:12:25 AM
Model Number 102
Device Problem Device operates differently than expected
Event Date 09/05/2015
Event Type Malfunction
Event Description
The patient had generator replacement on (b)(6) 2015 due to pain. The explanted device was received by the manufacturer. However, analysis has not been completed to date.

Manufacturer Narrative

Event Description
Information was later received that near the time of the initial event, the patient was undergoing a procedure unrelated to vns when an anesthesiologist noticed some spots on her throat and referred her to an ent physician. The patient saw the ent physician sometime near (b)(6) 2015 and noticed that her vocal cords were not opening or closing like they were supposed to. Patient did not have any symptoms from this event. The ent physician did not take any intervention for this and told patient to come back in 6 months for a checkup. Additional relevant information has not been received to-date.

Event Description
It was reported that a patient was experiencing erratic stimulation constantly and tingling pain at neck/clavicle area. Diagnostics were performed and were within normal limits. The patient¿s generator was programmed off, but the pain persisted. The (b)(6) wants the device replaced due to the issue. The device remained programmed off. Per clinic notes from (b)(6) when the patient followed-up with her physician, the patient was seen in the hospital with pain in her neck and throat. The device stimulation caused ¿intense pain¿ in her throat. The patient was unable to speak and felt as if the device was ¿squeezing¿ her throat. After the device was programmed off, the patient reported that the squeezing sensation in her throat became ¿unacceptable stinging in the left neck¿. The magnet was taped to the patient in the hospital to stop the stimulation, but was unsuccessful.

Event Description
Analysis was completed on the generator. 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5118141


Title: Re: Voice/Speech
Post by: dennis100 on June 17, 2016, 01:47:04 AM
Model Number 105
Event Type Injury
Event Description
It was reported that a vns patient had presented several adverse events: hoarse voice, inability to talk during stimulation, gasps for breath at the end of each stimulation, poor quality of life, reclusive, no social life/relationship/job. It was reported that the events started in 2014 after replacement surgery. Additional information was received indicating that those events were considered as serious because they impacted the patient's quality of life. It was reported that the events were solved after the modification of the device settings; now there is a better seizure control and better quality of life. It was reported that no patient history of the events prior to vns implantation, and no medication changes occurred that could cause or contribute to the event. System diagnostics were reported to return normal impedance results with impedance value of 2907 ohms. The output current was programmed at 1. 75ma. Review of manufacturing records confirmed that both, the generator and the lead passed, all functional tests prior to distribution. No additional relevant information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5636447


Title: Re: Voice/Speech
Post by: dennis100 on June 17, 2016, 01:47:45 AM
Model Number 102
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported by a company representative attending a clinic visit that the patient experienced pain in their neck electrode. The patient stated it to occur when lying on their left side. There was no report of trauma or manipulation. Systems and normal mode diagnostics were performed and the results were ok/ok/dc=2/eri=no. The patient's settings were 1ma/25hz/250us/30s/5min, magnet mode, 0ma. It was reported by a company representative attending a clinic visit that the patient experienced pain in their neck electrode. The patient stated it to occur when lying on their left side. There was no report of trauma or manipulation. Follow-up to the physician revealed that the patient also had increased hoarseness and pain, stated to be constant even with the device turned on or off, and was not getting better. The device was disabled to attempt to resolve the hoarseness. It was reported by the physician on (b)(6) 2016 that the patient plans to have the device removed due to the neck pain and hoarseness. Later follow-up to the physic revealed that the removal is due to the vns having been turned off for months but is giving the patient neck pain and hoarseness. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5651579


Title: Re: Voice/Speech
Post by: dennis100 on July 02, 2016, 12:11:38 AM
Model Number 302-20
Event Date 02/01/2012
Event Type Malfunction
Event Description
It was reported to the manufacturer that the patient had high impedance on a system diagnostics test performed on (b)(6) 2012. It was indicated that the last acceptable diagnostics for this patient were performed in (b)(6), however no specific results were provided. The physician indicated that there was no trauma or manipulation to the device. The patient's device was disabled, and it was indicated that the patient would be sent for x-rays which would be provided to the manufacturer for review. The x-rays have not yet been received. The physician also noted that the patient had been experiencing headaches with stimulation and also painful stimulation at neck region for about (b)(6) prior to this report of high impedance. The patient was referred for and underwent a full revision on (b)(6) 2012. The explanted products will not be returned as the hospital's policy requires the hospital to keep explanted products for 7 years. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the physician on (b)(6) 2012. An x-ray assessment performed by the site was provided and indicated that no fractures were observed. This however cannot be confirmed as the x-rays have not been sent to the manufacturer. It was indicated that the patient was complaining of headaches, stomach pains, tingling in her neck and chest with vibrating in her voice. She was also complaining of being shocked with headaches. The patient's settings were provided. No additional information was provided.

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=2482832


Title: Re: Voice/Speech
Post by: dennis100 on July 03, 2016, 12:41:29 AM
Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Disability
Event Description
Reporter indicated that vns pt has experienced seven stroke-like episodes in the last two years, but that ct scans were done and showed that no stroke actually occurred during any of these episodes. The episodes, one of which the pt is currently experiencing, are characterized by slow speech and not being able to walk. Treating neurologist reportedly does not know what is causing these episodes. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist. Additionally, no response has been received to manufacturer's attempts to confirm whether the pt is still implanted with her original generator or whether she has undergone generator replacement surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=657865


Title: Re: Voice/Speech
Post by: dennis100 on July 08, 2016, 03:07:40 AM
Model Number 106
Event Date 05/13/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that following lead and generator replacement surgery the patient was experiencing almost continuous hoarseness and dysphonia. The physician believed that the patient was suffering from transient vocal cord paresis. The physician reported that the symptoms were related to the recent lead replacement surgery. A system diagnostics test was performed at a follow-up appointment and the results were normal. The patient was evaluated by an ent and it reportedly doing better. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5752448


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2016, 01:15:52 AM
Model Number 102
Event Date 04/19/2016
Event Type Injury
Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2016, 01:17:05 AM
Model Number 302-20
Event Date 05/09/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
The explanted devices was received on 06/02/2016. The generator performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portions and the reported allegations of; 'fracture of lead(s)' (lead section) was not confirmed. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed abraded opening the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw 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, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegation of 'fracture of lead(s)'.

Event Description
Patient underwent generator and lead explant due to voice alteration and coughing associated with vns stimulation. The surgery was reported to be for patient comfort and was not to preclude a serious injury. During the surgery on (b)(6) 2016, the surgeon noted a lead discontinuity. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5700121


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2016, 01:17:49 AM
Model Number 106
Event Date 02/18/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient was experiencing a shortness of breath, voice hoarseness, and painful stimulation in the neck after initial implant surgery. The reported voice hoarseness occurred immediately after implant surgery and was slightly worse when the device was programmed to 0. 25ma output current. The pain in the neck occurred with the patient was programmed on. The patient was reportedly programmed off immediately after surgery. In the first week of may, the patient had a tracheostomy due to the reported shortness of breath. It was also noted that the patient had a thyroid removed prior to vns implant surgery in (b)(6) and it was unclear if this surgery caused any of the symptoms. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5707285


Title: Re: Voice/Speech
Post by: dennis100 on July 16, 2016, 02:25:29 AM
Model Number 302-20
Event Date 07/14/2014
Event Type Injury
Event Description
It was reported that the patient was diagnosed with right vocal cord paralysis by an ent. The patient reported that the vocal cord paralysis is related to vns therapy because the device was programmed off for an mri and the patient's voice went back to normal. The patient speaks with a deep rasp and has to strain to be heard. No interventions have been taken to date. The physician reported that the relationship of the vocal cord paralysis to vns therapy is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4082216


Title: Re: Voice/Speech
Post by: dennis100 on July 19, 2016, 10:58:51 AM
Model Number 102R
Event Date 02/01/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the vns patient was experiencing hoarseness, shortness of breath, and throat pain. The patient¿s asthma had exacerbated at the time. The patient was given steroids and an inhaler and the symptoms resolved. The patient later reported experiencing pain at the lead site and pain from laughing and coughing. The patient also reported discomfort at night and began snoring. The patient and patient's mother reported hearing and engine-like sound coming from the patient's device at night. The patient refused to have her device settings adjusted but noted that she was not using her magnet due to discomfort. Further follow-up revealed that x-rays were later taken and confirmed proper placement of the generator and lead; however, they showed chest wall infection with consolidation of the left lower lobe that was affecting her breathing. The patient is expected to receive antibiotics and a follow-up x-ray. Attempts for additional relevant information were made but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800594


Title: Re: Voice/Speech
Post by: dennis100 on August 05, 2016, 08:55:17 AM
Model Number 105
Event Date 06/09/2016
Event Type Injury
Event Description
Additional information was received from the nurse indicating that the symptoms started on (b)(6) 2016. The nurse indicated they do not know if the left vocal paresis was resolved. It was reported that the patient is now feeling well.

Event Description
It was reported that a vns patient was having left vocal cord paresis and coughing with blood. Those adverse events were considered as serious. It was reported that the patient¿s device was switched off on (b)(6) 2016. Additional information was received from a nurse, indicating that the vns was programmed, for a small time, at the following settings: output current: 3ma ¿ frequency: 20hz ¿ pulse width 250sec ¿ on time: 7sec ¿ off time: 0,2min and magnet output current: 3ma ¿ pulse width: 250sec ¿ on time: 60sec. It¿s a duty cycle of 58%. It was reported that the symptoms improved before the vns was turned off. It was reported that the vns generator was turned on again on (b)(6) 2016 and the settings were programmed as follows: output current: 1. 5ma ¿ frequency: 20hz ¿ pulse width: 250sec ¿ on time: 30sec ¿ off time: 5min (it¿s a duty cycle of 10%). The lead impedance was within normal limit with a value of 2597 ohms. The patient does not show any symptoms with those new settings. It was also reported that the patient was having hoarseness but it¿s the same as when vns was turned off. Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5768563


Title: Re: Voice/Speech
Post by: dennis100 on August 05, 2016, 08:55:52 AM
Model Number 302-20
Event Date 03/30/2016
Event Type Malfunction
Event Description
It was reported that vns patient has severe hoarseness. The system diagnostics seem ok. The x-rays seem normal. They also did an evoked potential recording and it seems that the generator creates an irregular stimulation pattern; no indication of a defective lead is present. Through a decrease of the output current from 2. 25 ma to 1 ma the patient has an increase of seizures that was linked to loss of therapy as per the doctor. The physician has decided to replace the generator with an aspire sr and planned the surgery. The customer requested a reimbursement if the product analysis confirmed a faulty generator. The review of the generator's manufacturing records confirmed all tests passed for the device prior to distribution. The review of the received x-rays indicated that the lead pin is fully inserted into the generator block, no anomalies were observed on the assessed x-ray images (no neck x-ray was provided). The received programming history was reviewed from 07/01/2015 to 03/29/2016. Parameters data also indicated that the stimulation ok. The review of the available programming history did not reveal any anomalies. Magnet activations were reviewed from 11/01/2015 until 03/29/2016, it was observed that the patient used the magnet about 3 times a day. Follow up indicated that the patient underwent a surgery; the neurosurgeon found some moisture in the lead and decided not to replace the generator without replacing the lead or generator. As no lead was available as backup, the surgery was postponed. The generator was dislocated and re-fixated accordingly. It was also reported that an evoked potentials monitoring was performed after the surgery and this showed an abnormal result. The surgeon is planning to replace the generator and lead in the next time, no date is known at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5769215


Title: Re: Voice/Speech
Post by: dennis100 on September 09, 2016, 12:00:22 AM
Model Number 304-20
Event Date 07/25/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported by the np that the patient is experiencing voice alteration while the device is not stimulating. Patient's voice was normal when vns is stimulating. Patient did undergo a recent full revision surgery where they were likely intubated,. Diagnostically, the output current will be titrated down. The patient will also be told to use the magnet to disable therapy. Per implant card received from surgery on (b)(6) 2016, the impedance was marked ok. Additional information was received that the patient's voice alteration began around (b)(6) 2016. Patient had not experienced voice alteration prior to (b)(6) 2016. The voice alteration did not resolve with decrease in output current settings but vocal symptoms have been slowly improving. Patient's voice is not yet to baseline. The relationship between the voice alteration and vns is unclear as voice improves with stimulation and worsens during off time. The nurse practitioner though that it could possibly be side effect of intubation from recent surgery on (b)(6) 2016. Interventions were taken to preclude a serious injury as opposed to patient comfort additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5908032


Title: Re: Voice/Speech
Post by: dennis100 on September 09, 2016, 12:01:19 AM
Model Number 106
Event Date 12/22/2015
Event Type Malfunction
Event Description
It was initially reported by the by the patient that she was having painful stimulation and increase in seizures, dysphagia, and coughing. It was noted by the physician's office that the patient's increase in seizures were not above pre-vns baseline levels and that simple vns setting adjustments resolved the issues and were not considered as serious injuries. However, the patient called again reported painful stimulation, voice alteration, and the inability to turn vns settings up. Additionally, the patient stated she has a feeling of being hungover for 72 hours after every settings change, which is described as a post-ictal state, including symptoms of blurred vision, headaches, very tired and lethargic. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5889627


Title: Re: Voice/Speech
Post by: dennis100 on September 09, 2016, 05:28:19 AM
Model Number 106
Event Date 07/12/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that vns patient was admitted to the hospital due to vomiting, coughing and he has lost his voice since the surgery. Additional information was received that the patient is doing better now. The vns therapy was switched on. The patient was in the consultation for further adjustment of the vns parameters. It was reported that there was still no improvement in the patient's voice according to the father. Further follow up with the physician indicated that the side effect is most likely caused by the manipulation of the vagus nerve during the surgery. The physician reported also that the preimplantation laryngeal emg was not performed routinely, so the quality of the nerve before surgery cannot be estimated. In physician's opinion, there are no therapeutic interventions possible at this time. The evaluation of the vocal cords can be done in the future if the problem persists, but the patient will need general anesthesia for the procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5893134


Title: Re: Voice/Speech
Post by: dennis100 on November 28, 2016, 11:34:35 AM
Model Number 304-20
Event Date 10/12/2012
Event Type Injury
Event Description
It was initially reported that the patient had severe hoarseness since date of implant, and there was consideration at that time to refer the patient to ent for botox injection in the vocal cord area due to possible laryngeal nerve damage. Upon follow-up, it was reported that the patient saw the ent on (b)(6) 2016. The ent noted that the patient had an underlying sleep breathing disorder. The ent discussed that the patient had left vocal paresis that was likely due to the vagal nerve stimulator implant. The ent assessed that given that he is not having significant problems with his voice or airway, the ent recommended observation. Per the reported diagnostics, the device is functioning properly. It was also noted that the patient recently had a tonsillectomy and adenoidectomy, in which the left vocal cord paralysis was initially noted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6064969


Title: Re: Voice/Speech
Post by: dennis100 on November 28, 2016, 11:35:13 AM
Model Number 302-20
Event Date 08/24/2016
Event Type Injury
Event Description
Information was received indicating that the patient had voice alteration independent of stimulation. The surgeon indicated that the patient's nerve might have been cut during surgery on (b)(6) 2016. Stimulation was turned on (b)(6) 2016. Since then the patient's settings have been reduced to lower settings and autostim has been turned off for patient comfort. Diagnostics from (b)(6) 2016 were within normal limits. There was also report of drainage of pus at the neck incision site as well as pain. Blood tests were run and there was no sign of infection, but antibiotics were prescribed. The leakage increased when the patient laid down. In addition to the drainage at the neck site the generator was found to be protruding. There was also flushing and pain present around the generator site. No other relevant information has been received to date.

Manufacturer Narrative
Suspect udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6031171


Title: Re: Voice/Speech
Post by: dennis100 on November 28, 2016, 11:35:49 AM
Event Date 09/12/2016
Event Type Injury
Event Description
It was reported on 09/20/2016 that the patient is experiencing a sore throat and has been choking on his food. Other side effects since his implantation surgery include his voice altering. When he drinks he feels like it is going down his left lung. On 09/14/2016 he stated he got a fever of 103. 9. He went to hospital, and found he had aspiration pneumonia and was dehydrated. No fever now. Was taught how to swallow to prevent aspiration but still doesn't help him. He states voice is still scratchy and vibrating. No redness or heat. Full neck swelling is better but incision swallow and lump is still there. He feels like someone is squeezing his esophagus. When trying to speak, he has to push really hard and use a lot of effort to get sound out. He feels like the lead is super tight. It was reported on 10/04/2016 that the patient cannot talk due to his vns surgery. He said his voice is slightly better, best in morning and gets worse throughout the day. Has to push air very hard to get sounds out. He states that he feels that the wire is too tight. If turns head to right and can feel it pulling. Had swallow study - any liquid gets stuck in back of throat and has hard time getting down to stomach. He states sometimes it goes down in lungs and coughs it out. Immediately post op he says he was dehydrated because he couldn't swallow. And he had aspiration pneumonia. He did state a x-ray was done by neurosurgeon who told him it was placed correctly. Patient thinks the surgery damaged one of the nerves coming off the vagus nerve. That he cut too far toward the front of the neck and nicked a nerve. Ent said that he has left vocal cord paralyzed and could take 6mo to 3 years to recover, but may not improve. He also recommended that vns be taken out. The vns is currently not programmed on. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6028201


Title: Re: Voice/Speech
Post by: dennis100 on November 28, 2016, 11:36:33 AM
Model Number 304-20
Event Date 06/29/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
On 09/23/2016 information was received indicating that the patient had voice issues immediately after their initial vns placement surgery on (b)(6) 2016. The patient sought the opinion of an ent who stated that the patient had permanent damage to anatomy in the area. The ent believed the cause of the damage was the intubation that occurred during surgery. No other relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6034726


Title: Re: Voice/Speech
Post by: dennis100 on November 28, 2016, 11:37:10 AM
Event Date 10/06/2016
Event Type Injury
Event Description
Vagus nerve stimulator caused hoarseness of voice, bradycardia, hypotension, and vocal cord paralysis. (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6046663


Title: Re: Voice/Speech
Post by: dennis100 on December 08, 2016, 01:27:34 PM
Event Date 01/01/2010
Event Type Injury
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 ben unsuccessful to date.

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. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2017218


Title: Re: Voice/Speech
Post by: dennis100 on December 09, 2016, 09:32:07 AM
Model Number 105
Event Date 01/01/2016
Event Type Malfunction
Event Description
It was reported that the patient is experiencing painful stimulation and does not think that her vns is working. It is unknown why the patient believed the vns to be not working but vns stimulation on time was observed by case manager via phone as patient's voice changes with vns stimulation. The patient was advised to use the magnet to disable the vns for the pain and asked to visit the neurologist or er if pain continues. Additional relevant information has not been received to date.

Event Description
Information was received from the neurologist's office that the patient was last scheduled to be seen in (b)(6) but had not come in at that time. Patient had called the office later and scheduled an appointment in (b)(6) 2017. Patient also called during the week of (b)(6) 2016 regarding a disability card that was needed from the office but had not reported any issues concerning the vns at that time.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096578


Title: Re: Voice/Speech
Post by: dennis100 on December 09, 2016, 09:32:42 AM
Model Number 304-20
Event Date 06/29/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported on (b)(6) 2016 that this patient was admitted to (b)(6) that day (transferred from (b)(6)) who had a vns implanted in (b)(6) and upon awakening had hoarseness and cough and since then an ent told him he had a paralyzed vocal cord. His vns was turned on a few days later. His vns was interrogated upon his arrival. The normal and magnet mode were then programmed off. It is unknown what the cause of the vocal cord issues are. A voluntary medwatch mw5065529 was submitted for the vocal cord issues and bradycardia. Bradycardia was reported in medwatch report # 1644487-2016-02512. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096929


Title: Re: Voice/Speech
Post by: dennis100 on December 09, 2016, 09:33:17 AM
Model Number 304-20
Event Date 04/14/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had experienced persistent hoarseness and some loss of voice since implant surgery and that the surgeon believed the nerve may have been nicked or clipped during surgery. It was reported that the device was programmed on and the patient tolerated that well. No interventions were planned. The patient was seen for follow-up on 05/15/2015 at which time it was reported that the patient's voice returned to normal the prior weekend.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4796396


Title: Re: Voice/Speech
Post by: dennis100 on December 09, 2016, 09:33:47 AM
Model Number 102
Event Date 11/01/2007
Event Type Injury
Event Description
It was reported that the patient's mother felt the patient was less alert while on vns therapy. Further follow-up with the physician found that the patient had minimal speech output at baseline however the mother felt the patient was nonverbal with vns therapy. The changes in alertness that occurred during the implant of the patient's initial vns generator were reported in mfg report #1644487-2016-02638. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6100703


Title: Re: Voice/Speech
Post by: dennis100 on December 09, 2016, 09:34:31 AM
Model Number 303-20
Event Date 04/15/2016
Event Type Injury
Event Description
It was reported by the physician that he wanted to start the process of getting the patient's explant scheduled as the patient had been having issues for the previous 6 months. The patient's "issues" were later explained as having a tickling sensation in her throat, voice alteration, she thought that the lead had moved in her throat and was touching her vocal cords. The patient stated these events happened about 6 months prior to the initial report and that it occurred after she was choked by her boyfriend. It was noted that x-rays were taken and reviewed and the vns had not moved. The vns was checked and the device was working as intended as the diagnostics were within normal limits. The patient was scheduled for surgery. The patient later stated that she didn't want the vns explanted as it did help her; however, if something could be done for the lead issue, as in a lead revision or exploratory surgery, she would be up for doing that. The surgeon's office tried to call the patient to see if she still wanted to be scheduled for surgery, but the patient was not answering. Therefore, the surgeon's office stated they would leave her on the surgery schedule until they hear back. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

Event Description
It was noted the patient stated her voice had been raspy since the assault and that she believed the vns lead is touching her vocal cords. She also explained she thinks the lead wires have moved and she can feel them now touching her vocal cords and protruding in her neck which did not occur prior to the assault. Additionally, the patient stated that she notices the magnet does not stop her seizures any more like they did before the assault. The nurse practitioner followed up with the patient and it was noted there were no more issues or complaints with the vns. The vns lead issue the patient was having resolved and no more follow-up is needed. It was explained by the nurse practitioner that the patient is a bit dramatic and decided she does not want to have the vns revision at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6086942


Title: Re: Voice/Speech
Post by: dennis100 on December 13, 2016, 09:12:48 AM
Model Number 250
Device Problem Use of Incorrect Control Settings
Event Date 05/01/2009
Event Type Malfunction
Event Description
It was reported that the pt's settings were incorrect upon a recent interrogation. The company rep indicated that back in (b) (6) during an office visit, there were several attempts to perform diagnostics, but fault messages occurred. Eventually, successful diagnostics were performed and the pt's device was seen to be within normal limits. The company rep said that the physician performed a final interrogation prior to the pt leaving the office. There was no other known office visit or device programming following the office visit in (b) (6). Prior to interrogating the pt's device and noting the device settings had been changed, the pt was admitted to the hospital for an increase in seizures, which was said to be below the pre-vns baseline levels. It was also noted that at this time, the pt's mood was worsening, similar to how he was pre-vns. The parents and teachers additionally noted that the pt's voice was no longer changing regularly, which they said was when they could tell the device stimulating. The physician believes that the pt's increase in seizures and mood change were most likely due to the change in parameters that were lower than the pt's therapeutic levels. The pt's settings were changed at the recent appointment to the expected settings and is currently doing well. His medications were also increased prior to leaving the hospital. It is unk at this time when and how the pt's settings were changed. 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=1480187


Title: Re: Voice/Speech
Post by: dennis100 on December 14, 2016, 12:48:19 PM
Event Type Injury
Manufacturer Narrative
Navarrete, eduardo g. , et al. "vagus nerve stimulation (vns) for the treatment of pharmacoresistant epilepsy: the spanish experience. ".

Event Description
Reporter indicated that a patient's vns device was explanted due to transient vocal cord paralysis and severe hoarseness.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1007355


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2017, 07:43:17 AM
Model Number 302-20
Device Problem Fracture
Event Date 11/23/2016
Event Type Malfunction
Event Description
It was reported by a medical professional that a vns patient presented in clinic with hoarseness which has come on with stimulation recently. He also has high impedance upon system diagnostics. The patient reports he has had no falls and no impacts. The only physical activity he has performed lately has been lifting boxes at work. He does not attribute the current lead issues to any particular event. It was provided that when the patient moves his head to the left the lead impedance value was normal and the lead impedance value is high when his head is turned to the right. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6188111


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2017, 07:43:50 AM
Device Problem No Known Device Problem
Event Date 09/25/2016
Event Type Injury
Event Description
An article entitled "an interictal eeg can predict the outcome of vagus nerve stimulation therapy for children with intractable epilepsy" was received and reported that two patients experienced wound infections after implant surgery and had their devices removed early as a result. The article also mentioned that 6 patients had voice hoarseness and one patient had a cough, but there was no indication of these events being related to serious injuries. No further information was provided for the reported infections.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6200273


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2017, 07:44:22 AM
Model Number 102
Event Date 10/07/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported, through clinic notes, the patient had been referred for vns explant. It was explained the reason for the explant referral was due to the vns not being managed by any physician and the patient's voice is hoarse. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6168598


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2017, 07:45:05 AM
Model Number 304-20
Event Date 07/23/2016
Event Type Injury
Event Description
It was reported that a patient was having dyspnea and voice alteration. The symptoms occurred even between stimulations. Diagnostics were within normal limits. The physician decided to disable the device to see if the symptoms get better. The patient was still experiencing vocal cord problems even with the generator programmed off. The vocal cord issue did not start until later into the titration phase and did not resolve with the disablement, so the physician believed that the nerve was inflamed and wanted to wait and titrate the device up again. The patient later reported that her implant surgery took two times as long as it should have because the surgeon had difficulty implanting the lead. While in recovery, she choked on water and could not swallow. The patient lost a large amount of weight because she could not swallow food. She also reported that she was diagnosed by an ent with left vocal cord paralysis, spasms in the trachea and esophagus, and damage to the swallow and sensory nerves. Due to these issues, she could not talk, breathe, or sleep. The left side of her face was also reportedly paralyzed. The patient was having speech and swallow therapy, but she was told that this would not help. The physician considered disabling the patient's device to allow inflammation at the nerve to go down, but the patient was receiving efficacy from vns therapy. The physician decided program the patient's device to low settings for all modes of stimulation. No further intervention was taken. No additional information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6150194


Title: Re: Voice/Speech
Post by: dennis100 on January 14, 2017, 08:00:45 AM
Model Number MODEL 250
Event Date 07/24/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012, and the patient was identified. It was indicated that the patient was seen in their office on (b)(6) 2012. At that time it was noted that the patient's off time was changed to 60minutes and the pulse width was 500usec. The patient had been reporting voice alteration with stimulation, as well as pain in her neck with stimulation since her last appointment in (b)(6). At the appointment in (b)(6), the physician realized that a faulted system's diagnostic test had occurred and corrected the patient's settings. The patient's correct settings were provided by the physician.

Manufacturer Narrative
Report source - corrected data: the "report source" was inadvertently omitted from follow-up report 2. The correct report sources were health care professional and company representative. Date received by manufacturer - corrected data: the "date received by manufacturer" was inadvertently omitted from follow-up report 2. The correct date was (b)(6) 2013.

Manufacturer Narrative
Analysis of programming history.

Manufacturer Narrative

Event Description
Reporter indicated a patient's vns settings were changed to unintended settings following a faulted systems diagnostics test. A final interrogation was not performed. The settings were later corrected, but it is not known when the faulted diagnostics occurred, or when the settings were corrected. Attempts for additional information are in progress.

Event Description
Programming history from the date of the event was received. The patient's generator was interrogated on (b)(6) 2012, at intended settings. A system diagnostic test was then performed which failed. Per the available programming history, a final interrogation of the generator was performed which identified that the patient's settings had changed, however, they were not corrected. On (b)(6) 2012, the patient's generator was again interrogated as the un-intended settings and corrected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2798027


Title: Re: Voice/Speech
Post by: dennis100 on January 15, 2017, 02:12:29 AM
Model Number MODEL 250
Event Date 03/12/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient's vns programming history was reviewed. Faulted systems diagnostics tests occurred on (b)(6) 2009, and (b)(6) 2012. All settings were corrected except for on (b)(6) 2012, when a final interrogation was not performed. At the next visit on (b)(6) 2012, settings were 1ma/20hz/500pulsewidth/30sec on/60min off, which is indicative of a previous faulted systems diagnostics test. The settings were not corrected at this visit, which was previously reported by the physician. The vns settings were not corrected until the next office visit on (b)(6) 2012.

Manufacturer Narrative
Date of event, corrected data: the correct event date was confirmed from the vns programming history. Analysis of programming history.

Event Description
Reporter indicated a patient's vns generator was noted to be set to 0ma upon interrogation on (b)(6) 2012. The settings were corrected this day. At the previous appointment on (b)(6) 2012, vns settings were as intended upon initial interrogation. A systems diagnostics test was performed, but no final interrogation was done. It is most likely that the systems test faulted and changed the output current to 0ma. In addition, the patient no longer felt stimulation and her depression increased slightly to below pre-vns baseline level as a result of the loss in therapy. After the vns settings were readjusted, the patient experienced voice alteration and felt the vns stimulation. Attempts for programming history are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2680478


Title: Re: Voice/Speech
Post by: dennis100 on January 25, 2017, 02:23:07 AM
Model Number 103
Event Date 09/25/2009
Event Type Injury
Event Description
Reporter indicated that the patient was experiencing hoarseness and coughing consistently. The patient's treating neurologist refered the patient to an ent for further evaluation. The ent diagnosed left vocal cord paralysis, and also refered the patient for a second opinion to a second ent. It is currently unknown who the ent was who saw the patient, therefore, no attempts for further information have taken place at this time. Attempts to gather which ent the patient was refered to, from the patient's treating neurologist, have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574996


Title: Re: Voice/Speech
Post by: dennis100 on January 26, 2017, 03:48:50 AM
Model Number 302-20
Event Date 09/01/2009
Event Type Injury
Event Description
It was reported that the vns patient, who was initially implanted with the device in (b) (6) 2009, had initially experienced continuous hoarseness and coughing after the surgery. The patient was seen by an ent surgeon, where vocal cord palsy was diagnosed. The device has not been reprogrammed on at this time, and the patient plans on following up with the ent surgeon for further evaluation. No interventions were taken and the ent surgeon recommended waiting three months until programming the device on. The hoarseness has improved since the ent evaluation that took place in (b) (6) 2009. Device diagnostic testing was performed at a post-operative follow up visit which indicated normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1616533


Title: Re: Voice/Speech
Post by: dennis100 on January 26, 2017, 03:49:26 AM
Event Date 02/23/2009
Event Type Injury
Event Description
It was reported that the pt was complaining of hoarseness. The pt then went to an ent physician who stated that the vns could have caused some vocal cord paralysis. It is unk if the pt's vocal cords are actually paralyzed or not. Per clinic notes, the physician had increased the pt's output current around that time. On (b) (6) 2010, the pt's device was turned off. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617442


Title: Re: Voice/Speech
Post by: dennis100 on February 06, 2017, 04:25:58 AM
Model Number 304-30
Event Date 01/04/2013
Event Type Injury
Manufacturer Narrative

Event Description

Event Description
It was initially reported that the patient was experiencing a sore throat and was having problems with her voice which made it so she could barely talk following vns implant surgery. The patient was diagnosed with left vocal cord paralysis by an ent after being scoped. The patient also reported having trouble breathing and swallowing and felt like there was something stuck in her throat. The family was told that she had an adverse reaction to the vns surgery. The patient had her generator disabled and was given a steroid which did not help. The patient has been weak, tired and nauseous at times since the surgery. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2981130


Title: Re: Voice/Speech
Post by: dennis100 on February 06, 2017, 04:27:15 AM
Model Number 300-20
Event Date 01/29/2013
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected but has not been confirmed.

Event Description
Additional information was received from the treating physician's office on (b)(6) 2013. The physician stated that no x-rays were taken following this incident. The increase in seizures event was first observed on (b)(6) 2012. The patient has multiple types of seizures, and each of those seizure types had increased - complex partial most of all. The increase in seizures was at pre-vns baseline level, and was believed to be due to a loss of stimulation (therapy) following this incident. The aggression, anxiety, and suicidal ideations events were first observed on (b)(6) 2013, and were all believed to be related to a loss of stimulation (therapy) following this incident. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of aggression. It was also provided that the patient does have a medical history of aggression before being implanted with vns. Interventions taken for the aggression event included increasing medications. Also, it was noted that the patient lived at home with family for aggression and suicidal ideations. The suicidal ideations were above pre-vns baseline level. The increase in depression was at pre-vns baseline level, and was believed to be due to a loss of stimulation (therapy) following this incident. The date the increase in depression event was first observed was not provided. There was no relationship of the voice alteration event to vns. The date the voice alteration event was first observed was not provided.

Event Description
It was initially reported that patient presented high lead impedance during diagnostic testing performed during an office visit on (b)(6) 2013. At the time of the initial report, it was unknown whether the device had been programmed off and the physician was not aware of any trauma or manipulation to the device. The last good diagnostic results were obtained in (b)(6) 2012 which is also the last time the patient was seen by the physician. The exact diagnostic results were not provided. The patient was said to be experiencing an increase in seizures recently. Clinic notes were received on (b)(4) 2013 for an office visit dated (b)(6) 2013 where it reports that the patient is having more seizures and is having aggression issues as well as increased anxiety. The patient is also having voice alterations during the office visit. The patient has suicidal thoughts first thing in the morning but does not act on them. The patient's current settings were said to be 1. 75/20/250/30/1. 8/2/250/60. Five mg of zydis was added to the patient's medication regime and the patient's dosage of vibryd will be increased over the next three weeks. In notes dated (b)(6) 2013, the patient became anxious and may have experienced a seizure. The vns was said to not be working and would need to be replaced. The patient was having more anxiety and was also having thoughts of suicide however he would not act on them. It is most likely that the stress are due to issues with the patient's family and due to the increased stress, the patient is having mores seizures. The patient underwent full revision surgery on (b)(6) 2013 in which the lead and generator were explanted and replaced. A review of the device history record (dhr) for the lead was performed and no unresolved non-conformances were found indicating that the lead past all function and visual inspection criteria prior to shipment. Good faith attempts to obtain additional information on all the reported events have been unsuccessful. It is unlikely that the explanted devices will be returned to the manufacturer as the site does not typically return explants.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2979299


Title: Re: Voice/Speech
Post by: dennis100 on February 07, 2017, 01:48:20 AM
Model Number 302-20
Event Date 01/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.

Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.

Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.

Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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 generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248


Title: Re: Voice/Speech
Post by: dennis100 on February 07, 2017, 01:49:15 AM
Model Number 103
Event Date 10/16/2012
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the patient's seizures "worsened" after the patient's generator replacement on (b)(6) 2012. Additional information was later received which indicated that over the last several months, the seizures have been more frequent, both before the replacement (mfr # xxx) and after the replacement. It was also stated that the patient was recently having almost continuous eye blinking and several facial twitches. It was stated that the patient's vns was tested; however, the diagnostics results were not provided. To clarify what was meant by "worsened seizures", the physician stated that the patient's seizures increased above pre-vns baseline levels. In addition, it was restated that the patient experienced eye blinking which increased from 10 - 20 per day to almost constant eye blinking. The patient's facial twitches increased from one to two per week to one to two per day. There was no causal or contributory programming changes, medication changes, or other external factors which caused or contributed to the worsened seizures. It was stated that the cause was unknown. Interventions were taken to preclude a serious injury. These interventions included increasing the patient's settings and turning on the patient's vns after surgery. The patient continued to have seizures despite these interventions; however, they were improved with medication. It was stated that the patient's vns settings have stayed the same throughout these events with the battery replacement. Clinic notes dated (b)(6) 2012 stated that the patient had a two to three week period during which she was seizure free. Over the past month the patient had four seizures, with two occuring the last week before this visit. Most recently, the patient was found seizing in her bed in the morning. The patient was experiencing full body "quick twitches' which included extensive facial twitching. A noise started the patient and the overt seizure activity resolved. Per the notes, a second early morning seizure occurred as the patient was waking up. There was a quick session of rapid eye blinking that "morphed into full body twitches". This episode lasted eight minutes, which the patient's mother confirmed is about the time it usually lasts. On (b)(6) 2012 the patient had a ten minute episode involving face twitching and difficulty speaking. No diagnostic results were available. No other information has been provided.

Manufacturer Narrative
Description of event, corrected data: a reference was made to the manufacturer report number 1644487-2013-00464 in the initial mdr; however, the manufacturer report number that was referenced was inadvertently not included.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2970529


Title: Re: Voice/Speech
Post by: dennis100 on February 09, 2017, 02:11:08 AM
Model Number 300-20
Event Date 08/11/2005
Event Type Injury
Event Description
Reporter indicated that a patient had vns lead and generator replacement surgery performed on (b)(6) 2006, due to voice alteration with vns stimulation and dyspnea. Vns setting changes did not resolve the issues. The patient was also having shock-like sensations in the neck that did not correlate to vns stimulation. Vns diagnostics were reported to be within normal limits. The patient had no trauma and was not spastic. The patient was reported to be doing well following the vns replacement surgery. The reporter felt there could be some current leakage along the length of the lead causing the adverse events. The explanted devices were returned for analysis. No anomalies were noted with the returned lead portion that would affect device function. An opening was noted in the outer tubing. No anomalies were noted during the generator analysis, and the generator performed per specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2985786


Title: Re: Voice/Speech
Post by: dennis100 on February 10, 2017, 04:49:28 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 11/24/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient had their generator explanted due to the patient losing (b)(6) pounds since the device was put in. It was also reported the patient was experiencing hoarseness with more than stimulation. A replacement device was not implanted. Additional relevant information has not been received to-date. The explanted device has not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6261686&pc=LYJ


Title: Re: Voice/Speech
Post by: dennis100 on February 11, 2017, 02:11:32 AM
Model Number 302-20
Event Date 10/03/2011
Event Type Injury
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing a cough and hoarseness that was found on (b)(6) 2011. It was reported that the patient started feeling it soon after vns implant because of laryngeal recurrent nerve paralysis. It was stated that this was resolved on (b)(6) 2011. No further information was provided. Additional information has been requested from the physician but no further information has been received to date.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the paralysis was first observed soon after implant surgery on (b)(6) 2011. The physician believes the event is due to the vns surgery. The paralysis does not occur with stimulation. It was unknown if the patient had been evaluated by an ent. The patient does not have a medical history of this event prior to vns. The physician reported that the coughing and voice alteration were also soon noticed after the vns implant surgery on (b)(6) 2011. The physician believes they related to both stimulation and surgery. According to the physician, the coughing and voice alteration are associated with stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3028936


Title: Re: Voice/Speech
Post by: dennis100 on February 11, 2017, 02:12:21 AM
Model Number 302-20
Event Date 03/01/2013
Event Type Malfunction
Event Description
On (b)(6) 2103, it was reported that high impedance was seen during diagnostics on (b)(6) 2013. The patient was at rapid cycling, but the device was disabled. Follow-up showed that the patient was hit in the neck that may have contributed to the high impedance. X-rays were taken but have not been provided to date. A blc was performed with 4. 83 years remaining. Attempts for additional information have been unsuccessful.

Event Description
An implant card was received which indicates the patient underwent generator and lead replacement on (b)(6) 2013. The implant card noted the lead impedance was ok. Attempts to have the products returned for analysis have been unsuccessful to date.

Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Device failure is suspected but did not cause or contribute to a death.

Event Description
On (b)(4) 2013, it was reported that x-rays were inconclusive and that the patient was referred for evoked potential testing. Attempts for results and additional information have been unsuccessful. X-rays have not been provided for review.

Event Description
On (b)(6) 2013 it was reported that the patient was seen that day by the physician and when system diagnostics were performed a dcdc of 4 was observed with high impedance and neo=no. The patient was scheduled for surgery. Although surgery is likely, it has not occurred to date. It was stated that the patient¿s vns is disabled and the patient does not want it turned on at this time because he feels painful stimulation. It was stated that fibrosis is suspected but it has not been verified. It was reported that the patient had worsening epilepsy in late 2012 that led to the discovery of a malfunction of the vns, ¿which appears to correspond to a lead problem/vns contact, fibrotic¿. It was stated that stimulation is tolerated until 0. 75ma but the patient has a severe cough from 1ma. The patient¿s mother thinks the patient has a worse clinical condition since stimulation was stopped; a problem with language/speech. Therefore the patient was re-programmed to output=0. 5ma/on time=14sec/off time=1. 1min. The physician also reported that ¿after the fight, there was a lesion of the electrode (the onset of pain was very sharp)¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3029714


Title: Re: Voice/Speech
Post by: dennis100 on February 11, 2017, 02:13:04 AM
Device Problem Communication or transmission issue
Event Date 11/29/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient's device was last able to be interrogated in (b)(6) 2016. The patient's output current was adjusted to 2 ma and all other settings remained at the same level. Patient had been seen in (b)(6) 2016 but the vns was not interrogated during these visits.

Event Description
Clinic notes were received which indicate that the patient's generator was unable to be interrogated after multiple attempts and position changes. The patient was still experiencing stimulation related coughing and voice changes. A company representative and the physician attempted to interrogate the patient's device with a known good programming system and the physician's programming system on (b)(6) 2016 to no avail. Troubleshooting was performed on the physician's device and no issues were identified. No additional relevant information has been received to date. No surgical intervention has been reported to date.

Manufacturer Narrative
Corrected data: initial mdr inadvertently omitted information known prior to submission of the mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6223902&pc=LYJ


Title: Re: Voice/Speech
Post by: dennis100 on February 12, 2017, 09:09:08 AM
Model Number 102
Event Date 12/01/2012
Event Type Injury
Event Description
It was reported that the patient's device was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

Event Description
It was reported that the patient was going to undergo prophylactic generator replacement due to the patient having an increase in seizures and experiencing an unusual grand mal seizure in (b)(6) 2012 which may have fractured a couple of the patient's vertebrae. The patient's seizures have increased from six seizures per month to ten seizures per month. It is unknown whether the increase is above the patient's pre-vns baseline frequency. It was reported that the patient is no longer having typical voice change with stimulation and is no longer feeling the stimulation. The physician increased the output current on (b)(6) 2013 and he noticed the patient's voice change. The patient was seen on (b)(6) 2013 at which time the physician noted that the patient's voice change was no longer occurring and that the patient was no longer feeling device stimulation. The physician reported that settings were increased again and that the patient could feel stimulation again. The physician indicated that diagnostics resulted in eos = no and were ok. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. Attempts to obtain additional information have been unsuccessful to date. Attempts to have generator sent to manufacturer for analysis are underway; however, the device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023738


Title: Re: Voice/Speech
Post by: dennis100 on February 12, 2017, 09:09:40 AM
Event Date 03/01/2013
Event Type Malfunction
Event Description
On (b)(6) 2013 it was reported that the vns patient recently presented with a persistent voice change, which was confirmed to not be due to puberty, and was not the type of voice change that could be considered hoarseness with stimulation. It was a constant event. The patient's vns was checked and high impedance was observed with an impedance value of about 9000ohms; there appeared to be a lead fracture. The patient was referred to an ent surgeon and it was confirmed that the patient had vocal cord paralysis. The patient's settings were noted to be output=1. 75ma/pulse width=500usec/on time=30sec/off time=1. 8min. The patient's identity was not provided but it was stated that he was a (b)(6) male. Good faith attempts for further information from the nurse practitioner were unsuccessful.

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=3019027


Title: Re: Voice/Speech
Post by: dennis100 on February 12, 2017, 09:10:24 AM
Model Number 102
Event Date 02/20/2013
Event Type Injury
Manufacturer Narrative
Eval: analysis of programming history.

Event Description
Additional information was received that the patient wanted her device removed due to choking. Clinic notes were also received. Notes dated (b)(6) 2014 indicated that the patient requested removal of the vns device. The patient stated that the device did not help and had been off for quite some time. The patient has a chronic history of dysphagia and mild chronic hoarseness. An endoscopy procedure was performed, and findings showed normal results. Notes dated (b)(6) 2013 stated that the patient had dysphagia with her device removed. The patient had a goiter. A post-implant note dated (b)(6) 2006 indicated that the patient was seen one week post-vns implant with no history of hoarseness or dysphagia. The incision site was healing well. Solids and liquids. Symptoms did not include choking. A note dated (b)(6) 2013 indicated that the patient wanted the vns stimulator removed, and the device has been shut off for years. Follow up with the physician found that the patient was last seen on (b)(6) 2011, at which time her device was still on at a very low output current of 0. 25 ma. He stated that following that, the patient discontinued being seen and to his knowledge, the device was still on. The physician stated that if the device was programmed off, it had not been performed by him and based on the vns settings being so low, it is possible she was weaned off the treatment. Vns explant surgery is likely, but has not occurred to date.

Event Description
The patient reported that she has nodules all around where the generator is implanted, and in her neck and that she would like to try and find a physician to explant her device. The patient also reported that the nodules are in her throat and have been causing her to choke. The patient indicated that she has been seen by physician for the nodules and no contributory factor has been identified. Additionally, the patient reported that she has not been seen by her vns physician in a long time and that she feels the device never did any good for her. Attempts to obtain additional information have been unsuccessful to date.

Event Description
The patient underwent explanted on (b)(6) 2014. The explanted devices are not expected for returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3017951


Title: Re: Voice/Speech
Post by: dennis100 on February 13, 2017, 04:30:26 AM
Model Number 304-20
Event Date 08/24/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing voice alteration since having his vns lead replaced on (b)(6) 2011 and an ent physician had diagnosed the patient with left vocal cord paralysis. The patient was referred for surgery to correct the vocal cord issue. The patient's vns had previously been disabled for one month in (b)(6) 2011 to attempt to resolve the issue however this did not improve the hoarseness. Follow-up with the physician's office found that the surgery was completed on (b)(6) 2012. The site described the surgery as a "thyroplasty adenoid adduction for dysphonia. " the vns diagnostics were normal following surgery however specifics were not provided. A letter from the ent physician indicated that the patient was "pleased with the results" of the surgery. The patient does not have a medical history of vocal cord issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511636


Title: Re: Voice/Speech
Post by: dennis100 on February 13, 2017, 04:31:16 AM
Model Number 103
Event Date 12/07/2011
Event Type Injury
Event Description
It was reported via clinic notes received that the vns patient was experiencing increased seizures. It was also noted that the generator is now indicating end of service. A clinic note dated (b)(6) 2011 indicated the patient had been experiencing increased seizures with "up to 5 seizures in 3 to 4 days" and went to the local er. The patient was noted as having 15 to 20 seizures in a note dated (b)(6) 2011 however it was noted that the patient did not "think her seizures have increased since she has discontinued lamictal. " the patient's settings were re-adjusted at that visit to help with voice alteration after the "frequency of the vns stimulations" was increased at the prior visit. It was also noted that the zonegran was increased during this visit as well. In the clinic note dated (b)(6) 2012, the patient noted she had 5 seizures since the previous appointment on (b)(6) 2011. Diagnostics taken at that time indicated generator end of service per the notes. The diagnostic results were not indicated in the notes. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received from the physician indicating the increased seizures are not related to the vns. She indicated that although the seizures had increased, the overall seizure frequency was still improved from the pre-vns baseline. The physician stated that the vns was functioning normally. The physician indicated that she did not wish to provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2508189


Title: Re: Voice/Speech
Post by: dennis100 on February 14, 2017, 02:44:19 AM
Model Number 102
Event Date 02/28/2012
Event Type Injury
Manufacturer Narrative

Event Description
Information was received from the patient's treating physician. The patient's increased depression was reported to be related to the patient's loss of therapy and their low battery. Their depression was worse with their battery dead. The relationship of their suicidal ideation and their vns is unknown. Prior to the event no programming or medication changes were made. Their generator is at end of battery life and needs to be replaced. Insurance will not cover their replacement surgery at this time.

Event Description
Initial information was received that a vns patient would be scheduled for surgery as their device has been dead since the end of (b)(6). Surgery has not been scheduled at this time related to insurance issues. On (b)(6) 2011 office visit, the patient's device was unable to be interrogated and felt that their battery may be down very low. The patient noted that his speech does not become hoarse as frequently as usual, likely a sign their vns battery is dying. On (b)(6) 2011, the battery on his vagal nerve stimulator (vns) registered as in need of replacement. With vns therapy, the patient has experienced the best control of his depressive symptoms in combination with his current medication regimen. On (b)(6) 2012, there was a report that the patient is having suicidal thoughts. Reported that the patient is in fragile state and has made self harm statements. It is unknown if the patient has a history of suicidal thoughts and the relationship to their vns. It is unknown if related to their loss of therapy. Good faith attempts are underway to obtain further information. At this time, no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2499921


Title: Re: Voice/Speech
Post by: dennis100 on February 14, 2017, 02:45:05 AM
Model Number 102
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative
"type of report, corrected data: inadvertently did not include "30-day report" on initial report. ".

Event Description
On (b)(6) 2012 additional information was received when it was discovered that the patient had generator replacement surgery that day for prophylactic reasons. The explanted generator was returned to the manufacturer for product analysis on (b)(4), 2012. Product analysis is still underway and has not yet been completed.

Event Description
On (b)(6) 2012, a vns treating neurologist reported that the vns patient was admitted to a local hospital for cardiac catheterization in (b)(6) 2012 and that during the intubation process prior to the cardiac catheterization, the patient's heart stopped for 45 seconds or so. The doctors gave him cpr and brought him back. The neurologist stated that the doctors in the local hospital were concerned about whether the vns could contribute to his cardiac arrest. The neurologist did not believe that the vns played the single major role in the patient's cardiac arrest. The neurologist stated that the patient went for a second trial of cardiac catheterization and had a stent for his coronary artery (70% stenosis). The neurologist said that he promised the patient that he will turn off the patient's vns temporarily for his future elective surgeries. The patient has been referred to a surgeon for replacement of his vns battery, which was already planned prior to the cardiac arrest. Since the cardiac arrest in (b)(6) 2012, the neurologist stated that patient's voice has become very hoarse with vns stimulation and he has started to feel pain occasionally with vns stimulation. The neurologist reported that they already suspected his vns might be close to the time of end of life but the vns diagnostics did not show that. The neurologist stated that the patient's leads need to be inspected and possibly revised as well. Additional information was requested from the neurologist but he stated that he did not wish to provide any further information. Although surgery is likely, it has not yet occurred. A battery life calculation was performed with the programming history available which showed negative years until the elective replacement indicator reads as yes.

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis 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 elective replacement indicator (eri) was set; the battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2503387


Title: Re: Voice/Speech
Post by: dennis100 on February 15, 2017, 02:44:16 AM
Event


Title: Re: Voice/Speech
Post by: dennis100 on February 22, 2017, 02:29:18 AM
Model Number 300-20
Event Date 07/19/2000
Event Type Injury
Event Description
The patient had their vns implanted in 2000 and at that time it was reported they had post implant hoarseness lasting 6mths, direct laryngoscopy identified, vocal cord paresis. Since that time the patient's voice has recovered and no further vocal cord examinations since that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1349717


Title: Re: Voice/Speech
Post by: dennis100 on February 24, 2017, 01:21:58 AM
Model Number 302-20
Event Date 07/11/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a neurologist that a vns patient experienced coughing, hoarseness, and difficulty swallowing after his vns settings were increased from. 75 ma to 1 ma. The treating physician indicated the patient then experienced vocal cord paralysis and the patient has not recovered. Moreover, the neurologist indicated that when the patient had vns explanted due to high impedance (mfr report # 1644487-2011-01816), the surgeon saw that the superior electrode had been pulled partially from the nerve and the tissue was scarred. The patient's mother indicated the patient did not have a physical injury that could have contributed to the event. At the moment, good faith attempts to obtain further information regarding the event have been unsuccessful to date.

Manufacturer Narrative
Correction: patient identifier was inadvertently reported incorrectly on the initial medwatch and has been corrected. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2372099


Title: Re: Voice/Speech
Post by: dennis100 on February 24, 2017, 01:22:46 AM
Model Number 102
Event Date 10/01/2008
Event Type Other
Event Description
My son has microcephaly with spastic quadriplegia. He is nonverbal and requires total care. He had increased seizure activity while in the hospital for spinal rod placement, and his vagal nerve stimulator was "turned up" to try and help with this. He went home uneventful and in fact a day early and had 2 more visits to the neuro for adjustment of the vns. By approx two months later, pt developed severe breathing problems, erratic heart rates 45-152/min, loss of his voice when he cried and profuse sweating. He ended up requiring constant nasal oxygen with a nonrebreather at times. He now also requires cpap at night and daily breathing treatments. I taped the magnet onto the vns the following month to shut it off, because his doctor didn't believe it was the vns. If i hadn't of done this, my son would be dead today. I am a rn and am appalled at the lack of caring and knowledge r/t this device. I took him back to the surgeon that put it in and he turned the device down to the original settings. At the highest point, it was on for 30 sec and off for. 8 min with 2. 5 amp. It is now on for 30 sec and off for 5 min at 1. 75 amp. Dates of use: 2007 -- 2008. Diagnosis or reason for use: seizures. Event abated after use stopped: yes. Event reappeared after reintroduction: no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1276206


Title: Re: Voice/Speech
Post by: dennis100 on February 26, 2017, 01:14:44 AM
Model Number 302-20
Event Date 09/01/2008
Event Type Injury
Manufacturer Narrative

Event Description
Reporter indicated that she was experiencing hoarseness postoperatively. She went to see an ent, who did video monitoring of her vocal cords and found that her left vocal cord had been paralyzed. At the time of this report, the vns was not programmed on. No trauma to the vagus nerve was reported by the implanting surgeon to have occurred during surgery. All attempts for more info were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1291933


Title: Re: Voice/Speech
Post by: dennis100 on February 26, 2017, 01:15:36 AM
Event Date 02/01/2003
Event Type Injury
Event Description
Reporter indicated that a vns patient presented voice alteration immediately after device implantation surgery. Upon medical examination, it was found that the patient's left vocal cord was immobile. The follow up seven months later revealed minimal activity of the left vocal cord which would possibly demonstrate early recovery of the vocal cord paresis. The reporter indicated that the patient's device was programmed on and the vocal cord paresis did not appear to be affected by device stimulation. Good faith attempts to obtain additional information such as patient implant information have been unsuccessful to date.

Manufacturer Narrative
Laryngopharyngeal dysfunction from the implant vagal nerve stimulator. Zalvan, c. Et. Al. The laryngoscope 113. February 2003: pp. 221-225.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1289413


Title: Re: Voice/Speech
Post by: dennis100 on February 28, 2017, 09:03:40 AM
Event Date 01/01/2006
Event Type Injury
Manufacturer Narrative
Ghanem, tamer and early, stephen; vagal nerve stimulator implantation: an otolaryngologist's perspective, otolaryngology-head and neck surgery; 135. 46-51. 2006.

Event Description
It was reported in an article file tracking patients implanted between 2002 - 2005 at a hospital that one patient presented voice change during stimulation and endoscopy revealed an immobile left vocal cord independent of device stimulation. The patient did not have any dysphagia or aspiration symptoms. Rigid videostroboscopic exam without stimulation revealed that the patient had an immobile left arytenoid, reinke's edema in the left vocal cord, with good glottic closure during adduction. Good faith attempts to obtain additional information from the author, including information on whether or not this event had been reported to the manufacturer previously, have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581538


Title: Re: Voice/Speech
Post by: dennis100 on March 01, 2017, 02:07:29 AM
Model Number 102
Event Date 05/17/2006
Event Type Injury
Event Description
A vns patient initially reported that he has constant hoarseness since implantation of his vns (not occurring with stimulation). He also stated that since (b)(6) 2008, he gets nauseated, has acid reflux and, has left thigh pain. Magnet use does not relieve any of these symptoms. Patient stated that his device was turned off in 2007 for almost a year but still experienced voice hoarseness. He chose to turn the device on in 2008 as his depression was increasing. On (b)(6) 2010, he reported to the manufacturer that his vsn device has been turned off since (b)(6) 2008 because his vocal cord was partially destroyed. Good faith attempts to obtain more information about patient's voice hoarseness and vocal cord status have been unsuccessful to date since psychiatrist needed an authorization for release of information from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1966132


Title: Re: Voice/Speech
Post by: dennis100 on March 01, 2017, 05:36:40 PM
Model Number 302-30
Event Date 08/03/2007
Event Type Injury
Manufacturer Narrative

Event Description
Reporter indicated a vns patient developed left vocal cord paralysis due to initial vns implant surgery performed on (b)(6) 2007. The patient had a silastic implant in the left vocal cord performed in 2008, and recently had this replaced with a gore-tex implant. The patient also had left vocal cord medialization surgery performed on (b)(6) 2010. The patient can now project her voice and speaking is not as tiring, and her voice has much improved but is still hoarse. The patient has excellent mobility currently with both vocal cords, with complete glottic closure. The patient's vns was disabled on (b)(6) 2009, due to neck pain, and the generator and most of the lead was explanted on (b)(6) 2010, due to pain in the chest (reported previously via mdr # 1644487-2010-02741). All attempts for return of the explanted lead and generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953677


Title: Re: Voice/Speech
Post by: dennis100 on March 01, 2017, 05:37:19 PM
Event Date 12/07/2010
Event Type Injury
Manufacturer Narrative

Event Description
Reporter indicated a vns patient was hospitalized due to having painful stimulation in the neck. No known trauma occurred. The patient was hospitalized to preclude a serious injury per the reporter. The vns was disabled, but the patient continued to report, she felt painful stimulation and was observed to have voice alteration with the reported stimulation. The patient had the vns settings increased slightly three days prior to the painful stimulation occurring. The patient later had generator replacement surgery only due to the painful stimulation; the original lead was not replaced. Since the surgery, the patient's new vns generator has been turned on and the patient is no longer experiencing any painful stimulation. Attempts for return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953644


Title: Re: Voice/Speech
Post by: dennis100 on March 02, 2017, 12:41:57 AM
Model Number 102
Event Date 09/09/2003
Event Type Injury
Event Description
On (b)(6) 2012 a vns treating neurologist reported that the vns patient has been experiencing chest pain and voice alteration with stimulation since (b)(6), 2003. The device was disabled on (b)(6) 2003. No causal or contributory programming/medication changes preceded the onset of the events. No patient manipulation or trauma occurred. The physician stated that the device will be removed per patient request. Although surgery is likely, it has not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2430061


Title: Re: Voice/Speech
Post by: dennis100 on March 02, 2017, 02:37:38 AM
Model Number 101
Event Date 10/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had battery replacement surgery on (b)(6) 2012. Good faith attempts for the return of the explanted generator to the manufacturer for product analysis were made but it has not been received by the manufacturer to date.

Event Description
On (b)(6) 2011, clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing an increased seizures activity over the past month. The patient previously had 1-3 seizures per month, but recently the patient was having 1-3 per week. The patient's vns settings were then adjusted. Clinic notes dated (b)(6) 2011 state that the patient had three seizures since the (b)(6) 2011 appointment. The patient's mother also reported that since the patient's vns settings were adjusted, the patient has not been feeling well, has hoarseness of throat, restlessness at night, and appears to have pain in the throat and ear regions in the mornings. The physician then referred the patient for battery replacement as the battery was believed to be at end of service. Good faith attempts for further information from the physician have been made but no additional information has been received to date. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2421270


Title: Re: Voice/Speech
Post by: dennis100 on March 02, 2017, 02:38:42 AM
Model Number 302-20
Event Date 12/27/2011
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, product analysis on the returned generator was completed. The generator was explanted/returned for "prophylactic replacement. " visual examination noted tool and burn marks on the generator can, most likely associated with electrocautery procedures, and manipulation of the device during the explant procedure. Visual assessment of the septum revealed damage as result of the setscrew being backed out excessively. The device was continuously monitored for 25. 25 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. On (b)(6) 2012, product analysis on the returned lead was completed. A break was identified in the negative coil. Pitting or electro-etching conditions occurred at the break location. The fracture mechanism cannot be determined. No other anomalies were identified in the returned lead portions. On (b)(6) 2012, additional information was obtained regarding the patient's condition. It was reported that the high impedance and voice alteration were first observed in (b)(6) 2011. No x-rays have been taken. No patient manipulation or trauma is believed to have caused or contributed to the lead fracture. The increased voice alteration is attributed to the lead. In the beginning, the vocal change was occurring with stimulation.

Event Description
It was reported via clinic notes received that the patient was having surgery vns lead replacement due to high impedance. The patient was noted has having an excellent response to vns therapy including being able to resume school, driving, and work. The patient was noted as experiencing more vocal changes with stimulation. While returning the explant lead and generator, it was indicated that a lead fracture was observed during surgery. The explanted lead and generator have been returned and are currently undergoing analysis. An implant card and the return product form also indicate that the lead was fractured. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2429935


Title: Re: Voice/Speech
Post by: dennis100 on March 02, 2017, 02:39:27 AM
Model Number 101
Event Date 09/03/2010
Event Type Injury
Event Description
It was initially reported that vns pt was being reimplanted due to eos. After the generator was received by mfr, the product analysis results showed that the generator had 4. 60 yrs left to eri=yes. According to product analysis, the device performed according to mfr's functional specifications. Further f/u with pt's treating neurologist revealed that pt was having voice alteration and increase in seizures. It appeared from clinic notes that pt was referred for vns generator replacement due to clinical end of svc. In the clinic notes, it is mentioned that vns therapy has helped with petite mal seizures but not grand mal seizures. There was no prior programming changes prior to increase in seizures. However, the neurologist tried different medication such as keppra and lamictal xr to observe the seizure rate while the vns generator was turned off. After vns replacement, pt had complex seizures during his stay at the hospital over the next 2 nights and the treating neurologist increased his medication, vimprat, to 200 mg twice a day which was tolerated well with the pt. Pt did not have any seizures the night prior to getting released. Further f/u with the neurologist revealed that the pt pre-vns seizures were unk and the pt hasn't been seen by a neurologist after implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956357


Title: Re: Voice/Speech
Post by: dennis100 on March 02, 2017, 02:40:11 AM
Model Number 103
Event Date 11/30/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that an error message was received with diagnostics were run on the pt. A company representative came to the site to troubleshoot the issue. The warning message and result were duplicated by the company representative on her programming system. A generator reset was perform and appeared to correct the issue. The patient's previously programmed parameter cause painful stimulation, hoarseness and tingling which it has not done before. Pt was programmed to lower output current to allow them to adjust to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956837


Title: Re: Voice/Speech
Post by: dennis100 on March 03, 2017, 08:54:52 AM
Model Number 304-20
Event Date 03/16/2011
Event Type No Answer Provided
Event Description
Reporter indicated the patient may be seen by a neurosurgeon for evaluation of the patient¿s neck at the patient¿s request, but no surgery date has been set. The reporter declined to provide additional information.

Manufacturer Narrative
The event of the patient's worsening asthma was inadvertently omitted from the initial mdr report.

Event Description
Clinic notes from the new treating physician were received indicating surgery to replace the vns generator and possibly the lead may be done in order to relieve the patient's symptoms of voice alteration, dyspnea and painful stimulation. It is suspected the lead placement may be the cause of the patient's adverse events. A surgery date has not been set. Attempts for additional information are in progress.

Event Description
Rptr indicated that since she was implanted with the vns in (b)(6) 2011, she was experiencing vocal cord paralysis when the vns would stimulate. The rptr stated she had a bronchoscopy performed and it was confirmed the left vocal cord had "some sort of paralysis" during vns stimulation. The patient did not wish to have the vns disabled by her treating neurologist. Mfr follow up with the treating neurologist's office revealed the neurologist was aware of the pt's reported vocal cord paralysis, but that the pt had been released from their practice as of (b)(4) 2011 and they had no info. The office did state that the pt was seen on (b)(6) 2011 and the vns was working properly at that time. In addition, the pt refused to have the vns disabled. It is unk which physician the pt may be seeing at present.

Event Description
Reporter indicated that in addition to the vocal cord paralysis, she has also experienced worsening asthma since the vns was implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405348


Title: Re: Voice/Speech
Post by: dennis100 on March 04, 2017, 01:55:37 AM
Model Number 300-20
Event Date 03/26/2013
Event Type Malfunction
Event Description
On (b)(6) 2014, it was reported that the patient was referred for surgery. Device settings and diagnostic results from (b)(6) 2013 were provided. Surgery is likely but has not taken place.

Event Description
The surgeon explanted the patient¿s generator on (b)(6) 2014. The generator was not replaced. After explant surgery, the patient was having nocturnal seizures.

Event Description
It was reported that the patient underwent surgery on (b)(6) 2014. During the surgery the surgeon identified a lead break when the generator pocket was opened. The surgeon replaced the generator; however, the lead was left in place as no consent to replace the lead was obtained prior to surgery. Lead replacement is planned for a later time. The surgeon believes that the lead break was likely caused by excess lead being placed under the generator causing friction. No surgical intervention has been performed to date.

Manufacturer Narrative
Describe event or problem, corrected data: additional information indicates that the generator was not explanted.

Event Description
An implant card reported that the patient had generator reimplant and lead replacement on (b)(6) 2014 due to lead discontinuity. Good faith attempts for product return were performed. The explanted suspect device has not been received by the manufacturer to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, a physician reported that a system diagnostic in (b)(6) 2012 showed high impedance. The patient was sent for x-rays, but x-rays reportedly showed no lead fracture. Therapy was continued at 2. 5 ma 21 seconds on, 0. 8 minutes off. The high impedance message was seen again on (b)(6) 2013 (output status: limit, dcdc=7). The physician felt that the patient was still receiving stimulation because he could hear her voice change. The patient reported that the physician told her that there is something wrong with her wires and that he does not plan to do anything and that he is just going to increase her medications. The patient reported that she is experiencing an increase in seizures and she is bedbound for fear of falling. The physician confirmed that the last normal diagnostics test was on (b)(6) 2012 and that the first high impedance was observed on (b)(6) 2013. The patient's device was never programmed off following the high impedance and is currently still delivering therapy. There was no patient manipulation or trauma. The physician reported that the relation of the seizures to baseline is difficult to determine because the patient's seizures are cyclic. It could not be established whether the seizures were related to vns or other factors.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3568934


Title: Re: Voice/Speech
Post by: dennis100 on March 04, 2017, 01:56:25 AM
Model Number 103
Event Date 12/22/2010
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013, indicate that the patient's mother feels the patient's vns is still working with the periodic voice change and cessation of seizures when swiping the generator with the magnet. The notes state that the patient had generalized convulsive epilepsy, with date of onset (b)(6) 2010. Follow up with the physician's assistant found that the note about the onset of the generalized convulsive epilepsy was carried over from previous notes and they had no additional information to provide.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3569985


Title: Re: Voice/Speech
Post by: dennis100 on March 04, 2017, 01:57:25 AM
Model Number 102
Event Date 09/28/2013
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2013, indicate the patient was only taking once a day dosing of keppra and zonegran in half the doses that the physician had recommended. Per the notes, the patient preferred to continue to take his anti-epileptic medications at those doses because he had been seizure free. On the date of the notes ((b)(6) 2013), the patient returned to the clinic accompanied by his mother reporting that he had a generalized seizure on saturday. His mother states that this was his "biggest seizure ever," it appeared it was a generalized tonic-clonic seizure with tongue bite, his mother reports that it lasted approximately 20 minutes. The patient's current medication regimen is lamictal xr 400 mg in the morning, keppra xr 1500 mg a. M. , and zonegran 200 mg a. M, there are no triggers, the patient is able to identify, he was taken to the emergency room at and no underlying infection was found, he received a dose of valium there and has been recovering at home since, he states that his headache has resolved at this point. Additionally, the patient questioned whether or not his vns was working. He stated that over the past few weeks or so he had noted that his voice has not been changing when the vns is activated. The patient is unable to really feel the stimulation any longer either. Per the notes, the physician interrogated the vns and ran a diagnostic test on the device. Everything appears to be in working order and there are no problems. End of service states no. The physician discussed with the patient could be experiencing a reduction of the battery, or could be getting used to the stimulation. The physician increased the vns settings twice and the patient was able to feel it ("had minimal feeling"). Attempts are being made for additional information; however, no other information has been provided.

Event Description
Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
An implant card was received on (b)(6) 2014 stating that the vns patient underwent generator and lead replacement surgery due to battery depletion and failure to interrogate on (b)(6) 2014. The reason for lead replacement was not provided. Additional information was received stating that the patient was doing ok and that the change in his seizure pattern was due to his confusion with his medication dosage. Additionally, the patient was not feeling stimulation because the he was getting used to output current. The patient¿s replacement device was programmed on during an office visit on (b)(6) 2014. Further follow-up revealed that the lead was replaced because the patient was not receiving the needed therapy based on diagnostic results. It was determined that the device¿s diagnostic results were misinterpreted and the device was not at end of service. The explanted generator and lead were returned to the manufacturer for analysis. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation cannot be performed on that portion of the lead. Analysis of the returned generator is currently underway.

Manufacturer Narrative
The initial manufacturer report inadvertently did not include the outcomes attributed to the adverse event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3570852


Title: Re: Voice/Speech
Post by: dennis100 on March 04, 2017, 01:58:03 AM
Model Number 102R
Event Date 06/01/2012
Event Type Malfunction
Event Description
On (b)(6) 2014, it was reported that this vns patient experienced an increase in seizure frequency during (b)(6) 2012 for an unknown reason. The physician reported that the patient's seizures were cyclic in nature and increased despite vns therapy and without any triggering factor. The seizures resolved to a normal baseline; however, no other information regarding interventions or device functionality at the time was available. It was also reported that the patient experienced pain in the left neck at the electrode site that was reported to the physician on (b)(6) 2012. The pain was occurring with stimulation on times and corresponding with voice alterations. The physician told the patient to tape the magnet over the device; however, this did not cause the pain to stop. X-rays were taken at the patient's appointment on (b)(6) 2012; however, there was nothing remarkable, per the x-ray report. The pain spontaneously resolved at an unknown date. Based on the information available, the physician did not believe the event was related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3575810


Title: Re: Voice/Speech
Post by: dennis100 on March 05, 2017, 01:26:14 PM
Model Number 102
Event Date 09/05/2007
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, unable to assess pin insertion issue. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated the pt presented with high impedance on a system diagnostic test and ok lead impedance on normal mode diagnostic test. The physician reviewed the x-rays, but "did not see anything wrong with the lead or the generator. " the pt feels stimulation and they can hear his voice change with stimulation. X-rays were sent to the mfr for review, but the angle of the x-ray made it impossible to assess if the connector pin was fully inserted. No lead discontinuities were visualized. The pt underwent revision surgery and the physician found the lead pin had become slightly dislodged from the generator boot. The pin was reinserted and diagnostics tests were performed, which yielded ok lead impedance. The pt is reportedly doing better since the revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=950452


Title: Re: Voice/Speech
Post by: dennis100 on March 08, 2017, 04:24:30 AM
Model Number 250
Event Date 04/16/2008
Event Type Malfunction
Event Description
It was initially reported during a review of the pt's programming history that the pt's settings were inadvertently changed at the appointment. All settings were corrected at the time of the reset, except for pulsewidth, which was not corrected until the next appointment on (b)(6)2008. The pt may have experienced some voice alteration, due to the increased pulsewidth, but did eventually resolve after the setting was corrected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1660755


Title: Re: Voice/Speech
Post by: dennis100 on March 09, 2017, 01:58:01 AM
Model Number 201
Event Date 09/28/2009
Event Type Malfunction
Event Description
Initial reporter indicated that their programming wand would not interrogate a pt's vns. They were still able to feel their stimulation and had voice change with stimulation. The physician used the same programming wand on another pt and it interrogated successfully the first time and the second time it did not work. The wand battery was changed, but did not resolve the event. The product is at the mfr pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1518371


Title: Re: Voice/Speech
Post by: dennis100 on March 10, 2017, 04:53:02 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 12/22/2016
Event Type Injury
Event Description
It was reported by a patient¿s provider that the patient had recently fell and was having some discomfort so he went to the er. Device settings were checked and found to the same. Since the fall, the generator had migrated significantly downward. A call was received from the patient¿s caregiver also reporting that the generator had migrated to the sternum. He reported that the lead is now visible through the skin. He stated that his son has always had voice alteration with the device, but it now seems worse. He has since seen a surgeon about performing a revision surgery. It was also stated he was going to have his vocal cords checked to evaluate for any potential damage that may have occurred with the shifting of the generator and lead. Clinic notes were received from a visit to the surgeon on (b)(6) 2017 for replacement referral. The notes provide that the patient was seen at the ed for pain surrounding his vns battery. X-rays were done and labs did not reveal any sign of infection, so he was discharged home. He returned again to the ed. He did not feel his vns activate for several hours. His vns was found to be working appropriately. The battery was in an uncomfortable position for him, and was at the very superior aspect of the sternum. The skin overlying the battery and nearby lead is thin. He feels significant discomfort when lying down or on his side. He is concerned that the battery moves, but it was reported the battery has always been in this approximate position. He said it may have even been a little higher in the neck right after surgery. He has hoarseness to his voice constantly, and the patient denies any hoarseness prior to surgery. The battery is slightly mobile, but not more than expected. The skin overlying this area is thin but intact. Palpation and manipulation of the battery causes some pain. X-rays reviewed showed the vns generator overlying the superior aspect of the sternum. The lead is in an expected location. There is no evidence of fracture. It was provided the vns is in an unusual position. It was stated that the vns is functioning properly in the current location, but that it is not in the most common site for generator placement and is causing the pain. It was stated they are concerned the patient may have vocal cord paralysis from injury to the recurrent laryngeal nerve. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309855


Title: Re: Voice/Speech
Post by: dennis100 on March 10, 2017, 04:53:53 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient's lead and generator were explanted due to voice changes and because the patient wanted the device removed. The operative notes regarding the explant were received but did not report any anomalies or allegations against vns. No further relevant information has been received to date. No product has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6330691


Title: Re: Voice/Speech
Post by: dennis100 on March 10, 2017, 04:54:57 AM
Model Number 302-30
Device Problem Fracture
Event Date 02/03/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported by the physician that upon interrogation of the patient's generator, a warning message stated that high impedance had been detected. The patient had reported several falls in the previous two weeks. The patient's wife noted that the patient had been experiencing some vocal hoarseness. The generator settings were lowered and the magnet mode was disabled. The lowered settings did not resolve the vocal hoarseness. No surgical intervention are known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6364696


Title: Re: Voice/Speech
Post by: dennis100 on March 11, 2017, 03:24:16 AM
Model Number 302-20
Device Problem High impedance
Event Date 09/01/2009
Event Type Malfunction
Event Description
It was reported to manufacturer that the vns patient's device revealed high lead impedance on both systems and normal mode diagnostic tests that were (b) (6) 2009, which revealed normal device function. There was no patient trauma or manipulation reported to have occurred between (b) (6) and (b) (6) 2009. Clinical notes were received which documented the patient's clinical presentation on the date that the diagnostic test revealed high lead impedance. The physician noted that the patient "has been averaging 3. 6 seizures per month over the past three months. This actually is double and almost triple his seizure frequency over the past nine months. " the physician also noted that the patient "will occasionally get some pain as he has in the past but usually he does not. He usually just notices hoarseness in his voice and perhaps a little tingling in his neck. " the device was programmed off on (b) (6) 2009. Good faith attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date. Revision surgery is likely.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1511693


Title: Re: Voice/Speech
Post by: dennis100 on March 11, 2017, 03:25:13 AM
Model Number 302-20
Device Problem High impedance
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was initially reported that the high impedance was observed during a diagnostic test performed. The patient's mother has since reported an increase in his seizure level, which is still below pre-vns baseline levels, but this is believed to be due to medication changes by the surgeon. The patient is said to not have the same change in voice as he used to, which also began about the same time as the increase in seizure level. The surgeon believes that this is due to the patient becoming accustomed to the therapy. It was noted that during the patient's change in valium, there was an increase in seizures earlier in the year. There was then another increase in seizures reported during the summer time, which was not during a known medication change with no noted cause by the surgeon. The patient has also said to have received efficacy from the therapy as his trips to the er have been reduced from 18 per year pre-vns to 2 per year. There was no known trauma or manipulation that could have contributed to the high impedance or increase in seizures. Battery life calculation performed using programming history in the manufacturer's programming history database resulted in approximately 7. 36 years until eri=yes. Last known diagnostics were performed on (b) (6) 2009, which were within normal limits. X-rays were taken, but were not provided to the manufacture for review. Revision surgery is expected to occur.

Manufacturer Narrative
Device malfunction is suspected, but did not contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1511695


Title: Re: Voice/Speech
Post by: dennis100 on March 12, 2017, 01:21:29 AM
Model Number 304-20
Event Date 11/07/2012
Event Type Injury
Manufacturer Narrative

Event Description
Good faith attempts were made and no further information was attained.

Event Description
Additional information was received that the patient is seizure free and his voice is back to. As noted at his follow up office visit the week of (b)(6) 2013.

Event Description
A vns patient called to report that since their implant (b)(6) 2012, they were having issues. It was reported that since he had his vns placed, he has had shortness of breath and voice alteration that won't go away. The patient also reported that he had one of the worst seizures last night that he has ever had. The patient's vns was not programmed on. The patient reported that their neurology office would not program his vns on till his shortness of breath and voice alteration resolve. The estimated time of surgery was 45 minutes. There were no complications reported during the procedure. Final interrogation showed device was at 0. 0 output current, and 0. 0 magnet current. The patient was seen by an ent physician and it was noted that his left vocal cord was "weak" due to vocal cord paralysis. The patient reported that the ent and implanting surgeon said his device could be turned. The patient also no longer reports shortness of breath, but still has hoarseness. The patient is scheduled to have a procedure with the ent to adjust his vocal cords closer together using a scope. Further followup will be performed to attain more details about the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870353


Title: Re: Voice/Speech
Post by: dennis100 on April 18, 2017, 10:32:43 PM
Model Number 102
Event Date 09/16/2011
Event Type  Injury   
Event Description
Additional information was received indicating that surgery to replace the patient's generator has occurred. The explanted generator has been returned and undergone analysis. The generator performed to specifications and no anomalies were found.

Event Description
It was reported via clinic notes received dated (b)(6) 2011 that the patient was experiencing more frequent breakthrough seizures after being seizure free for almost 3 years. The physician indicated that the vns battery may be nearing end of service; however, diagnostics were normal and did not indicate the generator was near end of service. The notes state that the patient is still experiencing intermittent hoarseness with stimulation indicating the patient is still feeling stimulation. After 1 seizure that resulted in a fall, it was noted that the left side of the patient's chest appeared more swollen and the patient's wife expressed concern that the generator may have shifted position. The physician stated that there was a possibility that the reduction of the pulse width from a previous visit may be a contributing factor. Attempts for further information have been unsuccessful to date. Surgery to replace the patient's generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2308207


Title: Re: Voice/Speech
Post by: dennis100 on April 18, 2017, 10:33:26 PM
Model Number 303-20
Device Problem No Known Device Problem
Event Date 12/19/2016
Event Type Injury
Manufacturer Narrative

Event Description
Information was received indicating that the patient's voice was "extremely" hoarse. The hoarseness was not cyclical but constant. The patient was referred to an ent for injects. The hoarseness was present after the patient's implantation surgery in (b)(6) 2016 where the patient's generator was programed on. The patient's generator was disabled in february to allow the patient to heal. Diagnostics of the patient's device were within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6378738


Title: Re: Voice/Speech
Post by: dennis100 on April 18, 2017, 10:34:19 PM
Model Number 302-20
Device Problem Fracture
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a lead revision due to a suspected lead break. It was also reported that the patient experienced minimal discomfort and intermittent vocal hoarseness. Further follow-up found that the patient had been doing yard work and felt discomfort in his upper left chest. The normal mode of the device was programmed off and the magnet mode left programmed on. The physician later performed diagnostic testing which indicated that there was high impedance in the system. The patient was referred to surgery where the generator was first replaced and the existing lead was inserted into the new generator. However high impedance did not resolve which indicated an issue with the lead. The lead was then replaced and the new lead and new generator functioned within acceptable limits. The explanted lead and generator have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6401320


Title: Re: Voice/Speech
Post by: dennis100 on April 20, 2017, 12:56:20 AM
Model Number 102
Event Date 01/01/2008
Event Type Malfunction
Event Description
Reporter indicated that the pt experienced worsening depression following parameter decrease due to voice alteration and dysphagia. Further follow up with the physician revealed that it is unk whether the worsening depression is above, below, or back to pre-vns baseline.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022718


Title: Re: Voice/Speech
Post by: dennis100 on April 20, 2017, 05:45:23 AM
Model Number 302-20
Event Date 11/12/2007
Event Type Injury
Event Description
Initial reporter indicated that postoperatively the pt developed hoarseness and numbness near their neck incision. It was additionally reported that the pt was evaluated by an ent surgeon and was diagnosed with left vocal cord paralysis. No interventions have been planned to treat the left vocal cord paralysis. The pt's vns has not been programmed on and they have not had any seizures since their revision surgery. The treating physician is attributing the vocal cord paralysis to the revision surgery. There are no plans to program the vns therapy on at this time. Mdr report number: 1644487-2007-01964 can be referenced for the revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979772


Title: Re: Voice/Speech
Post by: dennis100 on April 20, 2017, 05:46:14 AM
Model Number 102
Event Date 01/04/2008
Event Type Malfunction
Event Description
The reporter indicated that the pt left the operating room, with his vns device inadvertently turned on to 1ma. The pt has experienced hoarseness and extreme pain since the day of surgery. In 2008, the pt requested reprogramming of their generator to 0. 25ma. Good faith attempts for additional info are in progress and awaiting response.

Manufacturer Narrative
Device malfunction is suspected, but did not contribute or cause a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=997958


Title: Re: Voice/Speech
Post by: dennis100 on April 20, 2017, 05:47:09 AM
Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, and a section of the lead appeared to be tightly coiled and twisted. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that a vns patient "could not feel her device working". It was reported that the patient had previously experienced voice alteration with stimulation, but that this event was no longer occurring. Normal mode and system diagnostic tests were then performed, and these tests indicated high lead impedance. The physician reported that previous diagnostic tests had been within normal limits. X-rays were reviewed by the mfr and it was identified that a large section of the lead was tightly coiled and twisted. Revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=981047


Title: Re: Voice/Speech
Post by: dennis100 on April 21, 2017, 03:27:22 AM
Event Date 10/29/2007
Event Type Injury
Event Description
Initial reporter indicated, the patient has had continuous hoarseness since two days after implant. The event was reported to be related to the vns implant procedure. The patient has now been diagnosed with left vocal cord paralysis. No interventions are planned. The patient continues vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=963315


Title: Re: Voice/Speech
Post by: dennis100 on April 21, 2017, 03:28:02 AM
Model Number 102
Event Date 11/01/2007
Event Type Injury
Event Description
It was reported to manufacturer that the magnet is not working as effectively as it had in the past, and that the magnet mode stimulation is not perceived when swiped. The physician performed systems diagnostic, normal mode, and magnet mode diagnostic tests and all results indicated normal device function. The physician stated, that the patients' voice was "warbly sounding with stimulation". The physician increased the magnet output current to 2. 0ma, and when the magnet was swiped, the patient had a strong reaction. The magnet was then swiped again and the patient did not react as strongly. Additionally, the physician stated that at this office visit, the magnet was swiped a total of four times, and when they looked at the magnet history, it only showed two additional magnet swipes. Attempts to obtain additional information regarding additional troubleshooting from the physician have been made, but have been unsuccessful to date. The physician has opted to refer the patient for a generator replacement due to the magnet not working properly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=960032


Title: Re: Voice/Speech
Post by: dennis100 on April 21, 2017, 03:30:00 AM
Model Number 102
Event Date 08/01/2007
Event Type Injury
Event Description
It was reported that the vns patient had their device removed due to worsening depression, suicidal ideations, and pain following a mammogram procedure. Additionally, it was reported by the patient that the physician advised that due to a pre-existing back problem, mri's would be necessary to have the device removed. The device was reported to have been disabled in aug 2007 due to intolerable voice alteration and the increase in depression. There is no programming or diagnostic history available in house to review. Attempts to obtain add'l info from the treating physician have been made, but have been unsuccessful to date. Attempts to obtain the explanted product(s) are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=958440


Title: Re: Voice/Speech
Post by: dennis100 on April 21, 2017, 03:30:44 AM
Event Date 11/09/2007
Event Type Injury
Event Description
Reporter indicated that a vns pt has experienced vocal cord paralysis after undergoing lead revision surgery due to high lead impedance, reported on mfr. Report #: 1644487-2007-01933. The pt's voice was reported to have been continually hoarse following the procedure. The pt has not seen an ent and it is unk which vocal cord is affected. The treating neurologist believes the cause of the event to be the lead revision surgery. Stimulation has been initiated. Good faith attempts for add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964271


Title: Re: Voice/Speech
Post by: dennis100 on April 21, 2017, 03:31:34 AM
Model Number 302-20
Event Date 11/20/2007
Event Type Malfunction
Event Description
It was reported to mfr that a sys diagnostic test performed on the vns pts device revealed high lead impedance with output status ok. A second system diagnostic test performed at the same office visit revealed high lead impedance with the out put status at the limit. The pt presented at the physicians office with continuous neck pain and extreme coughing during stimulation of the device, which began the previous day. The pt reported having had pulled his left neck muscle the day prior. Additionally, the physician stated that the pt is a truck driver and does "a lot of movement in his neck, so he may have stretched the leads". It was recommended to set the normal mode and magnet mode output current ot 0ma, however the physician opted to decrease the settings from 1ma to 0. 75ma decrease the pulse width from 500usec to 250usec. The coughing and the pain improved with the setting change. The pt was referred to the implanting surgeon to have the device replaced. Preoperative interrogation of the device revealed that at some point the device output current had been set to 0ma. During surgery, it was observed that the negative coil was a "burnt yellowish color" and that the "nerve was burnt at the site where the negative electrode was in contact with the nerve". The area above and below the burnt area on the nerve was swollen. The entire lead, including the electrodes was removed,and a new lead was implanted. The generator was replaced prophylactically. Additionally, the surgeon reported that the pt was experiencing hoarseness prior to the device being removed. Attempts to obtain the explanted devices for analysis have been made, but have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2998029


Title: Re: Voice/Speech
Post by: dennis100 on April 23, 2017, 02:02:44 AM
Event Date 05/01/2009
Event Type Malfunction
Event Description
It was reported to the manufacturer that vns pt's device showed high lead impedance during diagnostic testing at an office visit. It is unk when the pt's device diagnostic tests were last within normal limits prior to this office visit. It was indicated that the pt was punched in the chest near the generator with a binder. The pt is still able to perceive stimulation and continues to experience voice alteration with stimulation. The pt's device was not programmed off per physicians discretion. It was also indicated that the pt has been experiencing an increase in seizure activity. It is unk if the increase was above pre-vns baseline level. The increase in seizure activity is believed to be a result of loss of therapy from the high lead impedance event. X-rays were taken of the pt's device and sent to the manufacturer for review. A lead fracture was identified in the neck region of the device, distal to the anchor tether, which is believed to have caused the high impedance event. The pt is being scheduled for revision surgery. Good faith attempts to obtain add'l info regarding the reported event 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575842


Title: Re: Voice/Speech
Post by: dennis100 on April 27, 2017, 01:16:12 AM
Model Number 302-20
Event Date 10/01/2007
Event Type Injury
Event Description
Reporter indicated a pt developed an infection at the vns electrode site in the neck and a tie-down was extruding from the neck. The pt's vns was later explanted. Per the reporter, the pt had caused the infection and tie-down extrusion due to picking at the incision site. After the vns explant surgery, the infection did not resolve and the pt needed add'l neck wound surgery. The pt's vocal chords were damaged as a result of the add'l surgery. The pt later received gel injections to the vocal chords from a ent surgeon which has improved, but not resolved, the pt's vocal chord problems. The explanted lead portion and generator were returned for analysis. No anomalies were noted and the device performed per specifications. The electrode array was not returned. Attempts for further info are in progress.

Manufacturer Narrative
Device mfg records were reviewed. Review of mfg 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=1558563


Title: Re: Voice/Speech
Post by: dennis100 on April 28, 2017, 01:25:07 AM
Model Number 300-20
Event Date 10/26/2009
Event Type Malfunction
Event Description
It was reported that system diagnostics resulted in 7/limit/high/no at follow up appointment. The treating nurse indicated the pt had been seen two weeks prior to the event and diagnostics were within normal limits. At the moment, no pt trauma or manipulation has been reported. In addition, the pt still perceives stimulation as she still has the side effect of voice alteration due to stimulation. Further recommendations were given to the nurse to program the pt's device off. Currently, no x-rays are going to be taken as revision surgery is likely.

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=1550873


Title: Re: Voice/Speech
Post by: dennis100 on April 29, 2017, 12:47:21 AM
Model Number 101
Event Date 11/28/2007
Event Type Injury
Event Description
Reporter indicated a vns patient present with "increase seizure frequency and has the clinical perception that the device was not activating as strongly as in the past. The pt's seizure activity level is higher than it was prior to being implanted with the vns therapy system. The "seizures are somewhat more intense in many respects than they have been for a number of years. " the treating physician "felt that there was not much electrical evidence for device failure. " the pt has a history of tracheomalacia and tracheal surgery; therefore, the pt was referred to the ent. The ent indicated that pt's "right vocal cord function is normal. The left vocal cord function at baseline is abnormal and reduced, but with stimulation from the device, there is visible motion of the vocal cord consistent with the electrical input to the vagus nerve from the device. " the physician suspects the vns therapy system may be "nearing end of service life. " 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=1015571


Title: Re: Voice/Speech
Post by: dennis100 on May 01, 2017, 12:33:12 AM
Model Number 103
Event Date 02/01/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device ¿quit¿ and that the patient was experiencing an increase in seizures. The patient no longer felt stimulation from his device. The patient stated that he swiped his magnet but did not feel magnet mode stimulation and did not have any voice alteration like he normally would. The patient denied experiencing any trauma. No known interventions have occurred to date.

Event Description
Additional information was received stating that the vns patient was doing fine and that diagnostic results showed normal device function. The patient¿s seizures were back to pre-vns baseline levels. The physician stated that the patient¿s increase in seizures and failure to perceive stimulation were due to the patient¿s device being disabled. The patient¿s device was programmed back on following these events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4002981


Title: Re: Voice/Speech
Post by: dennis100 on May 01, 2017, 12:35:07 AM
Model Number 103
Event Date 07/23/2014
Event Type Injury
Manufacturer Narrative

Event Description
Patient underwent generator replacement on (b)(6) 2015 due to eos-yes (pulse disabled). The m103 generator was returned for analysis on 03/04/2015. Analysis is underway but has not been completed to date.

Event Description
Product analysis for the generator was completed and approved on 04/01/2015. The pulse generator would not interrogate during the decontamination process or in the product analysis lab. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 351 volts, indicating an eos condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Further follow-up revealed that both the pain at the generator site and voice alteration only occur when the device is pushed on. Spoke to the nurse at dr (b)(6) office who confirmed that the patient was experiencing pain at the generator site and voice alteration only when the device was being pushed on. Clinic notes dated (b)(6) 2014 note that the patient states that he has had some events over the past month where he would lose consciousness. It was reported that the episodes of syncope were not related to the vns device and were due to the non-epileptic seizure disorder that the patient is diagnosed with.

Event Description
Clinic notes were received indicating that the vns patient was experiencing pain whenever pressure was applied to the device. The patient was determined to be not epileptic. Interrogation showed that the device was at end of service and disabled. The patient stated that he had not felt vns stimulation for years and felt like his voice was different. The patient was referred for surgery but no known surgical interventions have occurred to date.

Manufacturer Narrative
Corrected data: this information was inadvertently left off of initial mdr: "clinic notes dated (b)(6) 2014 note that the patient states that he has had some events over the past month where he would lose consciousness. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4031390


Title: Re: Voice/Speech
Post by: dennis100 on May 02, 2017, 01:43:58 AM
Model Number 102
Event Date 05/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has not been returned to date. A battery life calculation using the available programming history showed approximately 3. 2 years until eri = yes on (b)(6) 2014.

Event Description
It was reported that the vns patient was admitted to the hospital on (b)(6) 2014 because the patient was unable to perceive stimulation and believed his device was not working. The patient¿s device was disabled while the patient was in the hospital. At discharge, the neurologist programmed the patient¿s device back on to its original settings; however, the patient was unable to tolerate stimulation so the device settings were decrease. Clinic notes were received indicating that the vns patient was admitted to the hospital on (b)(6) 2014. Since the patient¿s last hospitalization on (b)(6) 2014, the patient was experiencing an increase in seizures and had 20 seizures in the past two weeks prior to hospitalization. The patient¿s device settings were increased upon admission and again on (b)(6) 2014. The patient subsequently complained of chest pressure, coughing and voice changes, but the symptoms resolved and the patient was able to tolerate the new device settings. The patient¿s new settings were still lower than his baseline device settings. The patient stated that his device was not working properly; however, the notes indicate that the patient¿s voice changes and coughing showed that the patient¿s device was providing stimulation. Furthermore, the patient¿s device was tested and system diagnostics showed normal device function at the time. Continuous video-eeg monitoring showed that the patient was not in status. The patient¿s medications were adjusted for better seizure control; however, the patient subsequently had a cluster of seizures on (b)(6) 2014 after the medication adjustments. The patient¿s medications were re-adjusted and the patient did not have any more seizures while hospitalized. The patient was discharged on (b)(6) 2014. The patient was referred for surgery but no known surgical interventions have occurred to date. Follow-up revealed that the patient¿s increase in seizures began in (b)(6) 2014. The neurologist attributes the voice changes to stimulation and stated that the increase in seizures may have been related to the patient¿s medications. The patient has since had better seizure control with medication adjustments but continues to have painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3980999


Title: Re: Voice/Speech
Post by: dennis100 on May 02, 2017, 10:52:54 PM
Model Number 302-20
Event Date 10/29/2014
Event Type Injury
Event Description
On 12/01/2014, it was reported that the patient had an injury at his lead site at the collarbone and a subsequent infection. The patient was working on his home and left his caulking removal tool at the top of the ladder and when he climbed back up the ladder his tool fell and struck him in the chest. The patient made an appointment with his physician, and during his appointment on (b)(6) 2014, the patient was put on antibiotics. He returned for follow-up one week later and was told it was getting moderately better. A week after that appointment ((b)(6) 2014), he was told it was improving but he was not doing as well as expected. The physician stated the infection had attached itself to the lead wires. On a 3rd visit a week later ((b)(6) 2014), the general chest infection had cleared up but remained on the lead wire. The patient was then referred to an infectious diseases doctor who recommended that the vns therapy system be removed. It was also reported that the patient¿s leads were fractured and the ¿wire is sticking out of the skin¿. The patient declined to be re-implanted as he had not had efficacy with vns. He stated that he knows the vns is no longer working because he no longer feels hoarseness in his throat or voice alteration and there was usually a ¿tickle on the vocal cord¿ during stimulation. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334606


Title: Re: Voice/Speech
Post by: dennis100 on May 02, 2017, 10:54:19 PM
Model Number 304-20
Event Date 10/01/2014
Event Type Injury
Event Description
It was reported that the patient noticed hoarseness over the past 6 weeks. A ct scan showed no lesions or masses. The patient was seen by an ent who diagnosed the patient with left vocal cord paralysis. The ent suggested that the vns be explanted pending the vocal cord paralysis. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
Further follow-up revealed that the cause of the vocal cord paralysis is unknown. The physician reported that it is unknown if the patient has a history of vocal cord paralysis prior to vns implantation. The ent plans to monitor the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334706


Title: Re: Voice/Speech
Post by: dennis100 on May 02, 2017, 10:56:18 PM
Event Date 11/18/2014
Event Type Injury
Event Description
It was reported that the low device settings were not tolerated by the patient. Vns removal is under consideration but has not been performed to date. The patient did not allow lower settings to be used and the device was programmed off.

Event Description
It was reported that the device was programmed on to 0. 25ma. The patient complained of pain, hoarseness, and chest pain that lasted through the weekend. The device was programmed off again on (b)(6) 2015.

Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized for vocal cord paralysis after initial vns implant. A scope was performed and confirmed vocal cord paralysis. The device has not yet been programmed on. The physician reported that the patient would be seen by and ent and that the device will not be programmed on yet. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported that the vns was programmed on at low settings and the patient is tolerating them at this time.

Event Description
It was reported that the patient铠voice issues have improved. The device was programmed back on to low settings.

Event Description
It was reported that an ent performed a scope and diagnosed the patient with vocal cord paresis. The patient refused steroid treatment and was discharged home. It was reported that the patient's voice has improved dramatically. The patient underwent a swallow evaluation that was normal and another ent scope identified that the patient was much improved and the vocal cord was working.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334503


Title: Re: Voice/Speech
Post by: dennis100 on May 02, 2017, 10:59:59 PM
Model Number 102
Event Date 05/01/2014
Event Type Injury
Event Description
Clinic notes were received for the vns patient¿s office visit with her neurologist on (b)(6) 2014. The patient had a seizure cluster the day of the office visit and was experiencing an increase in seizures. The patient had four seizure clusters in the past month before the office visit. The notes indicate that there were some issues with the patient¿s device as the patient was no longer having vocal changes or coughing when she swiped her magnet. The patient¿s device was tested during the office visit and system diagnostics showed normal device function at the time. The patient was given new medication and was referred for surgery. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The physician confirmed that the patient is undergoing routine generator replacement and the reported increase in seizures had not relationship to the vns system. The patient underwent generator replacement. The generator has not been received for analysis to date. An implant card was received indicating that the patient underwent generator replacement due to battery depletion neos = yes.

Event Description
It was reported that the explanted device will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3977799


Title: Re: Voice/Speech
Post by: dennis100 on May 03, 2017, 12:56:54 AM
Device Problem Migration of device or device component
Event Date 11/01/2013
Event Type Injury
Event Description
It was reported that the patient¿s left side of the neck is swollen from behind her left ear to down her neck, and that when she leans on her left side, she feels the battery sliding down underneath her axilla. It was reported that this has been going on for a year on and off and the welling would come and go. The patient reported that it started just prior to her cabg last year, but has worsened since that surgery. She said for the last week, it has remained swollen and she is coughing a bit of blood from her throat. The patient now wants the device removed. The patient saw a cardiologist and she doesn¿t have jvd, but the cardiologist stated that possible the lead was eroding the vocal cord area. The patient stated that she has had an mi and cva this past (b)(6) 2014. Per the patient¿s primary care physician, she does not need to see an ear, nose, and throat physician. However, the patient is still having neck swelling on the left side of her neck. Although surgery is likely, it has not occurred to date.

Event Description
Information was received from two of the patient's physicians. The first physician indicated the last device check was on (b)(6) 2015 showing normal battery status, normal lead impedance and no vns parameters were altered. The physician indicated that the patient has not reported any of the prior symptoms to him. The second physician indicated the last device check was (b)(6) 2015 and the device battery was indicated to be at end of service, lead impedance was ok and no parameters were changed. He indicated that that patient had reported dysphagia and throat pain but none of the other prior symptoms. No specific interventions were undertaken. Clinic notes were subsequently received for the (b)(6) 2015 office visit which indicated that the device would be replaced due to end of service. The notes indicated that the vns give her trouble with breathing but no specific intervention is referenced. The patient subsequently called the manufacturer and reported that her seizures were worse than before vns. The patient underwent pulse generator replacement on (b)(6) 2015 however high lead impedance was detected when the indwelling lead was connected with the new pulse generator despite repeated removals and insertions. The surgeon elected not to replace the lead during the surgery. Post-implant lead impedance also measured high. Lead impedance with the prior pulse generator was normal. Review of prior programming and diagnostic data reveals fluctuating lead impedance suggesting an intermittent short circuit condition. A battery life calculation using the available programming history showed approximately 0. 2 remaining until neos = yes. No known additional surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
It was later reported that the patient has ¿burn marks¿ over her lead. Good faith attempts for further information from the physician have been unsuccessful.

Event Description
The patient indicated that she feels her lead has moved, is wrapped around her esophagus, is choking her and causing throat pain. She stated that she has continuous voice alteration but no longer feels device stimulation since the time of her last interrogation 2 months prior. She stated she has coughs up blood and has a tight feeling in her chest. She stated that her generator is under her armpit. She indicated her neurologist will be speaking with her other providers, including her cardiologist, for clearance to replace her generator and lead. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

Event Description
On (b)(6) 2015 the patient reported that he is having serious problems with the vns. The patient later reported that she is still having neck pain and swelling in the left side of the neck, feeling vibration and pulsing. She also stated that when she places the magnet over the device, she feels that stimulation is stronger. She also coughed up some blood.

Event Description
Operative notes containing a record of the pulse generator replacement on (b)(6) 2015, during which high impedance was observed following connection of the new generator to the indwelling lead, were received. The operative notes state that it was suspected that the high impedance measurement may possibly be due to emi from surrounding medical devices and was therefore left in place for interrogation in the postanesthesia care unit.

Event Description
Information was received indicating that the patient was scheduled for lead revision surgery. The patient subsequently reported that she was hospitalized due to multiple seizures and stated she was experiencing unusual seizures. The patient underwent surgery for the high impedance condition as reported and described in mfr. Report # 1644487-2016-00375.

Event Description
A provider reported that the patient called her to schedule an appointment to check on her vns which since (b)(6) (2015) is causing burn marks. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334258


Title: Re: Voice/Speech
Post by: dennis100 on May 04, 2017, 12:50:50 AM
Model Number 302-20
Event Date 06/12/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s parent stated that she no longer heard the patient¿s voice alteration that normally occurred with stimulation. The patient went to the hospital on (b)(6) 2014 after having three generalized seizures the previous week. It was noted that a football hit the patient in the chest/clavicle the previous week. The physician stated that the reported event was related to vns stimulation. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Further follow-up revealed that the patient¿s device was disabled on (b)(6) 2014. The patient¿s seizures had changed in type and were longer. Prior to the event, the patient only had simple seizures. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. The patient was doing well following lead replacement surgery.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery due to lead discontinuity. The explanted lead was returned to the manufacturer for analysis. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the lead may have contributed to the reported high impedance. During the visual analysis, quadfilar coil 1 appeared to be broken approximately 24mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break and identified the area on two of the broken strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The area on a third broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Scanning electron microscopy was performed on the electrode (mating end) of quadfilar coil 2 coil break (found at 24mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the coil surface. 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. The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 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 and no other discontinuities were identified. Note that since the (+) white electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3918410


Title: Re: Voice/Speech
Post by: dennis100 on May 04, 2017, 12:51:29 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description
Clinic notes were received indicating that the vns patient was experiencing an increase in seizures in (b)(6) 2013. The patient¿s device settings were increased during an office visit on (b)(6) 2013 and the patient subsequently developed throat pain and voice hoarseness. The patient¿s device settings were adjusted on (b)(6) 2013. The patient did not have any seizures but continued to have painful stimulation. On (b)(6) 2013, the patient¿s device settings were increased and the patient reported no pain but persistent voice hoarseness. Follow-up revealed that diagnostic results at the time showed normal device function. The patient¿s seizures were above pre-vns baseline levels, but not all of the patient¿s seizures types increased. No changes occurred to the patient¿s medications or device settings which may have caused or contributed to the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3941357


Title: Re: Voice/Speech
Post by: dennis100 on May 04, 2017, 12:52:51 AM
Model Number MODEL 250
Event Date 06/27/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the vns patient was having intolerable voice issues on an hourly basis. The patient¿s device was interrogated and found to be programmed to settings indicative of an interrupted system diagnostic test. The patient¿s device was tested during an office visit the previous day, but the system diagnostic test had to be interrupted because the test was too painful for the patient to tolerate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3952700


Title: Re: Voice/Speech
Post by: dennis100 on May 04, 2017, 12:53:41 AM
Model Number 103
Event Date 07/01/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s response to the removal of the magnet was a vasovagal response. The patient experienced confusion and a seizure following the removal of the magnet. No changes to medication or device settings were made prior to the event, which was clarified to be not an increase in seizures. The patient's anxiety was reported to be related to vns stimulation. The patient experienced both anxiety and a vasovagal response previously with vns stimulation.

Manufacturer Narrative

Event Description
It was reported that the vns patient had taped her magnet over her generator to disable her device due to voice alteration. When she removed the magnet, the patient began to feel confused and reportedly had a seizure. The patient stated that she was experiencing an increase in seizures when her device was programmed back on. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3958493


Title: Re: Voice/Speech
Post by: dennis100 on May 04, 2017, 12:55:33 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 05/30/2014
Event Type Injury
Event Description
It was reported that the recently re-implanted vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead due to infection. The patient was re-implanted on (b)(6) 2014 but again underwent explant surgery on (b)(6) 2014 due to infection. The patient was given iv antibiotics. The patient is expected to be re-implanted once the infection is cleared. The patient has not been re-implanted to date. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient's voice is good after receiving injections from an ent; therefore, the patient will undergo vns reimplant.

Event Description
Additional information was received that the patient was implanted with a new vns system on (b)(6) 2015.

Event Description
Additional information was received stating that the vns patient was taken off antibiotics and had his picc line removed. The patient was given new medications and was reported to be doing well so the patient has not been re-implanted to date. The infection was first noted during an office visit on (b)(6) 2014.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient will not undergo vns reimplant because the patient has severe vocal cord damage. The vocal cord damage was reported in mfr. Report # 1644487-2014-02354.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3947614


Title: Re: Voice/Speech
Post by: dennis100 on May 05, 2017, 02:37:38 AM
Model Number 103
Event Date 05/09/2014
Event Type Injury
Event Description
It was reported that the recently re-implanted vns patient had intractable hiccups following replacement surgery on (b)(6) 2014. The surgeon had never performed lead replacement prior to the procedure. The patient¿s device was disabled on (b)(6) 2014 to determine the relationship of the hiccups to vns. Despite disablement, the patient¿s hiccups continued. The patient was admitted to the hospital on (b)(6) 2014 due to ¿mini¿ status epilepticus. The surgeon attributed the seizure to device disablement. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was unable to tolerate stimulation so his device was programmed off on (b)(6) 2014. The patient¿s medications were subsequently increased. The patient¿s hiccups resolved, but the patient began have small seizures every five minutes and went to the er on (b)(6) 2014. Clinic notes were received indicating that the patient was off his medications while he was at the implant facility, which the neurologist stated likely contributed to the increased seizures. The patient¿s device was programmed back on during an office visit on (b)(6) 2014. Despite low device settings, the patient was unable to tolerate stimulation. The patient turned red, began coughing forcefully, and was gagging as if he were about to vomit so his device was programmed back off. Clinic notes dated (b)(6) 2014 indicate that the patient¿s device had been programmed back on and that the patient did not have any hiccups for the past 15 days. The patient was experiencing worsening voice hoarseness and difficulty speaking since replacement surgery. The patient had frequent auras which magnet mode stimulation has helped reduce. The notes indicate that the botched replacement surgery caused the patient to develop vocal cord paralysis. The patient was referred to an ent for evaluation. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3889457


Title: Re: Voice/Speech
Post by: dennis100 on May 06, 2017, 02:39:22 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 01/22/2014
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Patient had her device disabled 2 years ago due to pain from scarring that the previous lead had left behind on the nerve. After the lead revision in 2014, patient's nerve had been damaged enough to where the pain and voice alteration had become so unbearable that the device had to be disabled. The neurologist referred the patient explant surgery as he did not feel that the patient needed the vns therapy any more as she has been seizure free for a year and a half now despite device disablement. Patient underwent explant surgery and both the generator and lead including the electrode coils were completely removed without issues. Pre-op system diagnostics was performed and all results were ok. The patient had reported about pain in the jaw and neck area prior to surgery. Prior to surgery, an ent physician mentioned that the patient's left vocal was little weak. The physician was not sure if the weakness was from previous surgery or if its recent. It was not suspected to be vns related necessarily. It was also mentioned that the surgery is not to preclude a serious injury and that the physician recommended explant as patient did not need it anymore. Patient's seizures were well controlled with medications. The surgeon stated that he did not see any obvious nerve damage. However, he thought that patient's left recurrent laryngeal nerve was injured on the previous vns revision in 2014. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6495445


Title: Re: Voice/Speech
Post by: dennis100 on May 07, 2017, 01:28:41 AM
Model Number 304-20
Event Date 02/26/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for vocal cord surgery. The patient was diagnosed by the ent with dysphonia. The patient did not have any vocal cord issues prior to vns. The patient¿s dysphonia began immediately following vns implant. The patient¿s device was never programmed on. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

Event Description
The patient's ent reported that the patient has left tvc paralysis with moderate to severe dysphonia. The ent reported that the surgery is to medialize the left tvc to improve the patient's voice and is not to preclude a serious injury. The patient is undergoing speech therapy. The ent reported that the dysphonia is expected to improve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3889359


Title: Re: Voice/Speech
Post by: dennis100 on May 08, 2017, 01:25:18 AM
Model Number 300-20
Event Date 04/24/2001
Event Type Injury
Manufacturer Narrative

Event Description
The patient had generator and lead explant surgery on (b)(6) 2014 to undergo other indication treatment. The explanted products were discarded.

Event Description
Clinic notes dated (b)(6) 2014 reported that by the patient¿s report, she had occasions of unilateral vocal cord paralysis following vns procedure. Subsequently, she seemed to stabilized after undergoing a vocal fold injection procedure. The vocal folds were evaluated to be bilaterally mobile with exhibition of mild edema. The patient presented with report of progressively worsening breathing difficulties. The vns generator was programmed off to 0ma which the physician evaluated may provide some immediate relief with respect to the breathing issues. It was previously reported that the patient had vns programming changes made due to tolerability issues including with subtle hoarseness during stimulation but was tolerated. A note from (b)(6) 2007 indicated the patient had increasing breathing problems and was unknown if related to a recent increase in settings. Later in (b)(6) 2008, the patient felt the breathing issues were related to vns and as a result did not want to increased settings. In (b)(6) 2008, the treating physician indicated the patient¿s asthma was worse and unknown if related to vns at that time. The patient's previously treating physician who managed the vns treatment has retired.

Event Description
Operative notes from explant surgery on (b)(6) 2014 were received and indicated that the pre- and post-operative diagnoses was dyspnea and chronic laryngitis. The indication for procedure detailed that the patient developed chronic laryngitis with symptoms of constriction of the larynx after vns implant, which may be related to the vagal nerve stimulator lead. The surgeon noted that they had concerns that the vagal nerve stimulator may be ¿inappropriately activating the recurrent laryngeal nerve. Because of this, the device will need to be removed. " the generator (including surrounding scar tissue) and majority of lead were explanted; all of the electrodes were not explanted, ¿recognizing the risk of additional dissection was certainly not warranted by any benefit of harvesting additional nerve lead wire. ¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102898


Title: Re: Voice/Speech
Post by: dennis100 on May 08, 2017, 01:27:21 AM
Model Number 105
Event Date 08/01/2014
Event Type Malfunction
Event Description
It was initially reported by the patient¿s mother that his vns setting changed after going through a body scanner. The patient had been kept there for a while and had been ¿swiped¿ with the security wand multiple times. When the patient left his voice had a constant ¿trill¿ but it has been more normal. The patient now reports that their voice no longer has a ¿trill¿ when they swipe their magnet. The mother later reported that the patient¿s signal frequency was at 15 hz when it had previously been set to 20 hz. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4061353


Title: Re: Voice/Speech
Post by: dennis100 on May 09, 2017, 12:51:45 AM
Model Number 304-20
Event Date 06/11/2014
Event Type Injury
Event Description
Additional information was received stating that the vns patient was also experiencing dysphagia and voice alteration associated with vns surgery and stimulation. The patient was given steroid injections to restore vocal function and to relieve dysphagia.

Event Description
It was reported that the patient was having vocal cord issues. It was reported that device diagnostics were within normal limits. It was reported that the patient has complained of this since surgery. The device output current is set to 0. 75ma. The patient believes the left vocal cord is experiencing paralysis. It was reported that the physician believes that the vocal cord paralysis is a result of the implant surgery and not related to device stimulation. The patient was seen by an ent and surgery is planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4149484


Title: Re: Voice/Speech
Post by: dennis100 on May 10, 2017, 01:15:48 AM
Event Date 09/26/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 high impedance and dysphonia. The generator was replaced prophylactically. Follow-up revealed that the high impedance and dysphonia was observed at the same time. The explanted devices have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4197298


Title: Re: Voice/Speech
Post by: dennis100 on May 11, 2017, 12:54:59 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Rptr indicated that pt presented for an office visit having hoarseness and not being able to feel stimulation. Diagnostic tests were performed at this office visit that resulted in high lead impedance, indicating a possible lead malfunction. Pt's device was subsequently turned off during this same visit. Good faith attempts for further info, including plan of action for pt, are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1004950


Title: Re: Voice/Speech
Post by: dennis100 on May 11, 2017, 12:55:37 AM
Model Number 102
Event Date 01/23/2008
Event Type Injury
Event Description
Reporter indicated that the patient was perceiving erratic and painful stimulation. In addition, reporter indicated that the magnet activation was unsuccessful in inhibiting the stimulation. As a result, the device was turned off; however, it was noticed that the patient, "still showed signs of stimulation with voice alteration. " therefore, the patient was admitted into er. It was reported that while in the er, the patient indicated that the "device is no longer kicking. " patient has requested removal of the vns system and surgery has been planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1001063


Title: Re: Voice/Speech
Post by: dennis100 on May 11, 2017, 12:56:19 AM
Model Number 302-30
Event Date 12/06/2007
Event Type Injury
Event Description
It was reported that a pt experienced hoarseness following explantation of vns device. The physician indicated that the hoarseness may be due to a laryngeal nerve injury sustained during the explant procedure since the entire lead and electrodes were removed. The nerve damage has not been confirmed. No medical intervention has been taken, and the pt is being given time to heal. A portion of the explanted lead was returned to the manufacturer, and no obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1000460


Title: Re: Voice/Speech
Post by: dennis100 on May 12, 2017, 01:03:38 AM
Model Number 303-20
Event Date 08/27/2008
Event Type Injury
Event Description
It was reported to the manufacturer that the vns patient has been experiencing severe hoarseness and has a low voice. The patient's cough has been reported to be "weak" as well. Follow-up revealed that the patient was diagnosed of vocal cord paralysis on the right vocal cord by an ent. Voice therapy has been prescribed to the patient for the paralysis. The patient's device was programmed to low settings to help with the paralysis as well. No other interventions will be taken. The physician alleged the paralysis to the implantation surgery of vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1217636


Title: Re: Voice/Speech
Post by: dennis100 on May 12, 2017, 01:04:40 AM
Model Number 102
Event Date 08/28/2008
Event Type Malfunction
Event Description
Initial reporter indicated that they had a vns patient in their hospital that reported that they felt "their vns was not working. " the patient was hospitalized for a low sodium related to their medications. The patient reported feeling many auras and using her magnet but not getting the "normal feeling she usually gets with her magnet. " the patent is not having any voice change with stimulation as she did in the past. It is unknown if the patient's "many auras" are over her pre vns rate. Good faith attempts are being made for further details surrounding the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236136


Title: Re: Voice/Speech
Post by: dennis100 on May 13, 2017, 03:25:18 AM
Model Number 102R
Event Date 07/01/2008
Event Type Injury
Manufacturer Narrative
See scanned page.

Event Description
It was reported that the vns patient was not able to feel normal and magnet mode stimulation and was experiencing a recent increase in seizure activity, relationship to pre-vns baseline unknown. Diagnostics were performed following the onset of the reported event and revealed normal device function with the end of service status set to no. The physician increased the output current and the pulse width and the patient subsequently experienced voice alteration. The device was then returned to the previous setting. A battery life calculation was performed and revealed that there was approximately 0. 43 years remaining until end of service is reached.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1190334


Title: Re: Voice/Speech
Post by: dennis100 on May 14, 2017, 12:47:48 AM
Model Number 102
Event Date 07/09/2008
Event Type Injury
Event Description
Pt had vagus nerve stimulator implanted sometime between 2005 and 2006 for seizure control. Pt complains of some discomfort and hoarseness during (four and a half months later) visit. Device explanted in 2008 because of suspected laryngeal nerve damage with resultant dysphonia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155973


Title: Re: Voice/Speech
Post by: dennis100 on May 15, 2017, 12:40:54 AM
Model Number 102
Event Date 07/11/2008
Event Type Injury
Event Description
Reporter indicated a vns patient's generator was disabled due to the pt's inability to tolerate hoarseness, coughing, and an increase in depression. The patient's depression level prior to being implanted is unknown. The physician has attempted to "play around with the settings; however the pt would sometimes come back on the same day or the next day to get it changed again. " an ent determined the hoarseness is not vocal cord paralysis. 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=1104308


Title: Re: Voice/Speech
Post by: dennis100 on May 16, 2017, 12:57:21 AM
Model Number 302-20
Event Date 03/19/2008
Event Type Injury
Event Description
Reporter indicated a vns pt experienced left vocal cord paralysis as a result of revision surgery. Follow-up with the physician revealed the pt's vocal cords are now "fine" and her "device is working fine". The pt is still experiencing slight hoarseness. 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=1074566


Title: Re: Voice/Speech
Post by: dennis100 on May 16, 2017, 12:57:53 AM
Model Number 302-20
Event Date 04/29/2008
Event Type Injury
Event Description
It was initially reported that the vns patient was experiencing pain and swelling in the neck, constant hoarseness, and apparent protrusion of the electrodes in the neck that has been occurring since initial implant with a worsening of symptoms over time. There was no report of trauma or manipulation reported. However, the generator is implanted near the armpit, and the patient "pushes" it to relocate the device for comfort. Further follow up with the treating physician revealed that vocal cord paralysis is suspected, however, the patient has not been seen by a surgeon to have the paralysis diagnosed. X-rays were taken to assess the system, and the strain relief bend did not appear per our labeling recommendations, as there was no strain relief bend present, and there was no tie-down located lateral of the anchor tether. The placement of the generator appeared normal. Recent diagnostic tests performed have revealed normal device function. The device remains on at this time and the patient is planning to see a surgeon for further evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069919


Title: Re: Voice/Speech
Post by: dennis100 on May 18, 2017, 12:47:58 AM
Model Number 302-20
Event Date 04/01/2008
Event Type  Injury   
Manufacturer Narrative 
Vns therapy system labeling lists left vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation.
 
Event Description 
Reporter indicated a vns pt was referred to an ent because since the initial implant, the pt "always has a scratchy throat. " the pt was diagnosed with left vocal cord paralysis. The pt states she does not feel normal stimulation, but she is able to feel magnet mode stimulation. The pt states she "is very happy with the vns device because she no longer has seizures. " 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=1057664


Title: Re: Voice/Speech
Post by: dennis100 on May 20, 2017, 07:51:38 AM
Model Number 302-20
Event Date 01/01/2009
Event Type  Injury   
Event Description 
Reporter indicated that the patient went to an ent physician to have his vocal cords examined due to hoarseness. Examination found that the patient had left vocal cord paresis. The patient is being treated with prednisone as the physician believes the postoperative inflammation of the area is causing the vocal cord paresis. This treatment has led the patient to claim that the issue is resolving, and would like the device activated soon. Since the device has not yet been activated, the event is not related to vns stimulation.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1313120


Title: Re: Voice/Speech
Post by: dennis100 on May 20, 2017, 07:52:54 AM
Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. Review of x-rays by manufacturer showed strain relief bend inadequate and no strain relief loop. No sharp angles were noted and no obvious lead discontinuities.
 
Event Description 
Initial reporter indicated that since she had revision surgery to provide extra slack in her lead, she had been having severe pain in her left ear, and along her jaw line. The pain did not correspond to stimulation on times. Reported when she has the pain, it is steady and it seems to get worse until at night, it is almost unbearable. Reporter indicated that using their magnet to stop the stimulation would resolve the pain. Programming changes were made lowering the pt's output current from 1. 75ma to 0. 75ma but the pain did not resolve. The pt reported the effects on their depression have been great with vns. Later, it was reported that their voice seems to be more affected when the device fires and they were experiencing a tightening of their airway, feeling of being very short of breath. Generator site pain was reported and movement of the generator in the pocket. The pt's physician felt the pt's shortness of breath was related to their pre existing anxiety and prior to all the reported events, the pt had not had any fall or injury. X-rays were reviewed on the pt's vns. The electrodes appeared implanted at approximately c6 in a normal orientation. The strain relief bend appeared inadequate in one view; the other view did not allow assessment of the strain relief due to poor contrast. No strain relief loop is noted. There was one tie down securing the lead. No other anomalies noted. There appeared to be a large amount of lead behind the generator which could not be assessed. No sharp angles were noted or obvious lead discontinuities. The pt was referred to a surgeon and had surgery to replace their vns generator, and a new generator was implanted higher on the chest. Lead placement was to be assessed at that time. Good faith attempts have been made for further details surrounding events and explanted product for analysis. Thus far no further info has been attained.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1314354


Title: Re: Voice/Speech
Post by: dennis100 on May 20, 2017, 07:53:55 AM
Model Number 303-20
Event Date 09/18/2008
Event Type  Injury   
Event Description 
It was reported that a vns patient was experiencing continuous voice alteration after implant surgery. The pt was seen by an ear/nose/throat physician who diagnosed the pt with "left true vocal cord paresis," which was believed to have been a side effect of implant surgery.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1222385


Title: Re: Voice/Speech
Post by: dennis100 on May 23, 2017, 01:22:57 AM
Model Number 102
Event Date 03/01/2008
Event Type  Injury   
Event Description 
Reporter indicated that a vns pt experienced a seizure increase, relationship to pre-vns baseline unk. The pt also did not feel stimulation as she did previously, had pain at the generator site, and there was an obvious change in her voice. Diagnostic test results were within normal limits. Exploratory surgery was performed and "it was immediately obvious that there was blood and fluids between the lead pins and the generator header. In the lead there was some fluid (liquid), on the place where the platinum electrode is located. " the generator was replaced and scar tissue was removed from the incision. Good faith attempts for additional info and product return have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1028162


Title: Re: Voice/Speech
Post by: dennis100 on May 23, 2017, 01:24:09 AM
Model Number 302-20
Event Date 01/01/2008
Event Type  Injury   
Manufacturer Narrative 
A serious injury did occur, but did not cause or contribute to a patient death.
 
Event Description 
Initial reporter indicated that her husband had ongoing problems with a continuously "gravel voice and inability to speak. " she reported the patient had damage to their left vocal cord. Interventions may be taken by the patient's treating physician to treat the vocal cord paralysis. The patient's physician reported that the event occurred after the patient's explant surgery. The patient is not currently implanted with an vns products.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1031158


Title: Re: Voice/Speech
Post by: dennis100 on May 24, 2017, 02:03:02 AM
Model Number 302-20
Event Date 04/11/2008
Event Type  Malfunction   
Manufacturer Narrative 
Device malfunction suspected, but did not cause or contribute to a death.
 
Event Description 
Initial reporter indicated that the pt had been in a recent car accident. System diagnostics testing showed the pt to have high lead impedance. A device malfunction is suspected against the lead. The pt also reported a "raspy voice all the time that gets worse during the day. " the pt did not want to have her vns programmed off despite the recommendations of the physician and mfr. Revision surgery is likely, but has not been scheduled at this time.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1047619


Title: Re: Voice/Speech
Post by: dennis100 on May 24, 2017, 02:04:08 AM
Model Number 302-30
Event Date 01/01/2008
Event Type  Injury   
Event Description 
Reporter indicated that she was diagnosed with vocal cord dysfunction. All attempts for further information from the patient's surgeon have been unsuccessful to date. The patient is currently receiving vns therapy and tolerating her stimulator per her attending neurologist.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1024455


Title: Re: Voice/Speech
Post by: dennis100 on May 24, 2017, 02:05:51 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


Title: Re: Voice/Speech
Post by: dennis100 on May 24, 2017, 02:07:16 AM
Model Number 302-20
Event Date 01/01/2006
Event Type  Injury   
Event Description 
It was reported to manufacturer that the vns patient was experiencing pain with the vns device. Further follow up with the physician revealed that the pt experienced throat pain and voice alteration following implantation of the device. The physician opted to initiate stimulation by slowly ramping up the setting to attempt to achieve efficacy. Once at a certain setting, the pt was experiencing painful stimulation in the throat and voice alteration with stimulation. The physician attempted to increase the setting further, however, the pain was not tolerable for the pt. The pt was referred to an ent surgeon and was subsequently diagnosed with left vocal cord paralysis. The pt is being monitored by the surgeon and the device remains on at this time, with no plans to increase the settings for the moment. The physician reported that diagnostic testing is routinely performed and the device is functioning within normal limits.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1040549


Title: Re: Voice/Speech
Post by: dennis100 on May 25, 2017, 12:47:52 AM
Model Number 302-20
Event Date 03/16/2009
Event Type  Injury   
Event Description 
Reporter indicated that the patient had been hoarse for approximately 2 days after his implantation procedure until present. The patient saw an ent physician that concluded that the patient's left vocal cord was paralyzed, and that he should see the surgeon who conducted the implant procedure. Information was received that the surgeon saw the patient, and concluded that the issue was a complication of surgery, and not related to stimulation as it occurred before the device had been activated. The patient was placed on steroids, and was recommended for speech therapy. The surgeon's office indicated they will monitor the issue until it is resolved.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1368747


Title: Re: Voice/Speech
Post by: dennis100 on May 25, 2017, 12:49:04 AM
Model Number 302-20
Event Date 02/25/2009
Event Type  Malfunction   
Event Description 
Reporter indicated a vns therapy pt felt a sensation that the leads may have moved more towards the midline. The pt did not experience "trauma, accident, or manipulation. " the pt "thinks she can still feel some stimulation, but just feels that her voice is rougher than before. " x-rays were reviewed by the physician, which revealed nothing "out of the ordinary or any evidence of movement. " however, both system and normal diagnostic test yielded high lead impedance. The pt's vns was not deactivated. Copies of the x-rays were reviewed by the manufacturer and no abnormalities were note that could have caused or contributed to the high impedance. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1418631


Title: Re: Voice/Speech
Post by: dennis100 on May 26, 2017, 12:10:06 PM
Model Number 102
Event Date 02/18/2009
Event Type  Injury   
Event Description 
It was reported to mfr that the vns pt recently had their vns lead and generator replaced in 2009. Five days following the revision surgery, the pt began experiencing hoarseness not associated with stimulation, and aspiration pneumonia. The pt was referred to an ent where a modified barium swallow test was performed and the results were normal. The pt was hospitalized for 5 days due to the aspirating pneumonia. The treating physician has reported that the pt's pneumonia has improved and the device has been turned on. Diagnostic tests have not been performed, as the settings are not yet at optimal values to perform the diagnostic tests. The physician is not certain of the relationship of the pneumonia to the re-implant surgery, however, it was noted that aspirating pneumonia is not out of the ordinary for the pt. Good faith attempts to obtain additional info from the treating physician have been made, but have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1357854


Title: Re: Voice/Speech
Post by: dennis100 on May 28, 2017, 02:01:42 AM
Model Number 302-20
Event Date 01/27/2009
Event Type  Injury   
Event Description 
Reporter indicated that a vns pt developed persistent dysphony after vns implant surgery, along with paralysis of the left vocal cord and a partial lesion of the left laryngal nerve. All attempts for additional info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409232


Title: Re: Voice/Speech
Post by: dennis100 on May 28, 2017, 02:03:26 AM
Model Number 101
Event Date 04/17/2009
Event Type  Injury   
Event Description 
Pt has had an implanted vagus nerve stimulator initially placed in 2000. It was used successfully and helped improve seizure control initially. A few years ago, pt had an mri with transmit and receive head coil and vns device was turned off before the test, as required. When this author tried to turn device back on after the mri, he complaint of pain and was more sensitive to vagus stimulation in general. Multiple attempts over time were not successful in getting his vns settings back to premri settings. He did however, continue to use the vns at lower settings with fair control of seizures. In 2009, this author received a phone call from pt, stating that he had throat pain and dysphagia each evening lasting about 3 hours for the preceding four days. He was seen by his epileptologist that day and vns was turned off with relief of pain and dysphagia. Pt had recalled that he had received diathermy treatments from a physical therapist at least on two known dates - the same month prior to original date, for treatment of plantar fasciitis. Pt states that he was not aware that the treatment involved diathermy and didn't recall the warning about diathermy and vns until original date. Further information obtained by dr. Reveals that patient noted some intermittent pain near the vns site after the first diathermy treatment. Over the past 1. 5 weeks at night, right after taking his bedtime pills, he would develop pain in upper chest and neck on left in the region of his vagus nerve stimulator. Then pain would last 1-2 hours, described as sharp, pulsating pain in left neck and upper chest. He also noted some increased voice hoarseness for a few days and increased coughing after taking pills. Pt was sent to the emergency room the same day, xrays of neck done and patient examined. No other complications were found. He was also seen by ent specialist in early the following month - no evidence of vocal cord paralysis found. Seizures worsened without the vns. Seizures used to be considered minor by patient, but without vns, seizures increased in frequency and were more intense. He would awaken from sleep 2 to 3 hours after onset with a startle with a change in breathing, feeling of anxiety, funny feeling in stomach. This could last 45 minutes intermittently before he would fall asleep. During remainder of night, sleep would have restless quality and he would awaken frequently with stomach feeling off. He would also feel more fatigued during day, requiring frequent rests, generalized weakness, and seizures occuring during daytime naps. Frequency of seizures increased to 1 to 3 times per day, on average of 5 to 6 times per week. Since vagus nerve stimulator was 9 years old and possibly contributing to the above symptoms, surgery was done the same month, to replace the vns generator. During surgery, system diagnostics were done with patient under anesthesia with results within normal limits. Device was removed -model 101, and upon visual examination by the neurosurgeon, one of the two screws -the one corresponding to the positive sign- was very loose and there was fluid within the cavity of where the lead contact should be going. A new vagus nerve stimulator was implanted - model 102r. The patient tolerated the procedure well. In the recovery room, the vagus nerve stimulator was turned on to very low settings. This did not trigger pain or other symptoms. Patient has since reported that sleep and seizures have improved in past 2 days.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386564


Title: Re: Voice/Speech
Post by: dennis100 on May 29, 2017, 02:55:48 AM
Model Number 302-20
Device Problems High impedance; Device displays error message 
Event Date 06/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device malfunction suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
Initial reporter indicated that they received a warning message when trying to perform diagnostics. Their pt was reported to be not feeling stimulation and feeling more depressed. Additionally, the pt would have voice alteration with stimulation up until approximately two weeks before their office visit showed high lead impedance. The pt was referred to their surgeon for revision surgery. X-rays were reviewed at the surgeon's office and it was reported that they did not see any hardware issues. The pt is pending insurance approval for surgery scheduling. Good faith attempts have been made for additional details surrounding event.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1465430


Title: Re: Voice/Speech
Post by: dennis100 on May 29, 2017, 02:57:15 AM
Event Date 05/01/2002
Event Type  Injury   
Event Description 
It was reported in a scientific article that a patient's voice presented hoarseness and discomfort during stimulation and was later diagnosed as vocal cord paralysis. Information provided from the patient's family stated that the patient "flipped the device under his skin". A twisted stimulator lead was seen on the chest x-ray and confirmed the patient's manipulation. Vagus nerve trauma was suspected and the patient underwent lead replacement as the implanted leads were found twisted, but at the time of surgery, the vagus nerve was found intact. The patient was observed for several months and the voice hoarseness never improved. The patient was referred to an otolaryngologist, and an ishiky thyroplasty was performed to medialize the paralyzed vocal cord. The procedure immediately restored the patient's voice with excellent quality.
 
Manufacturer Narrative 
Article: kalkanis, james, priya krishna, jose espinosa, and dean naritoku. "self-inflicted vocal cord paralysis in patients with vagus nerve stimulators. " (2002): 949-51.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1408578


Title: Re: Voice/Speech
Post by: dennis100 on May 30, 2017, 02:12:23 AM
Event Date 01/01/2004
Event Type  Injury   
Manufacturer Narrative 
Article citation: uthman bm, reichi am, dean jc, eisenschenk s, gilmore r, reid s, et al: effectiveness of vagus nerve stimulation in epilepsy patients: a 12-year observation. Neurology 63: 1124-1126, 2004.
 
Event Description 
Reporter indicated in a published journal article that a patient experienced permanent altered function of the ipsilateral vocal cord during vagus nerve stimulation. Follow-up with the reporter revealed he no longer had any information, as he had moved to another country.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425984


Title: Re: Voice/Speech
Post by: dennis100 on May 31, 2017, 10:54:45 AM
Model Number 101
Event Date 01/01/2002
Event Type  Injury   
Event Description 
It was reported that when the patient's vns device was initially turned on after surgery, he had intolerable voice alteration and vomiting occurring with stimulation. The device was turned off and the symptoms went away. Programming history was reviewed and shows that the device has been off since 2004. Attempts for further information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1456771


Title: Re: Voice/Speech
Post by: dennis100 on June 03, 2017, 12:23:07 AM
Model Number 102
Event Date 09/09/2009
Event Type  Injury   
Event Description 
It was reported by the surgeon that a vns patient was set up for consult, due to an infected wound at the generator site. Clinic notes were received on the patient, which indicated draining and debrided the tissue with antibiotics prior to the explant surgery. Additional adverse events were noted on the notes such as scarring, seroma, weight loss, bleeding, pain, changes in voice and swallowing, and throat spasms that reduced with programming changes. Information from the neurologist indicated the mentioned events were related to vns therapy, as no patient manipulation or trauma had been reported. Additionally, no changes in programming had been performed prior to the infection event, as the last programming change was done in february. Furthermore, information from the surgeon revealed both the generator and lead were explanted and not re-implanted. Moreover, an indication from the surgeon revealed that vns was helpful for the patient. At the moment, both the generator and lead are undergoing product analysis, as they were received after the surgery. Good faith attempt to obtain additional information regarding the cultures taken have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1488745


Title: Re: Voice/Speech
Post by: dennis100 on June 04, 2017, 12:59:44 AM
Model Number 302-20
Event Date 08/01/2008
Event Type  Malfunction   
Event Description 
It was reported by the pt's treating physician that pt has been experiencing increase in seizures (not above pre-vns) and longer seizures duration over the past one year. Pt also use to typically cough and had voice alteration with stimulation but she does not have those symptoms anymore. Further info from the physician indicated that diagnostics were done and it results in dcdc code of 0 on system test. It was informed to the physician a possibility of short circuit condition. Physician does not plan to take any intervention at this point other than monitoring the pt for a while and try to change settings. Physician believes that pt's symptoms are related to vns therapy and possibly related to the short circuit condition. Based on clinical symptoms and the diagnostic results of the pt's device, this file was found to be possibly related to a short-circuit condition.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1506025


Title: Re: Voice/Speech
Post by: dennis100 on June 05, 2017, 01:27:43 AM
Model Number 102
Event Date 06/01/2006
Event Type  Injury   
Event Description 
It was initially reported to manufacturer by the vns patient that the magnet had been taped over the generator for several months, because the stimulation causes gastric reflux, has made it difficult for him to breath, and causes voice alterations, which are uncomfortable. The patient additionally reported that he is experiencing sleep apnea, nightmares, coughing, and pain, even while the magnet was secured over the generator site to disable stimulation. Further follow up with the patient's treating physician revealed that they no longer follow the patient due to patient non-compliance and that the patient is 'difficult'. The physician stated that the patient did not mention any of the reported adverse events, while they were following the patient. The patient continues to contact the manufacturer, however, the patient has not provided the name of the physician that currently follows him. The patient stated that the vns device is now programmed off. The patient has indicated that he is seeking explantation of the device, however, it is unknown if the patient has contacted a surgeon.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1517127


Title: Re: Voice/Speech
Post by: dennis100 on June 05, 2017, 01:29:01 AM
Model Number 302-20
Event Date 09/30/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that diagnostic testing resulted in high lead impedance during an appointment with the neurologist. Additional info from pt clinic notes indicated the pt experienced an increase in seizures and could no longer perceive stimulation nor had the side effect of voice changes due to therapy after the high impedance was found by the neurologist. No recent trauma to the area has been reported and the pt was set up for revision surgery. Additional info was received from a company rep indicating the pt underwent surgery and info from the surgeons office further clarified the pt's lead was replaced due to the reported high impedance. Good faith attempts to obtain additional info and product return have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1533074


Title: Re: Voice/Speech
Post by: dennis100 on June 05, 2017, 11:36:39 PM
Model Number 303-20
Event Date 07/29/2009
Event Type  Injury   
Event Description 
The pt's treating neurology office reported that the pt was implanted with their vns in 2009 and since that time has had hoarseness. The vns has not been programmed on. Further info was attained from the pt's ent physician. Reporting the pt had no cough, no swallowing issues, and no drainage from incision sites, but is persistently hoarse. No reflux noted. The ent physician was unable to perform mirror laryngoscopy related to the pt's gag reflex. Hoarseness on left side was reported to be likely due to possible left vocal cord paralysis or palsy. The pt was scheduled for flexible laryngoscopy under anesthesia related to their gag reflex. At this time good faith attempts have been made for additional details surrounding the event to determine the outcome of the laryngoscopy and if any interventions are planned. No further info has been provided.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1521494


Title: Re: Voice/Speech
Post by: dennis100 on June 05, 2017, 11:38:22 PM
Model Number 302-20
Device Problem High impedance 
Event Date 09/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a suspect, yet questionable, lead discontinuity. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported to manufacturer that the vns patient's device revealed high lead impedance from a system diagnostic test performed at a follow up visit. Prior to the result of high lead impedance from the system diagnostic test, the patient reported feeling voice alteration with stimulation, which was not occurring with stimulation previously. X-rays were taken to assess the continuity of the lead, and were sent to the manufacturer for review. Review of x-rays revealed a suspect, yet questionable, lead discontinuity visualized in the electrode bifurcation region. The patient's mother reported that the patient did experience mild trauma to the left neck while playing with the younger brother (b) (6) 2009. It is not clear if this trauma directly affected the device functionality at the time as the device was not tested until early (b) (6) 2009. The site reports that the patient's device has been programmed off and revision surgery is likely.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1542372


Title: Re: Voice/Speech
Post by: dennis100 on June 06, 2017, 12:22:56 AM
Model Number 103
Device Problem No Information 
Event Date 10/01/2009
Event Type  Malfunction   
Event Description 
Summary: it was reported that a vns pt was experiencing pain and burning sensation on the generator area along with a tingling feeling in the left neck and ear area. Further info from the treating neurologist indicated that the events were occurring during stimulation and the pt had to go to the er because the pain was so bad. No mentioned interventions were taken at the er other than x-rays and ct scan. Further info from the pt indicated that turning the device off using the magnet ameliorated the reported events. Current system diagnostics provided by the neurologist were ok/ok/3400/ 10 years and both normal and magnet diagnostics were ok. Furthermore, the pt reported a choking sensation when doing a magnet swipe which due to the magnet settings running at higher output and also the fact that the on time is 60 seconds rather than 30 seconds. Furthermore, it was also noticed that the pt had voice alteration issues as current settings were 2/15/130/30/3. At the moment, no pt manipulation or trauma has been reported that could have had contributed to the reported events and no device anomalies are noted as the device is functioning as intended. Further recommendations were made from a company representative to have the device turned off and allow rest to the pt and then program the pt back to intended settings. The recommendation was taken by the neurologist and the pt was programmed off. A week later, the pt was reprogrammed to low setting of. 25 ma but the pt could not tolerate the settings. Interventions were to have the generator and lead replaced due to a suspected malfunction with the devices from the neurologist. Additional info was received in the form of clinic notes from the treating neurologist. A review of the received notes revealed the pt was experiencing the following adverse events prior to having vns explanted. Furthermore, a note was made indicating the pt felt discomfort once the device was re-activated by the neurologist in less than 5 minutes and was recommended vns re-implant due current vns device "not right. " info was received from the treating nurse indicating the reported events of burning sensation, pain in the neck, jaw, left ear, and tingling sensations were related to vns stimulation and the neurologist believe something was wrong with the vns device. The pt's generator was explanted due to painful stimulation and at the moment, good faith attempts to obtain product return have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553673


Title: Re: Voice/Speech
Post by: dennis100 on June 07, 2017, 12:22:10 AM
Model Number 302-20
Event Date 01/20/2010
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that high lead impedance was read in system diagnostics during a follow up visit with the treating neurologist. The patient had reported an assault and trauma to the neck area in (b) (6) 2009. System diagnostics were fine (ok/ok/1/no) in (b) (6) 2009 after the incident and the high lead impedance (7/limit/high/no) was encountered on (b) (6) 2010 after performing both a system and normal mode diagnostic test. The device was programmed off by the neurologist and the patient was recommended for x-rays. X-ray review from the manufacturer revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. Furthermore, no acute angles or discontinuities were observed in the visualized portion of the device, though a small portion of the lead behind the generator could not be visualized or assessed. The patient's positive electrode appeared to be misaligned with the negative electrode, which may be due to electrode/nerve detachment. A clinic note was received from the office of the treating neurologist at the time of the incident which indicated the patient was grabbed by the throat and after he was released, he felt the lead was moved and was hoarse due to the trauma. Follow up with the treating neurologist revealed the patient was doing well with no adverse events and revision surgery had been scheduled and was likely to occur.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1613594


Title: Re: Voice/Speech
Post by: dennis100 on June 07, 2017, 08:48:51 AM
Model Number 302-20
Event Date 01/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
It was reported to mfr that the vns pt's device revealed high lead impedance when both system and normal mode diagnostic tests were performed at a follow up visit. The pt is still continuing to experience voice alteration. The last time the pt was seen for follow up was in (b) (6) 2009 where device diagnostics revealed normal device function. Good faith attempts to obtain additional info from the physician are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1613556


Title: Re: Voice/Speech
Post by: dennis100 on June 08, 2017, 04:56:39 AM
Event Type Injury
Event Description
It was reported in an article that a patient implanted with vns therapy for depression had to have the device removed due to a hoarse voice. No other information regarding the issue was provided within the article, and attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1603738


Title: Re: Voice/Speech
Post by: dennis100 on June 08, 2017, 11:16:43 AM
Model Number 300-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a vns pt experienced an increase in seizures due to unk reason. The pt's parents had not noticed the presence of cough and voice alteration with stimulation after the pt's sudden increase in seizures. Furthermore a dcdc of 0 was read at a necessary follow up with the treating neurologist in nov 2009 and x-rays along with evoked potentials and normal mode diagnostics resulted in terms of normality. The pt's generator was left on as advice was given from a company rep to maintain the device on. The treating neurologist at the time believed the increase in the pt's seizures was due to the pt's natural disease progression. The neurologist had plans to replace the vns system, but the given advice to leave the generator on changed the physician's perspective. A review of the pt's programming history indicated system diagnostics were previously of dcdc 1 and dropped to dcdc 0 in the span of approx 2 yrs (from (b)(6) 2007 to (b)(6) 2009). Additional info was received through a company rep from the treating physician. The physician indicated the pt's seizures were of unk pre-vns level at the time of the dcdc of 0 and interventions taken for the dcdc of 0 were to program the pt's device off. At the moment no surgical interventions are planned as the pt is now receiving a different drug therapy and is seizure free. Nonetheless, review of the evoked potential reading by the mfr revealed normality as expected normal pulse (a clear positive square wave followed by a charge-balanced negative phase). However, the changes in clinical symptoms at the time are likely indicative of a short circuit issue along with the consideration of a drop in dcdc code from 1 to 0.

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=1652988


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 12:53:34 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 05/05/2017
Event Type Injury
Manufacturer Narrative

Event Description
A patient reported that vns gave her vocal cord dysfunction. She stated it mimics asthma or choking. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600076


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 12:54:29 AM
Model Number 303-30
Device Problem No Known Device Problem
Event Date 04/20/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing hoarseness following a vns generator replacement surgery. Events surrounding the surgery were reported in medwatch report 1644487-2017-03813. The experience of hoarseness was known to not be related to vns stimulation at the time of the observation. The patient¿s provider(s) assessed that the patient's symptom represented unilateral vocal cord paralysis. An analysis of labeling showed that left vocal cord paralysis is a potential adverse event possibly associated with surgery or stimulation. However, no assessment by a medical provider an the relation of the vocal cord paralysis to vns has been received to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6599811


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 01:57:38 AM
Model Number 300-20
Device Problem Fracture
Event Date 04/14/2017
Event Type Malfunction
Event Description
It was reported that during an office visit on high impedance was observed as a result of a diagnostic test. The settings were not changed at that time. The patient reported that for the past 1-2 weeks she had been experiencing an increase in seizures and left jaw discomfort. She also had been stuttering for the previous 2 days and the vns magnet was not working the same as before. The patient was referred for surgery to address the high impedance but no surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6584365


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 07:19:42 AM
Model Number 304-20
Device Problem High impedance
Event Date 04/19/2017
Event Type Malfunction
Event Description
Patient's device showed high lead impedance warning of about 7500 ohms. Settings were increased and patient had cough and hoarse voice. So it is believed that the patient is getting some stimulation. No additional relevant information has been received to date. A review of device history records for the generator and lead shows that no unresolved non-conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6567307


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 07:21:13 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/07/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported by an er physician that the patient was seen in the er due to feeling the device constantly going off. The magnet was placed over the generator to disable the device and it was stated by the patient that the stimulation did not stop. It was later reported that the magnet did disable the device and that the patient had vocal cord paralysis, chocking, and hoarseness with vns stimulation. There was also pain reported that occurred when the device was on and off. The patient did not want the device disabled so the only settings change was the lowering of the on time. The diagnostics for the device were reported to be ok when the patient was in the er. The patient went in for a follow up visit with the neurologist and the diagnostics were again ok. The neurologist believes the issues are due to the patient taking longer to recover from the vns surgery or possibly a psychosomatic event caused by anxiety with vns stimulation. X-rays were performed, and a review by the physician revealed no issues. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6569513


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 11:02:43 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/05/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported (b)(6) 2013 that a patient had an increase in seizures and she felt that the device stopped working as she no longer experienced voice alteration and was unable to feel the magnet swipe. The patient had been referred for battery replacement as it was suspected the device was at end-of-service. No further information was received at that time. Clinic notes were later received on 04/17/2017 which provided that the vns battery was checked and the battery is active. An estimate of battery life calculation performed 04/17/2017 predicted the battery was not depleted at the time of the increase in seizures. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6564259


Title: Re: Voice/Speech
Post by: dennis100 on June 09, 2017, 01:26:34 PM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/13/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported by a patient that she had not had her device checked in years. She stated she can tell the battery must be getting low because the depression is returning and her voice alteration is not as noticeable. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6556293


Title: Re: Voice/Speech
Post by: dennis100 on June 10, 2017, 01:17:14 AM
Model Number 300-20
Device Problem Fracture
Event Date 04/06/2017
Event Type Malfunction
Event Description
It was reported by the physician that high impedance was detected on the patient's device by both normal and system diagnostics. X-rays found no evidence of a lead fracture. The physician believed that the patient was not likely receiving full programmed stimulation and the patient and father believed that the patient's voice change with stimulation had been prominent for around the last year. There was no known trauma or manipulation to the device. No known relevant surgical intervention has occurred to date. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6539305


Title: Re: Voice/Speech
Post by: dennis100 on June 10, 2017, 01:18:26 AM
Model Number 302-20
Device Problem Fracture
Event Date 02/01/2017
Event Type Malfunction
Event Description
It was reported that the patient had been feeling shocks that caused the patient to be unable to talk and barely breathe. The patient experienced such painful shocks that he had to be restrained at the emergency department. The written notes from the physician stated that he thought the "ground pulled off the nerve" without any clarification. The patient had full revision surgery due to the painful stimulation, and the physician later reported that there was an observed lead break during the surgery. However, diagnostics were within normal limits immediately prior to the surgery. The explanted product has not been received to date.

Manufacturer Narrative

Event Description
The generator was received into analysis. The lead was not received from the explanting hospital. The device performed according to functional specifications. Analysis concluded 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=6551020


Title: Re: Voice/Speech
Post by: dennis100 on June 10, 2017, 01:19:30 AM
Model Number 304-20
Device Problem No Known Device
Problem Event
Date 03/01/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient¿s vns had caused vocal cord dysfunction. No further information on this report could be clarified at the time of the initial report. Follow up with the office of the treating neurologist showed that the patient¿s vns registered system impedance within normal limits. No further information could be provided at that time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6535831


Title: Re: Voice/Speech
Post by: dennis100 on June 11, 2017, 08:25:02 AM
Model Number 302-20
Event Date 01/01/2010
Event Type  Malfunction   
Event Description 
It was reported to manufacturer that when the vns pt was seen for a follow up appointment, the pt noted that the normal voice alteration she has during stimulation of the device has not been as intense as it has in the past. The physician performed both normal mode and system diagnostic tests which both revealed high lead impedance, dcdc =7. The physician programmed the device off when the high lead impedance result was received. There was no report of any trauma or manipulation to the device site prior to the onset of the less intense voice alteration and the subsequent high lead impedance test result. The physician noted that x-rays will not be taken. It is unk if revision surgery will occur, however, good faith attempts to obtain additional info have been made, but no info regarding revision surgery has been received to date.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1675310


Title: Re: Voice/Speech
Post by: dennis100 on June 12, 2017, 12:55:03 AM
Model Number 302-20
Event Date 03/19/2010
Event Type  Malfunction   
Event Description 
It was reported that a pt presented high lead impedance readings during a routine office visit. The pt also stated she felt something in her neck when stimulation occurred and had mild hoarseness that began recently. There were no reports of manipulation or trauma; however, the pt has lost a significant amount of weight following a weight-loss surgery. Two sets of x-rays were sent to the mfr for review and no lead discontinuities or other causes for high lead impedances were found; however, a portion of the lead was behind the generator and could not be assessed. Good faith attempts to obtain additional info from the pt's physician have been unsuccessful to date.
 
Manufacturer Narrative 
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1661651


Title: Re: Voice/Speech
Post by: dennis100 on June 12, 2017, 12:56:28 AM
Model Number 102
Event Date 12/29/2006
Event Type  Injury   
Event Description 
It was initially reported that the pt was experiencing mild voice alteration with stimulation. It was not believed that a device malfunction was occurring. The painful stimulation that the pt was experiencing was said to "may be due to a massive shoulder operation that the pt had in the near past. " later, it was described that "immediately after the implantation, the pt described a tingling sensation with stimulation. The tingling spread in his left arm and was described as pain with increasing stimulation intensities. The location of stimulation was checked with a plain x-rays, which were not provided to the mfr for review. Subjective and noticeable hoarseness with stimulation was very suggestive of a proper location of the stimulation. The pt did not tolerate the stimulation well and in (b) (6) 2007, experienced pain in the arm with stimulation when 1. 0ma was reached. There was only a quantitative change after reduction of the amplitude or the pulse width during 2008. In the middle of 2009, he noticed involuntary movements of the left arm with each vns-pulse. Therefore, the vns-generator was switched off. On (b) (6) 2010, the vns-stimulator was explanted due to the pain events. At this stage the pt, had clearly visible contractions of the biceps brachii and the deltoid muscle with each stimulation (short test period only). After the operation, he is feeling well again. " the pt was not reimplanted and the device was discarded by the hospital so it would not be returned for product analysis. It is unk if the pt was experiencing a serious injury due to the events or if the device was removed for pt comfort. Review of the programming history available in the mfr's database, showed the last known diagnostics performed were at the time of implant on (b) (6) 2006, which were within normal limits.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662336


Title: Re: Voice/Speech
Post by: dennis100 on June 23, 2017, 01:35:41 AM
Event Date 03/01/2010
Event Type Injury
Event Description
It was initially reported by the patient's mother that the patient experienced high blood pressure after vns surgery. Patient took blood pressure medicine and is doing better now. Physician was not sure if the high blood pressure was due to vns, but it occurred right after the surgery. She also mentioned that the pt's voice is down to a whisper now. The device has not been turned on as yet. Treating physician believes that the pt has vocal cord paralysis. Good faith attempts to obtain add'l info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1722861


Title: Re: Voice/Speech
Post by: dennis100 on June 25, 2017, 12:29:15 AM
Model Number 302-20
Event Date 03/09/2010
Event Type Injury
Event Description
It was reported at a follow up appointment with the treating neurologist that the recently implanted vns patient had experienced a lot of hoarseness after vns placement. The patient's primary care physician referred the patient to an ent approximately 3 weeks following initial vns implantation surgery and the patient was told she 'had some vocal cord paralysis". At the follow up appointment with the neurologist, the patient's mother reported that the patient's voice is just about back to normal. At a more recent follow up appointment with the neurologist, it was noted that the patient's voice is fine at this time. There was no report of any interventions taken by the ent for the vocal cord paralysis. Diagnostic testing has not been done by the neurologist at this time, however, a device deficiency is not suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1709837


Title: Re: Voice/Speech
Post by: dennis100 on June 27, 2017, 04:09:02 AM
Model Number 103
Event Date 05/28/2010
Event Type Injury
Event Description
It was reported that the vns patient has been experiencing worsening voice alteration and swelling in the neck region since vns implantation surgery which prompted the patient to visit the ent for an evaluation. The ent diagnosed the patient to have developed vocal cord paralysis on the left vocal cord. This event is suspected to have begun two days following vns implantation surgery. Diagnostics performed on the patient's device revealed proper device function. The event is estimated to spontaneously resolve on its own accord, therefore, no interventions were planned or taken for this event. While the event has been expected to be temporary by the ent, it is unknown at this time if it resolved completely. Follow-up revealed that the voice alteration has improved when the patient was seen by the neurologist recently.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1749839


Title: Re: Voice/Speech
Post by: dennis100 on June 27, 2017, 06:34:16 AM
Model Number 302-20
Event Date 07/01/2010
Event Type Malfunction
Event Description
Reporter indicated the patient is being referred to (b)(4) for testing of nerve function under sedation prior to vns revision surgery being performed. A surgery date has not been set to date, but appears likely.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
All attempts to the reporter for additional information regarding the vocal cord damage have been unsuccessful to date.

Event Description
Additional information was received indicating that the patient is being referred for replacement surgery. Surgery is likely but has not occurred to date.

Event Description
It was reported that the vns pt was seen for follow up with a new nurse practitioner, and when a system diagnostic test was performed, high lead impedance resulted. The device was programmed off and the pt was sent for x-rays to assess the continuity of the device. The x-rays were sent to mfr for review where there were no obvious anomalies observed, and there were no gross lead fractures noted on the portion of the lead that was able to be assessed. Further follow up with the nurse indicated that the pt had been experiencing an increase in seizures for a few months. The pt was growing and the mother had reported that the magnet did not seem to be working to help the seizures during these few months. The physician who was following the pt at the time had been increasing the pt's medication, with the thought that because the patient was growing and gaining weight, this was the best plan of care for the pt. The vns device was not checked during this time period. There was no report of trauma or manipulation to the device site. The pt's mother has opted to wait until a later date to proceed with surgical intervention to further investigate the high impedance.

Event Description
Reporter indicated that vns lead and generator replacement surgery for the high lead impedance is no longer likely as the patient has left vocal cord damage. Attempts to the reporter for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1823602


Title: Re: Voice/Speech
Post by: dennis100 on June 27, 2017, 11:45:30 AM
Model Number 302-30
Event Date 07/15/2010
Event Type Injury
Event Description
It was initially reported that a pt has experienced hoarseness since implant which has not significantly improved. The physician indicated that he suspects the recurrent laryngeal nerve fibers were within portions of the nerve wrapped by the lead and that the pt has left vocal cord paralysis as a result. The pt will be seen by another physician for further eval. The physician stated that he sees no point to not program the pt's device on at this point and will be doing so in the immediate future. 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=1822471


Title: Re: Voice/Speech
Post by: dennis100 on June 28, 2017, 01:46:13 AM
Model Number 302-30
Event Date 07/20/2010
Event Type Injury
Event Description
It was initially reported that a vns patient was admitted to the hospital due to sharp pain in his throat when he swallows and voice alteration. The issues began to occur after the patient was doing pushups. The patient's device checked at the hospital and was found to be functioning fine. The patient followed up with his neurologist a few weeks later and diagnostics were performed again indicating normal device function. The patient was doing well. The physician was not able to obtain any additional information on either the pain or voice alteration from the treating hospital. 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=1817119


Title: Re: Voice/Speech
Post by: dennis100 on June 30, 2017, 07:55:26 AM
Model Number 304-20
Event Date 07/01/2010
Event Type Injury
Event Description
It was reported that the pt was experiencing voice alteration since vns implant. The vns had not been turned on yet. The surgeon could not tell any difference in pt's voice when she spoke to him on the phone. Pt was evaluated by an ent who diagnosed pt with left vocal cord paralysis and recommended that the pt have device explanted. Follow-up reveals that the pt's voice is fine unless he yells or strains. His voice is healing and the paralysis and voice alteration will resolve over time. Pt may be following up with another ent and the device is still not turned on. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833670


Title: Re: Voice/Speech
Post by: dennis100 on July 02, 2017, 01:44:13 AM
Model Number 302-20
Event Date 08/27/2010
Event Type Malfunction
Event Description
It was initially reported that high lead impedance was observed during the pt's appt. The pt was programmed to 0. 25 ma and was increased to 0. 50 ma, but was unable to tolerate due to pain. The pt was referred for x-rays and disabled at that time. Diagnostics were not said to have been performed, but was instead seen as a warning message following interrogation of the device. Review of clinic notes received indicated that the pt was increased to 0. 50 ma on (b)(6) 2010 with only reported voice alteration and being uncomfortable. The pt was later decreased back to 0. 25 ma due to the adverse issues on (b)(6) 2010. The pt's duty cycle was increased on (b)(6) 2010 with no high impedance message mentioned at this time. Clinic notes dated (b)(6) 2010 show "high impedance of 9220 ohms was detected. " diagnostics were performed on (b)(6) 2010, which resulted in high lead impedance. The pt was referred for lead revision at that time. During revision surgery, it was noted that the pt was stated to be a twiddler and the leads were observed to be "kinked" due to manipulation. Good faith attempts to obtain the explanted pulse generator and leads have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury. Pt manipulation is believed to be the likely cause at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1859789


Title: Re: Voice/Speech
Post by: dennis100 on July 02, 2017, 01:45:13 AM
Model Number 302-20
Event Date 08/06/2010
Event Type Injury
Event Description
It was reported that a vns pt experienced voice alteration and hoarseness after vns implant surgery. The pt's device was not programmed on at the time of the events. The pt's device was programmed on by the treating neurologist, who indicated the pt's hoarseness was related to surgery and referred the pt to an ent. F/u from a company rep revealed the pt visited the ent and results were positive for vocal cord paralysis. At the moment, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date. Moreover, additional information was rec'd from the surgeon's office through a company rep indicating the x-rays were taken. Review of the x-rays by the surgeon indicated that in his opinion the electrodes were not aligned properly. Moreover, the reported x-rays have not been rec'd by the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1846175


Title: Re: Voice/Speech
Post by: dennis100 on July 02, 2017, 06:30:35 AM
Model Number 302-20
Event Date 08/01/2010
Event Type Injury
Event Description
It was reported by the treating neurologist that the vns epilepsy pt was being evaluated for investigation of her respiratory status while she was also being evaluated for surgery that was scheduled to prophylactically replace the vns pulse generator. The surgery was cancelled as the surgical team determined that the pt's respiratory status was compromised, and the pt required hospitalization for treatment at that time. The patient was seen by a pulmonologist, who reported to the neurologist that the pt's respiratory issues, which were initially thought to be asthma, but after eval, it appears that the issue is episodes of tachypnea with respiratory rates of 50/minute. Additionally, the patient has been experiencing dyspnea, which is unrelated to asthma, and is not relieved by albuterol. Add'l info from the pt revealed that the pulmonologist, who, per the pt, told her that the left airway was still at a sub-optimal level, and the specialist was wondering if the electrodes placement could be moved so that it is "not in the way of breathing. " there was some discussion, per the pt, of exploring the left neck region surgically; however, this has not been confirmed by the patients treating neurologist. The patient has been re-scheduled for surgery to replace the pulse generator and possibly explore the neck region, which is to occur in october. Add'l info was received from the pt's treating neurologist that prior to the pt's surgical eval, the pt was asymptomatic for any side effects from vns stimulation. The patient did complain of intermittent hoarseness with stimulation. In addition, the physician noted that the patient has pre-existing respiratory issues, prior to having been implanted with the vns device in 2002. The respiratory side effects were exacerbated by stimulation when the physician attempted to increase the output current to control the patient's seizures better. The physician stated that the device settings have always been kept at 'lower settings' so as to minimize any contribution that stimulation may have on the existing respiratory issues. The vns device setting has recently been decreased to an output current of 0. 75ma, a magnet output current of 1. 25 ma, on time of 30 seconds and off time of 3 minutes. The physician noted that the patient was at the above noted settings for approx 2 years with no complaints. Recent diagnostic testing done on the patient's device has revealed normal device function. In addition, the neurologist reported that the patient also has been evaluated by an ent, where left vocal cord paralysis was diagnosed by a ct scan of the neck. The physician noted that "since the cord appears to be paralyzed, it looks like this may be a nerve compromise from the lead" and it is not associated with stimulation of the vns device. The neurologist continues to monitor this patient's events along with the other physicians involved in the patient's care. Add'l info is expected to be communicated by the neurologist regarding the findings of the surgical procedure and whether the respiratory issues are related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845930


Title: Re: Voice/Speech
Post by: dennis100 on July 04, 2017, 12:33:02 AM
Model Number 304-20
Event Date 08/26/2010
Event Type Injury
Event Description
It was initially reported by the surgeon that the vns pt that was showing vocal cord paralysis with worsening voice hoarseness and he was planning to do a lead revision to alleviate the issue, but this was not performed. The surgeon had started her on oral steroids to see if this will help, but later provided a steroid injection. The surgeon indicated that it was likely related to the surgical procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1867675


Title: Re: Voice/Speech
Post by: dennis100 on July 04, 2017, 12:33:49 AM
Model Number 302-20
Event Date 01/01/2010
Event Type Injury
Event Description
It was initially reported that the vns pt was experiencing some coughing, so the pt's device was disabled. The coughing was said to be continuing after the disablement of the device. It was later indicated by the treating neurologist that the felt coughing was cause by scar tissue paralyzing the vocal cords and causing hoarseness. The pt is seeing a speech therapist. The pt's hoarseness was also said to be improving since disablement. X-rays were said to have been taken, which was said to be normal, but have not been forwarded to the manufacturer for review. A search performed in the manufacturer's programming history database resulted in last known diagnostics performed were within normal limits. 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=1875934


Title: Re: Voice/Speech
Post by: dennis100 on July 04, 2017, 03:46:25 AM
Model Number 302-20
Event Date 06/30/2010
Event Type Injury
Event Description
It was reported that a vns pt experienced vocal cord paralysis. The pt was implanted with vns on (b)(6)2010 and the vocal cord occurred a month after surgery. The issue initially occurred as spontaneous hoarseness that was continous while the pt's device remained off. The pt was referred to an ent physician who diagnosed the pt with definite vocal cord paralysis. The ent placed the pt under anesthesia and injected the pt with steroids. Moreover, additional info from a company rep revealed that the implanting surgeon generally takes a long time to implant the vns electrodes in pts; hence the hoarseness could be related by the long exposure time to the nerve. Additional info was received from the office of the treating neurologist indicating the cause of the pt's vocal cord paralysis was related to vns surgery. Additionally, info from the treating neurologist through a company rep indicated that the pt will be programmed on in the future but no date was given. Good faith attempts to obtain additional info from the treating ent have been unsuccessful to date.

Manufacturer Narrative
Date of event, corrected data: additional information indicates that event began on date of implant.

Event Description
It was reported that the vns patient underwent surgery to explant her generator and lead on (b)(6) 2014 due to vocal cord paralysis and dysphagia. The device's normal mode output current had previously been disabled but the magnet mode output current was left programmed on. Pre-operative diagnostic results showed normal lead impedance at the time. The patient was diagnosed with vocal cord paralysis and had her throat dilated. Dysphagia was first observed on the day of implant and is believed to be due to vagal nerve damage during the implant procedure. The patient also began experiencing coughing and voice alteration since implant. Dysphagia was not occurring with stimulation and the patient did not have a medical history of dysphagia prior to vns. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1864291


Title: Re: Voice/Speech
Post by: dennis100 on July 04, 2017, 10:56:43 AM
Model Number 103
Event Date 10/01/2010
Event Type Injury
Event Description
It was initially reported by the physician that the patient was being referred to the surgeon to look at the placement of the electrode and see if there is a better option because the patient is complaining of severe hoarseness. They want to have the electrodes relocated as it is so close to his vocal cords that you can barely hear him talk when it goes off and it really affects his day to day living. Patient has been great to vns so he is motivated to have the revision done. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909634


Title: Re: Voice/Speech
Post by: dennis100 on July 05, 2017, 12:22:40 AM
Model Number 103
Event Date 01/01/2010
Event Type Injury
Event Description
It was initially reported by the pt that after the pt was turned up to 0. 50ma, she began to experiencing voice alteration and feelings that her "heart was racing," but have since resolved. The pt reports that she is still having grand mal seizures, but her postictal period is improved from 4 days of headaches to only 1. 5 days. The pt has since lost her insurance and has been unable to visit with a neurologist on her vns management. Her previous neurologist was unaware of the reported issues so they were unable to comment. The pt also has a history of refusing to take her paxil, so it is not clear if this may be a contributory factor. 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=1905610


Title: Re: Voice/Speech
Post by: dennis100 on July 05, 2017, 11:22:01 AM
Model Number 302-20
Event Date 06/01/2008
Event Type Injury
Event Description
It was reported by a surgeon that a vns pt experienced voice disturbance that occurred approx 6-7 months after her vns surgery. The pt recently had a videostrobe which revealed improved glottic closure. The true vocal fold did appear temporarily fixate during active stimulation by the vns implant. Add'l info was received through clinic notes dated (b)(6) 2008 in which the pt reported verbal hoarseness. At the following appt on (b)(6) 2008, the pt reported headache after the device was adjusted vocal cord edema and verbal hoarseness. Hoarseness of voice was noted on (b)(6) 2008. On (b)(4) 2008, it was indicated, the pt experienced left vocal cord paralysis. The vocal cord was injected with a gel to prevent choking. 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=1894942


Title: Re: Voice/Speech
Post by: dennis100 on July 07, 2017, 08:12:10 AM
Model Number 302-20
Device Problem Fracture
Event Date 04/25/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was no longer experiencing voice alteration, so the physician checked the patient's vns device. The physician interrogated the device and received a high impedance warning. The patient stated that he had not felt the vns working for about a month, and his seizures became more intense and longer and were no longer aborted by the magnet. X-rays were performed, and the physician did not identify a lead fracture. The physician referred the patient for surgery to correct the high impedance. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6666126


Title: Re: Voice/Speech
Post by: dennis100 on July 08, 2017, 01:19:29 AM
Model Number 302-20
Device Problem Fracture
Event Date 05/19/2017
Event Type  Malfunction   
Event Description
Report was received that stated a patient was being referred for full revision surgery. The reason for revision was reportedly due to high impedance. It was also reported that the patient had been experiencing constant hoarseness before high impedance was observed. The patient's mother had also suggested the patient had experienced an increase in seizures. However, information received from the physician disputed this report and stated the patient was not experiencing an increase in seizures but was experiencing an adverse event. Further information was received that the patient's device remained on despite the observation of high impedance. No known surgical intervention has occurred to date. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6648280


Title: Re: Voice/Speech
Post by: dennis100 on July 08, 2017, 04:03:58 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 02/21/2017
Event Type  Injury   
Event Description
Since generator replacement surgery, patient has been experiencing constipation, urinary retention, decreased vocal volume and loss of appetite. These symptoms resolved when a magnet was placed over the generator and returned when the magnet was removed. Grandparents presented video recorded just prior to being turned off and following turning back on that support this (patient's voice volume returned to a normal baseline). At the time of generator replacement, patient had not experienced the above side effects. At the time of replacement, the patient¿s new vns settings were the same as the previous settings. The physician decreased the pulse width based on this observation and grandparents are to continue monitoring the patient. No additional relevant information has been received.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6639108


Title: Re: Voice/Speech
Post by: dennis100 on July 08, 2017, 08:55:12 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 02/14/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient who was recently implanted was having vocal cord issues, provided to be vocal cord dysfunction. It was stated that the patient was a tough case in surgery as he had tried to attempt suicide multiple times in his life and he had a lot of scarring on his neck. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6612210


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2017, 02:14:00 AM
Model Number 103
Event Date 11/01/2010
Event Type  Injury   
Event Description
Clinic notes reiceed reported that the patient had generator repositioning surgery on (b)(6) 2010. On (b)(6) 2014, system diagnostics were within normal limits with impedance value of 2826 ohms.
 
Event Description
It was reported that it is believed that a non-absorbable suture was used to secure the generator to the fascia during implant.
 
Event Description
It was reported by a company representative that a vns patient indicated her device was not working a couple of weeks after being implanted on (b)(6) 2010. The patient additionally reported her device had migrated under her armpit and reported she could no longer feel stimulation (unknown start date). The patient indicated that the device was working on (b)(6), and she would have voice alterations with stimulation. However, the patient stated that "one morning she woke up and noticed her device had moved". Over the next couple of days, she then noticed her voice no longer changed with stimulation and even tried using the magnet, but was unable to feel stimulation. Additional information was received through a company representative indicating the patient saw her treating physician and her device was working well on (b)(6) 2010. The treating nurse evaluated the patient and did not appear to be concerned with the patient's events, however, the patient was scheduled to see her treating neurologist. Further information from a company representative revealed the patient's device was fine and was scheduled to have vns repositioned.
 
Manufacturer Narrative
Date of this report, corrected data: the initial report inadvertently reported this data incorrectly. The initial aware date was (b)(6) 2010. Suspect medical device lot #, corrected data: the initial report inadvertently did not report this data. Date received by manufacturer, corrected data: the initial report inadvertently reported this data incorrectly. The initial aware date was (b)(6) 2010.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936653


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2017, 02:14:39 AM
Model Number 302-XX
Event Date 11/01/2010
Event Type  Malfunction   
Event Description
It was reported that the pt had high impedance on diagnostics. The pt stated that he could always tell the device was working because he could feel stimulation and had voice alteration with stimulation. One week before high impedance was found, the pt stated that it felt "odd" and he could not feel stimulation anymore. The pt has been sent for an x-rays of the device, but this has not been performed yet. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1940527


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2017, 09:27:20 AM
Model Number 102
Event Date 10/27/2010
Event Type  Injury   
Event Description
It was reported that the pt felt she had not had efficacy with vns and had possibly even had a slight worsening in seizures since vns was implanted. The pt has always been set to very low settings due to painful stimulation and intolerable hoarseness. The pt's device has been turned off and she may have it removed. No surgery has occurred to date. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1933757


Title: Re: Voice/Speech
Post by: dennis100 on July 09, 2017, 09:28:02 AM
Model Number 102
Event Date 07/16/2010
Event Type  Injury   
Event Description
It was reported that vns pt has been experiencing severe voice hoarseness. The pt treating neurologist believes he is suffering from vocal cord paralysis and has referred him to an ent specialist to seek therapy. The vns device diagnostics was normal during the same office visit; however, the physician attributes the vocal cord paralysis to normal stimulation of vns device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1933761



Title: Re: Voice/Speech
Post by: dennis100 on July 11, 2017, 03:34:18 AM
Model Number 302-20
Event Date 10/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer review x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient's device was showing high impedance and the patient had hoarseness since vns implant. The patient feels the stimulation. X-rays were taken and the generator was turned off. X-rays were reviewed by the manufacturer which revealed no anomalies. No manipulation or trauma occurred. Per physician, the hoarseness has not resolved since device turned off and they feel the patient has paresis of the vocal cords. The physician plans to remove the vns and not replace it as they feel it has caused damage. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1949840


Title: Re: Voice/Speech
Post by: dennis100 on July 13, 2017, 03:27:33 AM
Model Number 302-20
Event Date 10/29/2010
Event Type  Injury   
Event Description
It was reported by an epileptologist that a vns patient was still in the hospital with laryngeal paralysis. The patient had been implanted with vns on (b)(6) 2010 and at the moment was unknown if the patient had been programmed on with vns therapy. Good faith attempts to obtain additional information from the surgeon's office have been unsuccessful to date. Review of the manufacturer's in house programming history was done and concluded that the patient's parameters and diagnostics were not available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917762


Title: Re: Voice/Speech
Post by: dennis100 on July 13, 2017, 03:28:29 AM
Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported that the vns pt, who was initially implanted with the device in (b)(6) 2010, was experiencing an increase in seizure frequency, above the pre-vns baseline. The pt's caregiver indicated that the seizures have increased since the vns device was programmed on and the seizures were occurring "one after another". The treating physician had programmed the device to 0ma and the seizure frequency began to decrease. The pt was also experiencing severe hoarseness. At the pts request, the vns device was explanted. Good faith attempts to obtain additional information have been made, but no additional information has been rec'd to date. In addition, good faith attempts to obtain the explanted device for analysis are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1920074


Title: Re: Voice/Speech
Post by: dennis100 on July 16, 2017, 06:45:45 AM
Model Number 102
Event Date 11/24/2010
Event Type  Injury   
Event Description
It was initially reported that a vns pt was "experiencing an extra heart beat with stimulation", which had been occurring for the past several months. The pt's medical professional was able to verify that an extra beat appeared with stimulation from vns. The stimulation events were also correlated to the pt's transient hoarseness from the vns therapy. Further info indicated that the pt had a prior heart condition, resting sinus tachycardia; however, there had been no cardiologist work-up prior to implantation with the vns. Settings at the time of the initial report were 1 ma/15 hz/130 microsec/7 sec/1. 8 min with no current diagnostic data available. There had been no changes in medications or settings to cause the onset of the event. Furthermore, the device was not disabled to see if the symptoms went away. Further info from the pt revealed that she had a "recent cardiovascular event" where "she felt she had an extra heartbeat". It was recommended to the pt that she see a cardiologist by her treating physician. Good faith attempts to gain further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005854


Title: Re: Voice/Speech
Post by: dennis100 on July 18, 2017, 04:44:05 AM
Model Number 302-20
Event Date 12/07/2010
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
A vns treating physician reported to their country representative in the (b)(6) that they had a patient with high lead impedance on their normal mode diagnostic testing. High impedance: (b)(6) 2010, 10. 000 ohms. The patient was also having hoarseness with stimulation on time and shortness of breath with stimulation on exertion. The patient's vns has been programmed off. The patient did not have efficacy with their seizures with the vns so at this time, no revision surgery is planned. X-rays are going to be sent to the manufacturer for review. The patient plays hockey so it is possible he had a fall that may have attributed to their high lead impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2012173


Title: Re: Voice/Speech
Post by: dennis100 on July 18, 2017, 04:44:40 AM
Model Number 302-20
Event Date 11/23/2010
Event Type  Malfunction   
Event Description
On (b)(6) 2011, a vns treating physician reported to the mfr's distributor in (b)(4) that the pt was experiencing difficulty speaking. The words felt like they were stuck in his throat. The device failure disturbs him and can be painful at times. On (b)(6) 2011, the physician reported that the pt was experiencing high impedance. System diagnostics were run that day. The results showed output-limit/ output current - 1. 00ma/ lead impedance - high/ dcdc -7/ near eos- no. The pt was also experiencing an increase in seizures above pre-vns baseline level. The pt had x-rays taken on (b)(6) 2011 and they will be sent to the mfr for review. The physician stated that the pt had a fall preceding their high impedance. Surgery may be planned in the future depending on the mfr's assessment of x-ray results. If add'l info is attained, it will be reported.
 
Manufacturer Narrative
Device malfunction suspected, but did not cause a pt death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2050066


Title: Re: Voice/Speech
Post by: dennis100 on July 23, 2017, 07:17:06 AM
Model Number 101
Event Date 03/24/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received by case management. Review of clinic notes dated (b)(6) 2010 state that the pt has an occasional hoarse voice. Clinic notes dated (b)(6) 2011 state that the pt has occasional headaches. (b)(6) 2011, clinic notes say, the pt could no longer feel the throat effect of her vns and that it appears to have quit in the middle of the day. The night before, she felt tremulous inside and out and felt cognitively slow, however, the clinic notes said, she had the stomach flu. She also has a metallic taste in her mouth and in increase in seizures, unk relationship to pre-vns levels. The physician reported that there might be a possible dysfunction with the vns but that it appeared to be working that day. Good faith attempts for additional info from the physician have been to no avail thus far. If additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2086580


Title: Re: Voice/Speech
Post by: dennis100 on July 25, 2017, 04:24:17 AM
Model Number 302-20
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
It was reported by a neurologist that a vns patient had high lead impedance. The patient also alleged lack of efficacy which is likely due to vns therapy not being delivered. The treating neurologist referred the patient for a full revision. During the surgery consultation, the surgeon discovered that patient had developed a vocal cord dysfunction (vcd). The surgeon treated patient's vcd by radiesse injections to the vocal cord. Patient's vns device had been turned off and revision surgery is likely. It is unclear when vcd started and if it is related to high lead impedance. Patient had a history of voice alteration and loss of voice for 4 months after initial implantation. Good faith attempts to obtain more information regarding patient's high lead impedance and her vocal cord dysfunction have been unsuccessful to date.
 
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=2095878


Title: Re: Voice/Speech
Post by: dennis100 on July 26, 2017, 04:21:20 AM
Model Number 102
Event Date 03/15/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient had experienced vocal cord damage and/or vocal nerve damage that is sometimes worsened by vns. It was also indicated that the patient has a parafalcine meningioma. The relationship of these events to vns therapy or surgery is unknown as follow-up with the physician has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063727


Title: Re: Voice/Speech
Post by: dennis100 on July 27, 2017, 05:08:03 AM
Event Date 03/01/2011
Event Type  Injury   
Event Description
A vns programming nurse contacted our vns consultant in the (b)(6) and reported that they have a patient with voice paralysis but the nurse was not entirely convinced that it is not due to their difficult behavioral issues. The office nurse had performed a double ramp up of their settings and everything was fine but later on, the mother reported that he had a lack of voice projection. The event remained constant but resolved without intervention. The patient will not be evaluated by an ent physician. It is possible they do not have vocal cord paralysis but voice alteration from the double ramp up that resolved over time. No further information will be attained. The patient has had a 60% reduction of seizures but this coincides with a worsening of behavior resulting in expulsion from school. Although it was reported that an improvement in seizure control (forced normalization of their behavior) no known medicine change was reported prior to the event. Their behavior became progressively worse after implantation with the vns. No interventions were taken for this. No further information will be provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2055650


Title: Re: Voice/Speech
Post by: dennis100 on July 27, 2017, 05:09:05 AM
Model Number 304-20
Event Date 01/27/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns patient had become non-verbal. According to the treating neurologist, the patient typically makes noises but has failed to do so since initial vns implant on (b)(6) 2011. The neurologist believes that patient has vocal cord paralysis due to vns surgery; thus, he did not turn on the vns device and referred the patient to an ent specialist. Patient does not have a medical history of the aforementioned event.
 
Manufacturer Narrative
The patient's adverse event is related to the implant procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2052589


Title: Re: Voice/Speech
Post by: dennis100 on July 29, 2017, 12:56:23 AM
Model Number 03
Event Date 03/31/2011
Event Type  Injury   
Event Description
A vns programming nurse in the (b)(6) reported to our consultant that they had a pt in a pulse2 study and he complained of his epilepsy worsening (no longer receives warning that the seizure is about to occur), hoarseness with the regular stimulation and breathlessness on exertion. He requested that his vns be programmed off. Their voice alteration and breathlessness on exertion were related to the regular stimulation. The cause of their seizures was unk. Pulse width and signal frequency were lowered at one point but device was disabled on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115162


Title: Re: Voice/Speech
Post by: dennis100 on July 29, 2017, 01:30:22 PM
Model Number 103
Event Date 03/24/2011
Event Type  Injury   
Event Description
It was initially reported that pt had been having issues with hoarseness since the time of implant. However, during follow-up with the physician, the nurse said that the pt had gone into asystole during both intraoperative system diagnostic tests. Both tests were within normal limits (no specifics available). The electrode placement was not altered after this experience in the surgery since all diagnostic testing was normal. It was unk if the pt had stimulation enabled since the implant's time. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096056


Title: Re: Voice/Speech
Post by: dennis100 on July 30, 2017, 12:30:13 AM
Model Number 103
Event Date 03/23/2011
Event Type  Injury   
Event Description
It was reported by a vns physician that he believed the vns pt to have partial vocal cord paralysis. The pt had been recently implanted and her output current had been enabled. The pt reportedly had difficulty speaking since implant, which is a constant phenomenon. Further information was obtained from the physician. On (b)(6) 2011, system diagnostics resulted in ok's, impedance = 3827 ohms, and ifi=no. It was noted that the pt's voice was hoarse on this day. Furthermore, the settings at this time were stated to be 0. 25/20/250/30/5 and 0. 25/60/500. The physician stated that stimulation up to 1ma did not evoke a change in the pt's voice or a cough. The physician stated he would maintain the pt's low settings and discuss the details with the manufacturer. Good faith attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2093643


Title: Re: Voice/Speech
Post by: dennis100 on July 30, 2017, 04:58:32 AM
Model Number 304-20
Event Date 08/26/2010
Event Type  Injury   
Event Description
It was initially reported that the pt has been experiencing constant voice hoarseness since surgery. The hoarseness is not associated with stimulation and diagnostics are within normal range. The pt physician consulted an ent colleague and he felts it may be a vocal cord paralysis. There is no intervention that is planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092596


Title: Re: Voice/Speech
Post by: dennis100 on July 30, 2017, 04:59:18 AM
Model Number 101
Event Date 04/07/2011
Event Type  Injury   
Event Description
It was reported by a patient's guardian that the patient had hoarseness that had increased over the past year. He was also complaining of shortness of breath and a shocking feeling. The patient had been to see an ent physician who performed a laryngeal scope, which found the left vocal cord to be exhibiting paresis. Follow-up from the patient's physician's office was attempted, but the office stated they understood that the battery was "bad" and needed to be changed. No further information could be provided. The local company representative stated the patient had been scheduled for a prophylactic battery replacement as the patient could no longer feel the vns stimulation regularly- the patient felt the stimulation irregularly, leading to the report of being shocked. Furthermore, the hoarseness and shortness of breath were stated to be pre-existing conditions. The patient and caregiver stated the vns had been helpful and they "very much wanted" the generator replacement. Good faith attempts for further information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2088568


Title: Re: Voice/Speech
Post by: dennis100 on July 30, 2017, 09:42:45 AM
Model Number 304-20
Event Date 02/16/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, it was reported by the vns pt that he was implanted on (b)(6) 2011 and hasn't been able to talk since; his voice was very raspy. His vns has not been turned on. The pt was referred to an ent physician to determine if there was vocal cord paralysis. The neurologist feels that this could be due to the surgical technique since the surgery was said to have taken about 1. 5 hours. On (b)(6) 2011, the pt reported that they still had no voice and could talk only in a whisper. The surgeon believes the damage was done when he was intubated prior to surgery. The physician reported on (b)(6) 2011 that the ent did find that the pt has vocal cord paralysis due to device placement. The paralysis does not occur with stimulation. The ent is going to inject the vocal cords. The pt's device remains disabled at this time. If add'l info is rec'd, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082894


Title: Re: Voice/Speech
Post by: dennis100 on July 31, 2017, 07:52:50 AM
Model Number 103
Event Date 05/04/2011
Event Type  Injury   
Event Description
On (b)(6), 2011, a vns surgeon's nurse reported that the vns patient is scheduled for a vns revision surgery in (b)(6) 2011. The patient's physician reported that the patient had an altercation with her boyfriend soon after implant surgery, dislodging the generator. The patient had previously been complaining of breathing difficulty and voice alteration with stimulation. The physician said that he was going to do some programming adjustments to alleviate the patient's breathing difficulties and voice alteration. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2148838


Title: Re: Voice/Speech
Post by: dennis100 on August 02, 2017, 12:32:20 AM
Event Date 06/01/2011
Event Type  Malfunction   
Event Description
It was reported by a nurse through a company rep that a recently implanted vns pt experienced hoarseness and became breathless. The event occurred after the pt was programmed on after surgery in the recovery area. Diagnostics were performed on the device and they were indicative of high lead impedance (10,000 ohms). The device was programmed off and the pt was referred for x-rays. X-rays were reviewed by the treating surgeon who indicated all was well with the lead and generator. Further info was received from the pt's caretaker who indicated that the pt remained hoarse and breathless. At the moment, good faith attempts to obtain add'l info have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, 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=2191857


Title: Re: Voice/Speech
Post by: dennis100 on August 02, 2017, 12:32:54 AM
Model Number 102
Event Date 01/24/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns pt was having increase in seizures, voice hoarseness, and aspiration. On (b)(6) 2011, the neurologist referred the pt for generator replacement since it was near end of service. The generator was received by the mfr and currently is undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2190784


Title: Re: Voice/Speech
Post by: dennis100 on August 02, 2017, 12:33:32 AM
Model Number 302-20
Event Date 02/01/2011
Event Type  Malfunction   
Event Description
It was initially reported that the pt was complaining of tightening and intermittent pain in her neck and throat into her left ear. The pain was described as burning and jolting and not occurring with stimulation. X-rays were received and reviewed. Generator placement appeared normal and there were no lead discontinuities or sharp angles observed in the visible portions of the lead boy, however, a fracture or micro-fracture cannot be ruled out. Additional info was received indicating that the pt's was also experiencing hoarseness, choking, shooting pain through left ear, and breathing problems. No trauma was suspected, however, it was noted that the pt was moving and had been lifting heavy boxes. Diagnostics could not be performed because the pt could not tolerate the side effects as her output current was less than 1ma. The pt was scheduled for, and underwent a full revision surgery. During the revision surgery, it was noted that the lead insulation appeared to be frayed near the generator. Diagnostics could not be performed prior to the lead explant. The device has since been returned. However, product analysis is not yet complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2191333


Title: Re: Voice/Speech
Post by: dennis100 on August 02, 2017, 12:34:09 AM
Event Date 06/30/2011
Event Type  Malfunction   
Event Description
It was reported by a neurologist via clinic notes that a vns pt had more frequent seizures and had voice hoarseness with vns stimulation. Pt's generator was implanted in 2000 and her symptoms have improved. The pt has not had any grand mal seizures for about one year; however, she continues to have 2 to 3 complex partial seizures per month, but the intensity is much lower than pre-vns. Pt's post-ictal period is shorter and lasts about 30 minutes and magnet swipe helps her with the seizures and whenever she has auras. During the most recent office visit, the neurologist noticed that pt's generator setting was zero and she adjusted her settings to 0. 5ma. Currently, it is unk why the setting was set to zero.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2191337


Title: Re: Voice/Speech
Post by: dennis100 on August 02, 2017, 12:34:54 AM
Model Number 304-20
Event Date 07/08/2011
Event Type  Injury   
Event Description
It was reported by an ent surgeon that a vns pt was having dyspnea, paresis, and voice alteration. The voice alteration and paresis were occurring with vns stimulation and pt's vocal cords would get immobilized. However, her vocal cords would return to normal function after vns stimulation stopped. Additionally, the physician stated that at times, the pt's vocal cords get constricted so severely during the on times that it cuts off her breathing. This condition gets worse during exercise for pt. Pt has been having a great seizure control with vns therapy and would like to keep the vns turned on. The pt's generator's diagnostics were within normal limits on (b)(4) 2011. During (b)(4) 2011, pt complained that her throat was bothering her but did not want the setting lowered. During the next appointment on (b)(4) 2011, pt's settings, pulse width and frequency were lowered and pt's pain was resolved. Mfr received and reviewed the x-rays. The alignment of the positive and negative electrodes appeared to be normal. The lead was routed towards the generator. The generator was placed on the left chest and a small amount of lead was placed behind the generator. The connector pin could not be assessed since the generator was only partially visible in the x-ray images. However, the filter feed-thru wires appeared to be intact. Based on the x-ray images received, no obvious anomalies could be identified in visualized portion of the pt's vns device.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2192435


Title: Re: Voice/Speech
Post by: dennis100 on August 02, 2017, 12:35:31 AM
Model Number 102
Event Date 07/06/2011
Event Type  Malfunction   
Event Description
Patient who had vagal nerve stimulator implanted ~3 years ago (pt had history of intractable epilepsy). He subsequently moved to out of state and reports establishing care at a neurology practice, and a physician there changed settings as the device was affecting his voice. After that time, he began to have difficulties which retrospectively he feels were related to his device. He was an avid runner, and would experience shortness of breath when he would run after about 5 minutes, and would then improve after he would stop for a few minutes. At the time he attributed it to the change of climate. He eventually developed severe shortness of breath and it was found that his stimulator was misfiring causing constriction of the vocal cords. After that time, the device was turned off and it subsequently has been off ever since. The patient returned for removal of the stimulator. The lead remains in the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2192706


Title: Re: Voice/Speech
Post by: dennis100 on August 03, 2017, 07:36:25 AM
Model Number 300-20
Event Date 10/13/2010
Event Type  Injury   
Event Description
It was initially reported following explant surgery that the patient was having vocal cord issues and trouble swallowing. The patient is currently not implanted with any vns devices. The patient saw an ent physician and received a micro dl. The patient is now doing well was swallowing food but is still having problems with liquids. The patient has not had their vns devices replaced at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2161854


Title: Re: Voice/Speech
Post by: dennis100 on August 03, 2017, 07:36:59 AM
Event Date 06/10/2011
Event Type  Injury   
Event Description
It was reported that the pt was having increased seizures, relationship to pre-vns levels unk. The pt was also having some metal deterioration and trouble finding words. The pt has not been seen by a physician in several years, but her new physician will refer her for generator replacement due to suspected end of service. The pt underwent generator replacement on (b)(6) 2011. Attempts for further info and product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2161857


Title: Re: Voice/Speech
Post by: dennis100 on August 04, 2017, 03:22:31 AM
Event Date 01/02/2017
Event Type  Injury   
Event Description
An article was received that reported multiple adverse events and a malfunction. The current report captures the adverse events associated with the generator. Mfr. Report # 1644487-2017-04155 captures the malfunctions reported by the article. Mfr. Report # 1644487-2017-04154 captures adverse events associated with the lead. There was one intraoperative adverse event associated with the generator. This patient experienced transient asystole intraoperatively. This event resolved without treatment and did not require cardiopulmonary resuscitation. There were three reported post-surgical complications related to the generator. There was one patient that presented with wound dehiscence one week post-surgery that was managed surgically. Another patient presented with an infection at both generator and neck sites; this patient had full recovery after being treated aggressively, first with iv antibiotics for one week and second with oral antibiotics for another week. The last patient experienced post-operative status epilepticus that required 3 days intubation and icu admission; this was most probably related to general anesthesia used during surgery. The article reported that 10 patients experienced laryngeal side effects associated with stimulation (coughing, hoarseness and shortness of breath) that were proportional to amplitude, frequency and duration of stimulation. These patients all presented with a significant increase in vocal handicap index. These patients were found to have decreased left cord mobility that was more significant with vocal cord abduction. The left cord in the resting position was shorter and more medially-positioned than the right vocal cord. None had complete vocal cord paralysis and their voice changes did not affect their ability to communicate and shortness of breath was mild. None needed medical or surgical treatment. Vocal hoarseness resolved in patient's no longer receiving therapy. One patient experienced an increase in seizures with vns therapy. The patient' caregivers requested vns removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6723189


Title: Re: Voice/Speech
Post by: dennis100 on August 04, 2017, 03:23:04 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/29/2016
Event Type  Injury   
Event Description
Clinic notes reported that a patient was experiencing difficulty breathing, throat tightness, and hyperventilation. The patient and physician were initially unsure if the symptoms were related to vns. The physician later reported that the patient experienced voice alteration and throat tightness when her device output current was increased, believing that the voice alteration and throat tightness were related to vns. The physician increased the frequency to resolve the patient's voice alteration and throat tightness. Additionally, the physician decreased the patient's vns off time while maintaining the same vns output current, vns on time, and medication schedule to help with the voice alteration and throat tightness. The physician reported that the intervention taken was required to preclude a serious injury. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727261


Title: Re: Voice/Speech
Post by: dennis100 on August 04, 2017, 03:23:59 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 11/22/2016
Event Type  Injury   
Event Description
It was reported that following the vns generator replacement, the patient appeared fine after the surgery. However, shortly after the surgery, the patient had labored and heaving breathing with excessive coughing spells. It was reported that the patient was experiencing a raspier voice than normal. The symptoms were reported as happening all of the time and not just with stimulation. The patient had stated that he did not have these symptoms with the previous generator. There were no concerns from the physician during or after the surgery and the patient has not reported any seizures. A surgeon who was not involved with the implantation stated that the patient vocal cord paralysis, but the implanting surgeon had disagreed. It appears that the prior to surgery the patient's vns normal mode stimulation was programmed off for an undetermined amount of time. The patient was programmed back to therapeutic levels post-op without titration. Follow up with the implanting surgeon revealed that the surgeon who stated that there was vocal cord paralysis performed his test in the month of implantation. The implanting surgeon stated that the other surgeon had no prior experience with vns placement and that no change of leads had been performed during the replacement surgery. The implanting surgeon performed the same test half a year later and the results showed that the patient had mild paresis of the left vocal fold.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727766


Title: Re: Voice/Speech
Post by: dennis100 on August 04, 2017, 05:55:59 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 06/13/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient had a recent increase in seizures and the physician was not sure if it was related to vns or not. A chest x-ray was performed and looked ok and no low battery indicator was present. The physician did not notice a change in her voice at all. An estimate of battery life using the manufacturer¿s in-house programming history database predicted 0. 9 years until low battery condition. Notes received from a visit on (b)(6) 2017 state the patient does think she can feel her vns going off. The patient continues to have poorly controlled seizures. The reason for the recent exacerbation of seizures is not clear. The physician stated in the notes it is possible, given the age of the device, it is failing and near end of life cycle and needs to be replaced. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6706156


Title: Re: Voice/Speech
Post by: dennis100 on August 04, 2017, 07:59:30 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/10/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient wanted her vns removed because she didn't like it. Follow up with the physician's office revealed that the patient was experiencing voice alterations and that this was the reason the patient wanted the device explanted. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6691023


Title: Re: Voice/Speech
Post by: dennis100 on August 04, 2017, 08:00:03 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 06/22/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient was experiencing painful stimulation. The physician first wanted to lower the output settings, but was trying not to have major surgery. It was later provided that the patient was scheduled for a full revision due to painful stimulation and voice alteration. Full revision surgery occurred. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6730458


Title: Re: Voice/Speech
Post by: dennis100 on August 05, 2017, 12:16:09 AM
Model Number 102
Event Date 04/01/2011
Event Type  Injury   
Event Description
It was reported by the patient that she believes her vns generator has reached end of service. She has not seen her neurologist since (b)(6) 2009 because the physician is no longer part of her hmo. The patient believes her generator is dead because she no longer experiences voice alteration and she feels that her depression has been worsening for the last 6 months. Additional information was later received indicates that she has seen a new neurologist and being referred for vns generator replacement. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155944


Title: Re: Voice/Speech
Post by: dennis100 on August 06, 2017, 01:26:37 AM
Model Number 304-20
Event Date 06/21/2011
Event Type  Injury   
Event Description
It was reported that the patient was experiencing persistent neck pain, coughing, and dysphagia. The patient is also experiencing constant voice hoarseness that is not associated with vns stimulation. The patient reportedly went to the emergency room because she coughed so much that she ruptured a blood vessel in her lungs and she was coughing up blood. The vns stimulation was disabled for a while however the adverse events did not change. The patient wanted to keep her vns on to help with seizure control. Vns system diagnostics are normal. It was also noted that the patient has lost (b)(6) due to the dysphagia. The patient is taking pain medication to help with pain at the neck site. Follow-up with the site found that the patient is being referred to a gi specialist for further evaluation. The patient is no longer coughing up blood and the pain is tolerable with medication however the physician is concerned about the choking, difficulty swallowing, and the weight loss. The patient has also been referred back to the surgeon for possible repositioning of the leads. The surgeon has ordered x-rays to check for any issues with the vns leads.
 
Event Description
The x-rays taken by the physician have been received and reviewed by the manufacturer. No anomalies could be visualized to account for the adverse events. The patient has reportedly had no issues since having her vns re-secured due to migration as noted in manufacturer report # 1644487-2011-02470.
 
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=2229166


Title: Re: Voice/Speech
Post by: dennis100 on August 06, 2017, 01:27:17 AM
Model Number 103
Event Date 04/01/2011
Event Type  Injury   
Event Description
A report was received from the physician who was reviewing a case in regards to a lawsuit against the va hospital. He stated that the patient had experienced hoarseness and 5 second bradycardic episodes that appeared to be associated with stimulation as seen on a halter monitor. The patient then had his stimulator removed in (b)(6) 2011 due to the bradycardia and because the patient needed to have an mri. Attempts for further information have been unsuccessful to date.
 
Event Description
Attempts for the return of the explanted vns lead and generator have been made however the implant hospital stated that they are not sure what would have happened to the explants as the physician is no longer at their hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2236563


Title: Re: Voice/Speech
Post by: dennis100 on August 07, 2017, 03:22:33 AM
Model Number 302-20
Device Problems Corrosion; Fracture
Event Date 05/01/2011
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery due to lead discontinuity on (b)(6) 2014. Attempts to have the product returned for analysis were made but were unsuccessful.
 
Event Description
Attempts for additional information have been made to both the patient's treating neurologist and surgeon, and no information has been made available by either site.
 
Event Description
Product analysis of the returned generator was completed. Visual analysis showed only observations consistent with the explant procedure; no surface abnormalities were noted on this device. The pulse generator communicated normally and the eri flag was not set. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found.
 
Event Description
It was reported that a patient was experiencing pain in his neck and had lost his voice. Diagnostics performed on the patient's generator showed high impedance with a dc/dc of 7. The generator was programmed to 0ma and the patient was sent for x-rays. It is unclear if the x-rays will be sent to the manufacturer for review. The patient has been scheduled to see an ent and has been referred for surgery. Surgery is likely, but has not occurred to date.
 
Event Description
Additional information was received that the patient would have the device explanted and go for a surgical work-up. The nurse indicated that the patient is not likely a surgical candidate, so will have a new vns implanted at a later date. No additional information was provided. Surgery is likely, but has not occurred to date.
 
Event Description
Additional information was received indicating that the patient has declined replacement. His device has since been disabled. Attempts for additional information have been unsuccessful to date.
 
Event Description
The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned portions of the explanted lead. During the visual analysis of a returned 3. 5mm portion of the negative green electrode, it was observed that the coil portion of this segment was not present. What appeared to be a greenish tint was observed inside the inner silicone tubing. This was an indication the coil had most likely dissolved and became detached from the ribbon at one point in time. Stimulation was present for a certain period of time as evidenced by the presence of greenish tint inside the inner silicone tubing. Based on the findings, there was evidence to suggest a discontinuity in the returned portions of the device. With the exception of the discontinuity, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed and no other discontinuities were identified. The set screw marks found on the lead connector pin provided evidence that, at one point in time, a good mechanical and electrical connection was present. The returned generator is undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229120


Title: Re: Voice/Speech
Post by: dennis100 on August 07, 2017, 03:23:09 AM
Model Number 102
Event Date 07/09/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt had increase in seizures. Pt had been seizure free for the past 6 months but suffered a grandmal seizure on (b)(6) 2011 where he fell and hit his head to the tv. Paramedics were called but the pt was not taken to the emergency room. The pt had missed one does of medication, topamax, at night. Since then, pt has had several seizures, auras, been dazed/consufed, and couldn't talk or repeat words. Subsequently, pt was referred for prophylactic surgery which was completed on (b)(6) 2011. The explanted device was returned to the mfr on (b)(6) 2011 and it is undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229492


Title: Re: Voice/Speech
Post by: dennis100 on August 08, 2017, 02:12:00 AM
Model Number 103
Event Date 07/13/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012, when analysis of the explanted lead was completed. Note that since a portion of the lead (including) the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above typical wear and explant related observations, no anomalies were identified in the returned lead portion. The analysis of the generator was completed on (b)(4) 2012. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient's lead and generator were explanted and not replaced on (b)(6) 2012. Follow up with the site revealed that the device was removed due to lack of efficacy and they did not have any additional information to provide. The lead and generator were received by the manufacturer on (b)(4) 2012 and are currently undergoing product analysis.
 
Event Description
On (b)(6) 2011, a vns treating nurse practitioner reported that the vns patient was in the hospital due to seizures. The patient's parent is concerned because when they tape the magnet over the device during meal time recently to halt voice alteration, the device still provides stimulation. In order to double check this report, the nurse practitioner taped the magnet over the device that day in the hospital for about 20 minutes and the device was still activating while the magnet was in place. System diagnostics and normal mode diagnostics were performed on the generator and results were normal; impedance value of 2621ohms and 2635ohms respectively. The device was interrogated and the magnet activations were examined. The handheld showed that the device recorded multiple magnet activations while the magnet was in place for about 20 minutes. The manufacturer's consultant reported that the magnet was taped securely to the skin and the generator is able to be visualized under the skin. The patient was implanted recently in (b)(6) 2011, so the magnet is fairly new. The nurse practitioner stated that she did not know if there was any trauma to the site. The generator is currently disabled due to the magnet issue and the most recent settings before it was disabled were output=1. 5ma/frequency=20hz/pulse width=250usec/on time=21sec/off time=3min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The nurse practitioner reported later that the patient falls a lot but the parents don't know if he fell on the generator directly. His impedance checked out normally for both system and normal mode diagnostics. The patient's brother did bite him near the generator but did not break the skin. He aspirates during stimulation, so they now have the generator off. The patient has had aspiration pneumonia for a while now, so the magnet was being used to disable the device while eating. The nurse did not know if the patient has a history of aspiration, but did state that they have questioned whether or not the vns has made the aspiration worse. Lately (time frame unknown), the mother has noticed that the magnet is not working as it did to disable the device. The nurse states that the magnet had been helping at one point, though, and had improved the patient's aspiration. She stated that the patient has had worsening focal status and that the mother reports that the vns has not helped. The nurse stated that the generator protrudes from the chest so she is sure that the magnet is properly taped over the device. The patient's mother has tried both magnets that came with the patient kit but neither will work lately and it is unknown which side is being taped facing the generator. The nurse reported that she does not know where the magnets are stored when they are not in use. The nurse then stated that during the 20 minutes that the magnet was taped over the device, the patient experienced voice alteration 3 different times for about 60 seconds (magnet on time is 60 seconds). After the device was disabled, no voice alteration was observed. The physician's nurse reported that they tried new magnets and they also did not work to disable the device. Therefore, the patient's generator is programmed to 0ma at this time. The patient has progressively worsening epilepsy and they do not think that it is related in any way to vns. They did not think the vns was helping even before it malfunctioned. If additional information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2200870



Title: Re: Voice/Speech
Post by: dennis100 on August 09, 2017, 05:56:28 AM
Model Number 103
Event Date 06/18/2011
Event Type  Injury   
Event Description
Reporter indicated that a recently implanted vns patient had developed vocal cord paresis, increased secretions, hiccups, vomiting, and a low-grade fever. Further follow up revealed, the patient had developed aspiration pneumonia and aphonia. The patient was hospitalized and had a videostroboscopy which showed left vocal cord paresis with slight movement. The vns has been disabled to allow for healing. The patient may have collagen injections for the vocal cord paresis. The cause of the patient's issues are felt to be likely related to the vns implant surgery. The hiccups have resolved and the aspiration pneumonia is clearing following antibiotic treatment. The patient has also been able to speak a little. The patient is not on supplemental oxygen. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193837


Title: Re: Voice/Speech
Post by: dennis100 on August 10, 2017, 07:42:23 AM
Model Number 302-20
Event Date 09/30/2011
Event Type  Malfunction   
Event Description
It was initially reported that the patient claims that he has suffered a disability due to vns implantation and adverse events. Follow-up was done with his treating physician's office. The nurse was unaware of any disability of that the patient was having. The physician was out of town and unable to comment on that the patient was referring to. The office said that all adverse events that the patient experienced was reported the manufacturer as part of a clinical study. Review of the history the manufacturer had on the patient indicated that the patient had coughing and voice alterations following implant surgery which was believed to be related to implant. It is unknown if that was what was meant by the patient as a disability.
 
Manufacturer Narrative

Manufacturer Narrative
Manufacturing records were reviewed. Review of the device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient did have their generator disabled.
 
Event Description
Additional information was received indicating that the vns patient device was disabled on (b)(6) 2011.
 
Event Description
Review of the patient's available programming history available in the in-house database revealed that on (b)(6) 2011, system diagnostics were within normal limits, but that the dc-dc converter code value had dropped to 0. Previously on (b)(6) 2010, the system diagnostics results were within normal limits with dc-dc converter code value of 3. A significant decrease in dc-dc converter code value on the system diagnostics (e. G. , ¿3¿ to ¿0¿) from prior system diagnostics may indicate a lead problem. The patient previously reported that the reason the device was disabled on (b)(6) 2011 was due to the belief that vns therapy did not help him. The physician did not provide any further information on the patient's symptoms.
 
Event Description
Additional information that was received that indicated that the "disability" that was reported was just that the patient had voice alteration. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2262572


Title: Re: Voice/Speech
Post by: dennis100 on August 12, 2017, 06:50:39 AM
Model Number 103
Event Date 07/15/2011
Event Type  Injury   
Event Description
Additional information was received on december 8, 2011 when the physician reported that the relationship of the increase in seizures to vns is unclear. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. The patient's settings prior to battery replacement were listed as output=3. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=3. 5ma/magnet on time=60sec/magnet pulse width=500usec/eri=yes on (b)(6) 2011. The physician also provided clinic notes dated (b)(6) 2011 that state the patient was doing well in terms of seizures and that his last seizures as about a year ago. After battery replacement, the patient was programmed back up to output=3. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=3. 5ma/magnet on time=60sec/magnet pulse width=500usec during her follow up visit on (b)(6) 2011.
 
Event Description
Attempts for the return of the patient's explanted generator for product analysis have been made, but the explanted product has not been received by the manufacturer. The patient's programming history was reviewed and on (b)(6) 2010 the patient's generator showed 5 months left till end of service.
 
Event Description
It was initially reported that the patient's generator was showing that it was near end of life. Later, the patient's mother stated the patient had experienced an increase in seizures, and now how voice changes with stimulation were not as intense, indicating the battery may be failing. The patient was sent for replacement surgery, where the near end of service indicator was seen; the battery was still supplying output current at this time. The patient's last known diagnostics showed the device to be properly functioning. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2257002


Title: Re: Voice/Speech
Post by: dennis100 on August 12, 2017, 06:51:21 AM
Model Number 102
Event Date 08/24/2011
Event Type  Injury   
Event Description
It was reported that the patient had her generator and leads replaced as she had hoarseness and discomfort whenever the physician would attempt to increase her settings. The leads were replaced prophylactically in this case in an attempt to mitigate the side effects. There had been no reported trauma to the patient, and diagnostics prior to surgery were said to be within normal limits. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2257003


Title: Re: Voice/Speech
Post by: dennis100 on August 14, 2017, 02:59:29 AM
Model Number 303-20
Event Date 07/01/2011
Event Type  Injury   
Event Description
It was reported that the pt has post-operative vocal cord paralysis. Attempts for additional info have been unsuccessful to date.
 
Event Description
Additional information was received from the surgeon. The vocal cord paralysis was initially identified as the patient had hoarseness. The paralysis is believed to be related to vns surgery, and is not occurring with stimulation. The left vocal cord is paralyzed. The patient is being seen by and ent and is continuing speech therapy. The patient does not have a history of vocal cord paralysis prior to vns, however the patient does have a history of dysphonia following a previous stroke. Per the ent evaluation the vocal cord is at 60%. The ent has recommended a swallow study.
 
Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: follow-up report #01 inadvertently did not include the provided diagnostics and programmed settings for the patient on the day of implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2251349


Title: Re: Voice/Speech
Post by: dennis100 on August 16, 2017, 04:14:19 AM
Model Number 102R
Event Date 10/06/2011
Event Type  Malfunction   
Event Description
Product analysis of the explanted generator has been completed and it was found to be at end of service as the result of normal expected battery depletion. The generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the generator. Attempts are still being made to obtain device diagnostics post generator replacement to determine the cause of the high lead impedance that was reported.
 
Event Description
Additional information was received including post-operative diagnostics which indicates that there was no issue with the implanted lead. When attempting to verify with the neurologist and surgeon as to whether or not high lead impedance readings were actually obtained and when, neither physician could provide the dates or results however if it was obtained, it was most likely due to normal depletion of the battery found within the generator.
 
Event Description
Additional information was received on (b)(6) 2011, when it was reported that the patient's treating neurologist is leaving the practice and multiple calls to his office to obtain additional information were unsuccessful. As the physician is leaving the practice, no further information can be obtained from him regarding the patient's events. The patient underwent surgery on (b)(6) 2011, where only the generator was explanted and replaced. During surgery, pre-operative systems and normal mode diagnostics were performed which resulted in ok/ok/2/yes. Diagnostics post replacement were not provided. The explanted generator has been returned to the manufacturer and analysis is currently underway.
 
Manufacturer Narrative
Brand name, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. Type of device, name, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. Model #, serial #, lot #, expiration date, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. If implanted, give date: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. If explanted, give date: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. Device available for evaluation? if yes, returned to manufacturer, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. Device evaluated by mfr, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. Device manufacture date, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report. Method, results, conclusion, corrected data: previous reports provided the information for the lead however additional information received indicates the issue was due to the generator therefore the information has been corrected on this report.
 
Event Description
It was initially reported that a patient did not believe her vns device was working because she was having an increase in seizure activity. The patient was still experiencing voice alteration with stimulation. Additional information received at a later date revealed that the patient was going to be referred for full revision surgery due to high lead impedance readings obtained during device diagnostics. It is unknown the exact date these results were obtained. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming/device diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2315370


Title: Re: Voice/Speech
Post by: dennis100 on August 16, 2017, 04:15:08 AM
Model Number 105
Event Date 07/22/2016
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received that the patient's vns device was turned off on (b)(6) 2016 and that the patient was not receiving vns therapy at the time of status epilepticus. It is unknown if patient had experienced status epilepticus prior to receiving vns therapy. Per the neurologist, the status epilepticus is not related to vns therapy. Additional relevant information has not been received.

Event Description
Additional information was received that the patient's device was turned back on, on (b)(6) 2016. Patient is doing very well with the device. The temporary disablement was reported to be due to patient's voice hoarseness with vns stimulation. Patient's current settings are as follows: 0. 25ma/20hz/250usec/7sec/0. 3 min/ 0. 50 ma. Diagnostic data was requested but not available.

Event Description
It was reported that the patient experienced status epilepticus and is hospitalized. It is suspected that the vns device might be off. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5880942


Title: Re: Voice/Speech
Post by: dennis100 on August 19, 2017, 02:45:02 AM
Event Date 09/27/2011
Event Type  Injury   
Event Description
Reporter indicated via a physician's internet website that an unknown number of vns patients had experienced pharyngeal paresthesias, voice alteration, coughing, dyspnea, and vocal cord paralysis which required explant of the vns. The reporter did indicate that the number of patients was a small portion. Attempts for further information were unsuccessful, as the reporter could not recall specifics on the cases, or when the events occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2296638


Title: Re: Voice/Speech
Post by: dennis100 on August 19, 2017, 02:45:43 AM
Event Date 09/27/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated via a physician's internet website that a vns patient had experienced late-onset hoarseness that was not related to vns stimulation. The patient's operative scars suggested more extensive surgical dissection during implantation of the vns. The reporter was not the vns implanting surgeon. Attempts for further information were unsuccessful, as the reporter could not recall specifics on the case, or when this occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2296605


Title: Re: Voice/Speech
Post by: dennis100 on August 20, 2017, 07:47:04 AM
Model Number 302-20
Event Date 09/06/2011
Event Type  Malfunction   
Event Description
It was reported by a nurse that high lead impedance was observed during a follow-up visit (7/limit/high). The pt's mother indicated that the voice change was no longer preset when the device activated and high lead impedance was received during diagnostics. The perception of stimulation decreased as well with the finding of high impedance. The pt had trauma to the chest area in jan in which the pt claimed the generator stimulated continuously. Diagnostics after the reported trauma were within normal limits indicating proper device function (normal mode ok/ok/4). X-rays were received by the mfr and reviewed. Review of x-rays indicated the generator was visualized in the left chest. The filter feedthrough wires were intact and the lead pin was fully inserted passed the connector blocks. There was a small portion of the lead behind the generator and continuity in that portion of the lead cannot be assessed. The electrode placement appeared to be normal and the lead was routed down to the generator. The lead appeared to be detached from the negative electrode. There were no other gross discontinuities or acute angles found in the visible portions of the lead body.
 
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=2281445


Title: Re: Voice/Speech
Post by: dennis100 on August 20, 2017, 07:47:43 AM
Event Date 09/07/2011
Event Type  Malfunction   
Event Description
It was reported that the patient's device was explanted on (b)(6) 2011, as the patient did not feel the vns had been efficacious enough for her. Per reporter, the surgeon was unable to interrogate the device during surgery as well. The explanted device was discarded and cannot be returned to the manufacturer for analysis.
 
Manufacturer Narrative

Event Description
It was reported that the physician was unable to interrogate the patient's generator. The physician has successfully used the same programming system on another patient. Physician reports that the device seems to be working as the patient still experiencing voice alteration with stimulation. Physician also reports that the patient has gained a fair amount of weight, so this might be the reason the generator cannot be communicated with as there may be more tissue between the generator and wand. Patient was seen by a surgeon and device still could not be interrogated. The patient opted to have the device removed, but surgery has occurred to date due to possible insurance coverage issues. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2275238


Title: Re: Voice/Speech
Post by: dennis100 on August 20, 2017, 07:48:21 AM
Model Number 302-20
Device Problem No Information
Event Date 07/20/2004
Event Type  Injury   
Event Description
Additional manufacturer follow-up with the treating surgeon revealed the patient does have true left vocal cord paresis, not paralysis. The right vocal cord does help compensate for the left vocal cord. The paresis is felt to be likely related to the vns implant surgery. No interventions are planned. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect patient age. Date of event, corrected data: the initial report inadvertently reported the incorrect event date.
 
Event Description
Reporter indicated a vns patient had permanent vocal cord paralysis. The patient did have recent neck surgery unrelated to the vns, and the treating surgeon did document voice hoarseness during vns stimulation prior to the surgery, but not vocal cord paralysis. Attempts to the patient's treating vns neurologist for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2284499


Title: Re: Voice/Speech
Post by: dennis100 on August 20, 2017, 07:49:01 AM
Model Number 103
Event Date 01/01/2011
Event Type  Injury   
Event Description
Product analysis on the generator was completed on (b)(6) 2011. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Attempts for additional information have remained unsuccessful.
 
Event Description
The explanted products were returned to the manufacturer on 11/09/2011. Product analysis on the explanted lead has been completed; however, analysis on the generator is still underway. An analysis was performed on the returned lead portions. 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 which may have contributed to the stated complaints. Attempts for additional information have remained unsuccessful.
 
Event Description
A pt reported that she had been experiencing a constant pain in her ear for many months. Approx one month later, the pt underwent a full revision surgery. The surgeon reported that the pt had good seizure control with vns, but stated that she had experienced side effects including coughing, voice alteration, and dysphagia. No further info regarding the pt's symptoms is available to date.
 
Manufacturer Narrative
Expiration date: initial report inadvertently listed the incorrect expiration date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2298166


Title: Re: Voice/Speech
Post by: dennis100 on August 20, 2017, 07:49:39 AM
Model Number 300-20
Event Date 02/04/2003
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2011, a vns treating physician reported that the patient has chronic hoarseness ever since the vns was implanted. The physician stated that it was probably due to recurrent laryngeal nerve damage. The patient's programming history was reviewed and a battery life calculation was performed which revealed 2. 58 years until eri = yes. The patient was last programmed to output=1. 75ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=2ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. Additional information was requested from the patient's physician but no further information was received to date.
 
Event Description
Additional information was received on (b)(4) 2012 when the physician reported that the hoarseness was possibly first observed after vns implant surgery in 2003. The physician stated that the surgery was done at an outside hospital by an ent surgeon and the physician. It was unknown if the nerve damage occurred during or after an mri according to the physician. It was unknown if any causal or contributory programming or medication changes preceded the onset of the hoarseness. The hoarseness is constant and does not occur with stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2285408


Title: Re: Voice/Speech
Post by: dennis100 on August 20, 2017, 07:50:15 AM
Model Number 304-20
Device Problem No Information
Event Date 08/11/2011
Event Type  Injury   
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect event date.
 
Event Description
It was reported by a company representative that a patient experienced severe cough and a left sided paresis of the neck along with being very hoarse after the patient underwent generator and lead replacement surgery. The patient was seen at a follow-up appointment and the severe cough had disappeared but the patient was still a little hoarse and his voice went away when he spoke for a longer time. At the moment the treating physician believes the paresis is due to the prolonged surgery for replacing the lead and the generator. No further interventions have been planned so far for the reported paresis due to the fact that the symptoms are getting better over time and the situation with coughing and hoarseness is improving, the physician plans to wait for natural recovery of the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2282315


Title: Re: Voice/Speech
Post by: dennis100 on August 23, 2017, 06:05:51 AM
Model Number 101
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported by the pt's physician that the pt had been having an increase in seizures for the past 2 months. The pt was having 3-5 seizures a day, but it was not known if this was above or below the pt's pre-vns frequency. Device diagnostic tests showed the device to be properly functioning. The pt had no changes in medication prior to the increase. Further info indicated the pt was being referred for a replacement surgery. Attempts for further info have been unsuccessful to date.
 
Event Description
Additional information was received through clinic notes indicating that the patient experienced suicidal thoughts and voice alteration during the same time period in which an increase in seizures was reported. At the moment good faith attempts to obtain further information regarding the event have been unsuccessful to date.
 
Event Description
Further information was received from the treating nurse indicating the patient is not being treated for depression and there is a likelihood the event of suicidal ideations are related to medication.
 
Event Description
Analysis on the returned generator was completed by the manufacturer. Analysis of the returned generator indicated the device performed according to functional specifications. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
Additional information was received from the surgeon indicating the patient underwent generator replacement surgery. Information from the area representative clarified the patient was explanted due to prophylactic replacement and the device was interrogated successfully prior to explant. The explanted generator was returned to the manufacturer and remains under analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340063


Title: Re: Voice/Speech
Post by: dennis100 on August 25, 2017, 03:31:00 AM
Model Number 102
Event Date 10/01/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient¿s vns was explanted. It was unknown when and where the surgery occurred; therefore, product return attempts cannot be made. Good faith attempts to the physician for further information were unsuccessful.
 
Event Description
It was reported that a patient's device could not be interrogated. The wand was repositioned several times and the programming system worked successfully on other patients a few days prior to this appointment however communication could not be established with this patient's device. The physician stated the last time the device was checked was about a year ago. The patient could feel stimulation in the neck and was having voice alteration with magnet stimulation. There was no increase in seizure activity. The patient was reporting some painful stimulation in the chest area over the past few weeks which led to the appointment. The wand battery was checked and was verified to be sufficient and the handheld device was not plugged into the wall. All cable connections were verified to be secure however the physician would obtain various warning messages indicating that communication with the patient's device could not be established. The physician was unsure as to whether or not the patient's device was at end of service and wanted to have the device checked again. It was suggested to the physician that the device be checked soon so there are no breaks in the patient's therapy if the device is at end of service. A battery life calculation was performed using the patient's programming history available in the manufacturer's programming history database which indicated the device was at or nearing end of service. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2316948



Title: Re: Voice/Speech
Post by: dennis100 on August 28, 2017, 02:40:21 AM
Model Number MODEL 250
Event Date 09/18/2010
Event Type  Malfunction   
Event Description
Additional information was received from the patient's neurologist indicating that he did not see the patient (b)(6) months prior when the patient stopped feeling stimulation and had the increase in seizures and he had not seen the patient since, so he did not know if the re-programming of the device had helped with the seizure control. The physician indicated that he did not believe that the patient's symptoms were related to the device being programmed off. The physician was not able to provide any information regarding the increase in relation to pre-vns levels and said that the increase with in the patient's partial as well as secondary gtc seizures. The physician indicated that he did not know what had happened, and attempts for patient programming history have been unsuccessful to date. The physician indicated that the replacement would be for prophylactic reasons and not related to the increase in seizures. Revision has not occurred to date.
 
Manufacturer Narrative

Event Description
It was reported through clinic notes received on (b)(6) 2011, that the patient has been experiencing an increase in seizures, with three gtc seizures over the last (b)(6) months. The patient has noticed an increase in seizures over the last (b)(6) months including his simple partial seizures which occur approximately once every three weeks. The patient has a pre-vns history of 3-4 seizures /month which decreases to one seizure every 6-8 months with vns. The patient was concerned that his vns was not working as he was no longer experiencing voice alterations with stimulation. This lack of voice alteration has also been observed over the last (b)(6) months. The patient was seen at an appointment on (b)(6) 2011 and the vns was interrogated and found to be programmed to 0. 0ma. It was indicated that this was unexpected as at the patient's last appointment the vns was interrogated at 1. 0ma. As the patient's output current was programmed to 0. 0ma the increase was attributed to the vns being programmed off. It is suspected that a faulted diagnostic may have occurred at the patient's last appointment resulting in a change to the patient's settings. Attempts for additional information to confirm this event are underway. The patient has been referred for a generator replacement procedure. Revision is likely, but has not occurred to date.
 
Event Description
Programming history was received and reviewed. During the review an anomaly was identified. On (b)(6) 2010, the patient was interrogated and a faulted diagnostic test occurred. The patient was not re-interrogated following the faulted test. The patient was re-programmed; however the output current and magnet current were left at 0. 0ma. The patient's device was not re- interrogated until (b)(6) 2011; when the patient was re-programmed to 1. 0ma.
 
Manufacturer Narrative
Analysis of programming history. Event description, corrected data: it was inadvertently reported on follow up report 1, that the physician did not attribute the reported events to the device being programmed off; however the physician did attribute the events to loss of stimulation.
 
Event Description
Additional information was received that the patient had a prophetic generator replacement. Good faith attempts for product return have been unsuccessful to date.
 
Event Description
Additional information was received that the generator was discarded the day of surgery so it will not be return to the manufacturer for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2386415


Title: Re: Voice/Speech
Post by: dennis100 on August 28, 2017, 02:41:32 AM
Model Number 102
Event Date 07/27/2011
Event Type  Malfunction   
Event Description
Additional information was received indicating the patient is being referred to a surgeon for likely lead revision.
 
Manufacturer Narrative

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator. Corrected data: initial report inadvertently did not include the appropriate evaluation for the evaluation of the x-rays and identification of likely improper lead pin insertion.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate report type was also "30-day" report.
 
Event Description
Additional information was received indicating surgery to resolve the high impedance has occurred. The generator was replaced prophylactically due to the patient's desire for a smaller model generator. During surgery, the physician noted that the setscrew appeared to be loose when removing the existing generator. Lead impedance following generator replacement was normal. The lead was not revised. The explanted generator was returned and is currently undergoing analysis.
 
Event Description
Analysis of the explanted generator has been completed. The generator performed to specifications and no anomalies were observed. No obstructions were noted that would have prevented full insertion of the lead pin. Since no anomalies were observed, it is likely that the high impedance is due to surgeon error as it appears he did not tighten down the setscrew adequately to secure the generator.
 
Event Description
It was reported that the patient's vns indicated high impedance with a dcdc=4. No clinical adverse events indicating a loss of therapy have been reported. The patient still experiences normal voice alteration during stimulation on times indicating that the patient is still receiving the intended therapy at this time. X-rays were received that indicate that the lead pin was likely not fully inserted during implant surgery resulting in the abnormal impedance. No interventions are planned at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2389913


Title: Re: Voice/Speech
Post by: dennis100 on August 29, 2017, 01:47:18 AM
Model Number 103
Event Date 11/22/2011
Event Type  Malfunction   
Event Description
The additional data received from the more recent patient follow up visits (from (b)(6) 2012) has been reviewed. Review of the data indicates that the device has resumed normal function and is delivering the intended therapy. Additionally, there is no indication of increased battery depletion; however this is from an assessment of an additional two dates of data, at which the device was programmed to lower settings (output=0. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min, magnet output=0. 75ma/,magnet pulse width=500usec/magnet on time=60sec). The battery voltage on 06/13/2012 was measuring 3. 395v and 5. 946% of the battery was consumed.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: supplemental report #1 did not indicate that an adverse event occurred. The information has been updated on this report.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the patient was seen in a clinical visit with the neurologist and manufacturer's consultant. Initial interrogation of the vns device showed a vbat < eos message. A system diagnostics was performed which showed results within normal limits of an impedance value of 3500 ohms and 1 ma delivered. The patient was programmed to 0. 5 ma output and 0. 75 ma magnet output without incident. The patient's mother used the magnet post programming and was able to hear the voice alteration with the magnet stimulation. The patient had no other visible signs of stimulation. The patient will return in (b)(6) weeks for interrogation and to be programmed up to an output of 0. 75 ma. No surgeries, medical procedures, mri, or activities where the patient may have been shocked occurred. The patient is going to continue with titration and there are no plans for battery replacement at this point.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received on (b)(4) 2012, when it was reported that at the patient's clinical visit that day the vns device was functioning well and there was no "vbat less than threshold" message present.
 
Event Description
On (b)(6), 2012 additional programming history was reviewed, no anomalies were observed.
 
Event Description
Additional information was received on (b)(6) 2012, when a copy of the physician's programming history was reviewed by the manufacturer. Review of the patient's programming history confirmed that the generator had been disabled sometime between the patient's appointment on (b)(6) 2011 and the appointment on (b)(6) 2011, due to the battery voltage being less than the end of service threshold level. The manufacturer's consultant reported that the patient's mother stated that the patient is no longer having absence seizures, but is now having complex partial seizures and that they are not hearing any voice alteration when swiping the magnet. The patient had only 5 seizures in (b)(6) 2011 and had 16 seizures in (b)(6) 2011. However, the device has been disabled so is not providing any therapy at this time. The consultant is recommending to the physician that the patient come back in to see the physician and they try and re-program the generator on along with perform diagnostics.
 
Event Description
On (b)(6) 2011 a vns treating neurologist reported that when she interrogated the vns patient's generator, she received a message that the vbat was less than threshold and the pulse was disabled. She hit "ok" on the message and another message appeared that said she had selected an output greater than 0. 25ma but the physician had not been attempting to program the patient. The patient's settings were listed as output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magneto output=1. 25ma/magnet frequency=500usec/magnet on time=60sec even though the error message she had received had stated that the output was 0ma. The physician then performed system diagnostics and the results were within normal limits of output=ok/lead impedance=ok/output current=1ma/lead impedance=3288ohms/ifi=no. She was unable to program the patient's settings. The physician tried again with another programming system and received the same error message when she interrogated the patient. System diagnostics also showed the same results with the new programming system. At this time no interventions are planned. The patient has not had a recent surgery nor an mri. The patient was last seen on (b)(6) 2011 and everything was normal. The patient's mother reported that she thinks the magnet is still working. The manufacturer's consultant reported that he was able to obtain a copy of the programming history from the physician's handheld and that he would send it to the manufacturer for review; however it has not yet been received by the manufacturer.
 
Event Description
On (b)(6) 2012, additional information was received that the patient is still implanted with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2375610


Title: Re: Voice/Speech
Post by: dennis100 on August 30, 2017, 01:22:33 AM
Model Number 302-20
Event Date 07/11/2011
Event Type  Injury   
Manufacturer Narrative
Correction: patient identifier was inadvertently reported incorrectly on the initial medwatch and has been corrected. (b)(4).
 
Manufacturer Narrative

Event Description
It was reported by a neurologist that a vns patient experienced coughing, hoarseness, and difficulty swallowing after his vns settings were increased from. 75 ma to 1 ma. The treating physician indicated the patient then experienced vocal cord paralysis and the patient has not recovered. Moreover, the neurologist indicated that when the patient had vns explanted due to high impedance (mfr report # 1644487-2011-01816), the surgeon saw that the superior electrode had been pulled partially from the nerve and the tissue was scarred. The patient's mother indicated the patient did not have a physical injury that could have contributed to the event. At the moment, good faith attempts to obtain further information regarding the event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2372099


Title: Re: Voice/Speech
Post by: dennis100 on August 30, 2017, 01:23:17 AM
Event Date 01/01/1999
Event Type  Injury   
Manufacturer Narrative
Article citation: operative and technical complications of vagus nerve stimulator implantation, operative neurosurgery, december 2010, vol. 67, ons490; spuck, s, tronnier, v, orosz, i, schonweiller, r, sepehrnia, a, nowak, g, and sperner, j.
 
Event Description
During manufacturer review of the published article "operative and technical complications of vagus nerve stimulator implantation, operative neurosurgery, december 2010, vol. 67, ons490; spuck, s, tronnier, v, orosz, i, schonweiller, r, sepehrnia, a, nowak, g, and sperner, j", it was identified that a patient had the vns explanted due to lack of efficacy and stimulation-dependent side effects of torticollis, hoarseness, and sleep disorders. The time of the event is unknown, as the article was a retrospective review from 1999 through 2008. Attempts to the author for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2360179


Title: Re: Voice/Speech
Post by: dennis100 on August 31, 2017, 02:22:52 AM
Model Number 300-20
Device Problem Mechanical issue
Event Date 11/07/2011
Event Type  Malfunction   
Event Description
Follow-up from the physician¿s office was received (b)(6) 2016 and provided that the vns was still programmed off. The pain was not suspected to be due to the vns, but pain was experienced on the same side as the vns when the dbs goes off. It was decided to remove the device due to the continued complaint from the patient, even though vns was not expected to have been causing the pain. The generator and the entire lead were removed on (b)(6) 2016, and it was stated the patient has not complained regarding the pain since explant. The explanted generator and lead was received for analysis, which is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the generator. The device output signal was monitored while placed in a simulated body temperature environment. Results showed no signs of variation in the output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The diagnostics were as expected for the programmed parameters. A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 989 volts and was not at end-of-service. The downloaded data revealed that 23. 935% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned lead. Abraded openings were noted on the outer silicone tubing. The reported lead fracture was not verified within the returned lead portion. Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Analysis of programming history. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the patient is scheduled to have the device removed. No known surgery has occurred to-date.
 
Event Description
Additional information was received on (b)(6) 2011, when it was discovered that the patient had a surgery consultation on (b)(6) 2011. The patient's device was disabled because the patient was still feeling painful stimulation in the chest area. Although surgery is likely, it has not yet occurred.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns patient was seen by them yesterday and a high impedance warning message came up when the patient was interrogated. The physician turned the patient up from an output of 1. 5 ma to 2. 5 ma and the patient was complaining of feeling painful stimulation in the neck at the electrodes. He turned the patient back down to 1. 5 ma and the patient no longer felt any painful stimulation. The manufacturer's consultant visited the physician's office and the patient came in again for evaluation. The patient's generator was interrogated again and the high impedance warning message was again received. A system diagnostics test was performed which showed lead impedance=high/impedance value >10,000ohms/ifi=no. The patient is still receiving stimulation however and is at output = 1. 5ma/frequency = 30hz/pulse width = 250usec/on time = 30sec/off time = 3min/magnet output = 1. 5ma/magnet on time = 60sec/magnet pulse width = 500usec. They know the patient is still getting some stimulation since the patient's voice fluctuates with stimulation; this is normal for the patient. The manufacturer's consultant stated that x-rays would be taken and sent to the manufacturer for review. The patient was reported not to be feeling any pain whatsoever. The physician decided to leave the patient programmed on despite the manufacturer's recommendation to turn it off. The patient is being referred for revision surgery. It was also reported that the patient wants to have brain surgery independent of vns. The patient's x-rays were received by the manufacturer and during the x-ray review, whether the lead wires were intact at the connector pin could only be confirmed for one of the lead pins, the other was unable to be assessed due to poor contrast of the x-ray image. The lead pins could be visualized past the connector blocks and therefore appeared to be fully inserted. Based on the x-ray received, no gross lead discontinuities or sharp angles appear to be present. However, an unpronounced lead fracture cannot be ruled out. Using the battery longevity tables, with the patient's settings the patient has about 10 years left until end of service with his battery. Although revision surgery is likely, it has not yet occurred.
 
Event Description
It was later reported by a medical professional that the patient experiences periodic neck pain when his dbs device is turned on. The dbs was turned off and symptoms resolved. It was stated the patient elected not to revise the device. No known surgery has occurred to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355453



Title: Re: Voice/Speech
Post by: dennis100 on September 01, 2017, 01:39:34 AM
Model Number 102
Event Date 12/12/2011
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful as the initial reporter indicated that this was no longer their patient and refused to comment on the reported events.
 
Manufacturer Narrative

Event Description
It was reported through clinic notes received on (b)(6) 2011 that the patient has a medical history positive for obstructive sleep apnea. The patient is being treated with a cpap machine. It is currently unknown if the apnea is caused or exacerbated by vns. It was also mentioned in the clinic notes that the patient had a "vocal cord abnormality". The exact abnormality is unknown as is the relationship of the abnormality to vns. It was stated however that the patient has undergone injections of botox into her vocal cord. Attempts for additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2407802


Title: Re: Voice/Speech
Post by: dennis100 on September 02, 2017, 02:12:18 AM
Event Date 04/01/2010
Event Type  Injury   
Event Description
It was reported that a vns pt had a history of seizures and began to have an increase in seizures following implant of the vns lead and generator. The pt reportedly went to the physician and met another pt with similar issues which is housed in manufacturer report # 1644487-2012-00028. The physician reportedly "fined-tuned" the vns settings however it was not indicated if this resolved the increase in seizures. The pt's report also indicated he or she experienced hoarseness however this later improved with the fine tuning. This information was reported to the fda in (b)(6) 2010 however it was not believed that this event had been passed on to the manufacturer. The pt's seizures were noted as worsened with nine per day and sometimes five every ten hours. The pt reportedly passes out after her seizures and was in the hospital for three days following the last episode per the report. Attempts for further information are not possible as the pt and physician information were not available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403801


Title: Re: Voice/Speech
Post by: dennis100 on September 04, 2017, 06:55:36 AM
Model Number 102
Event Date 12/15/2011
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic generator replacement. Reporter indicated that pre-operative diagnostics were good with eri = no and the lead looked good on inspection. Explanted generator was returned to the manufacturer, but analysis is pending.
 
Event Description
It was reported that the patient was referred for revision surgery for an unknown reason. Further information reveals that the patient was having painful stimulation in her throat and voice changes and thinks there is something wrong with her device. The patient wanted the device relocated which the physician felt was okay since it had been implanted for over 6 years. Diagnostics performed were good (exact results not given) and her settings were lowered to help with the pain. Follow-up with the physician reveals that no patient manipulation or trauma occurred that is believed to have caused or contributed to the events. No causal or contributory programming or medication changes preceded the onset of the events. Revision surgery is planned, but has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. A battery life calculation was performed which showed 1. 79 years until the elective replacement indicator shows as yes. The last system diagnostics from (b)(6), 2008 showed the device to be functioning properly with output=ok/lead impedance=ok/dcdc=0/eri=no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2458675


Title: Re: Voice/Speech
Post by: dennis100 on September 05, 2017, 02:04:47 AM
Model Number 302-20
Event Date 12/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Confirmation was made by the treating nurse of the explant surgery and the explanted devices were returned to the manufacturer for analysis. Analysis of the returned generator indicated the pulse generator performed according to functional specifications. Analysis of the returned lead indicated breaks were identified in the negative coil. Scanning electron microscopy images of the negative broken coil ends show that pitting or electro-etching conditions have occurred at the coil ends. However, due to metal dissolution and surface contamination, the fracture mechanism cannot be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Additional information was received from the area representative indicating the patient was scheduled to undergo generator and lead explant surgery. Information from the explanting hospital indicated the patient was explanted of both generator and lead due to "excessive scarring around the vagus nerve which caused high impedance" and the patient was not implanted with another system.
 
Event Description
It was reported by a patient's mother that a vns patient's voice would not change when using the magnet. The patient had recently undergone vns revision surgery ((b)(6) 2011) in which the lead was placed at lower vagal nerve proximity. Post-operatively, patient again did well but this past december mom noted that whenever they used the vns magnet, the patient's voice doesn't change anymore. Further information was received from the area representative indicating high lead impedance was encountered (dc dc 7 on both system and normal mode diagnostics) and the patient's device was disabled by the treating physician. X-rays were taken and sent to the manufacturer for review. Review of x-rays indicated the generator to be in normal placement, filter feed thrus appeared to be fully inserted. The electrodes were visualized in the neck and appear in the proper orientation. There did not appear to be any gross discontinuities or sharp angles in the images provided. At the moment revision surgery is likely but has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2446714


Title: Re: Voice/Speech
Post by: dennis100 on September 05, 2017, 02:05:36 AM
Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported via clinic notes dated (b)(6) 2011 and received on (b)(4) 2012 that a vns pt was having more frequent seizures. The seizures were said to be "minor" lasting 30-45 seconds. The pt was not having any grand mal seizures. The pt's caregiver was wondering if the pt's device was working as she wasn't having any cough or voice alteration with magnet swipes. It was noted that her vns was at full capacity and all system tests were normal. The physician also checked the magnet and it was also working properly. No changes were made to the pt's settings as the battery was good and the magnet was working. The physician stated it was likely the pt has become accustomed to the situation and is no longer experiencing the side effects (cough/voice alteration). The last note stated that the pt appears to have these seizures when vomiting and otherwise, her seizure control is good. Follow up with the physician revealed that the relationship of the increase in seizures to the pt's pre-vns baseline levels was unk as the physician was not the original physician for the pt when she was initially implanted. The relationship of the increase in seizures to the vns device is also unk, however, as the site was provided a battery life calculation that indicated the device was nearing end of service, they thought it would be best to replace the generator prior to the battery depleting so seizure control would not worsen. There were no apparent precipitating factors prior to the onset of the increase in seizure activity. The physician did not have any add'l info to provide. The pt's generator has been explanted and replaced. The explanted device has been returned to the mfr and is currently undergoing product analysis.
 
Event Description
On (b)(4) 2012, product analysis was completed and approved for the explanted generator. The generator was returned due to prophylactic replacement. Proper functionality and ability of the pulse generator to provide appropriate programmed output currents were verified. There were no performance or any other type of adverse conditions found with the pulse generator. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2459592


Title: Re: Voice/Speech
Post by: dennis100 on September 06, 2017, 08:48:19 AM
Model Number 300-20
Event Date 05/01/2010
Event Type  Injury   
Event Description
It was reported to the manufacturer that a vns patient had developed severe laryngeal narrowing due to laryngeal muscular hypertrophy requiring tracheotomy. It was reported that the patient's symptoms were gradually worse while he was using the vns device with hoarseness and obstructive sleep apnea. Cat scan of their larynx showed irregular and thickened true and false left vocal cords. It appeared like an infiltrative mass. Their vns device was disabled: (b)(6) 2010. He developed progressive laryngeal obstruction due to hypertrophy of his left vocal cords requiring tracheotomy that was performed on (b)(6) 2010. The patient did not have a history of this prior to vns implantation. His symptoms and laryngeal hypertrophy gradually resolved after stopping the vns. His voice and breathing returned to normal in a few months. Tracheotomy was removed on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434152


Title: Re: Voice/Speech
Post by: dennis100 on September 08, 2017, 10:47:13 AM
Model Number 302-20
Event Date 09/01/2010
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2011 when it was reported that the patient was hospitalized due to an unknown reason. The patient was to undergo revision surgery however there were concerns over the length of time that was going to pass prior to the surgery occurring due to scheduling conflicts. Good faith attempts to obtain the reason for hospitalization were unsuccessful. A review of the patient's programming history available in the manufacturer's programming database revealed that the patient's device was programmed off on (b)(6) 2010. The patient underwent revision surgery where the lead and generator were both explanted and replaced and good faith attempts to obtain the explanted product will be performed.

Event Description
It was initially reported by the pa that the vns pt's device was showing low impedance on recent diagnostics performed. The pt was said to have not been followed for approximately the last two yrs. It was noted that the pt is also being followed by another neurologist for medication mgmt. The pa also indicated that the pt is said to have been seizure-free for approximately 2 yrs. The pt indicated that about two months prior to the report, he was no longer feeling the stimulation which used to cause him to cough and have voice alteration during the stimulation. When the pt's output current was increased significantly, there was no coughing or voice alteration as expected. When diagnostics were performed, the diagnostics indicated that the dcdc value was 0. Review of the mfr's programming history indicates that the pt's dcdc-value was 2 at the time of implant and a 1 on (b)(6) 2008. The pt was said to be referred for x-rays, but a copy has not been sent to the mfr for review. Good faith attempts to obtain additional info have been unsuccessful to date.

Event Description
Good faith attempts to obtain the explanted devices were unsuccessful.

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=1937605


Title: Re: Voice/Speech
Post by: dennis100 on September 10, 2017, 01:15:04 AM
Model Number 302-20
Event Date 02/06/2012
Event Type  Malfunction   
Event Description
Reporter indicated the patient had vns generator replacement only on (b)(6) 2012. Vns diagnostics with the new generator and resident lead still resulted in high lead impedance, but the surgeon elected not to replace the lead. As the lead pin was reinserted into the new generator and high lead impedance still resulted, a lead pin issue has been ruled out and a lead fracture appears more likely as a cause for the high impedance. The new generator was programmed on to deliver therapy. The plan of care is to observe the patient for any changes in seizures. The surgeon was advised to replace the lead due to the high lead impedance, as it could not be certain that therapy was being delivered as intended. Follow up with the explanting hospital revealed the generator was discarded.
 
Event Description
Reporter indicated the patient will be monitored clinically with the vns "on" for now.
 
Manufacturer Narrative
Conclusion: device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that a pt had high lead impedance with vns diagnostics testing. The pt was also experiencing voice alteration with her vns stimulation, and this was a normal event for her. The vns was not disabled at the reporter's discretion, and the pt was not having any adverse events. The pt had no trauma and does not manipulate the vns. Prior to (b)(6) 2012, the pt had not been seen by the reporter since (b)(6) 2006. Surgery to replace the vns lead and generator is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2481324


Title: Re: Voice/Speech
Post by: dennis100 on September 11, 2017, 03:57:20 AM
Model Number 302-20
Event Date 03/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient experienced dysphonia during vns stimulation. The patient went to the er and was diagnosed with pharyngitis. The patient was referred to an ent in which fiberoptic laryngoscopy was performed. The results were indicative of left vocal cord hypomobility with no major injury. At the moment attempts for further relationship to vns therapy have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2548208


Title: Re: Voice/Speech
Post by: dennis100 on September 12, 2017, 12:32:42 AM
Model Number 103
Event Date 11/11/2011
Event Type  Injury   
Event Description
It was initially reported by a company representative that a patient was experiencing adverse events that could be caused by vns. Additional information was received from the area representative indicating the patient suffered from postoperative dysphonia along with moderate cough and hoarseness as using the magnet. Nonetheless, fiberoptic laryngoscopy performed on the patient indicated left vocal cord paralysis that was compensated by the right vocal cord. The patient has been reported to be recovering tone and no interventions have been planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2538680


Title: Re: Voice/Speech
Post by: dennis100 on September 13, 2017, 01:51:36 AM
Model Number 302-20
Event Date 02/29/2012
Event Type  Malfunction   
Event Description
The explanted generator and lead were returned to the manufacturer on (b)(6) 2012. Product analysis on the generator has been completed; however analysis on the lead is underway. During product analysis of the generator, there were no anomalies found. The generator performed according to functional specifications.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2012, indicating that the patient went for replacement on (b)(6) 2012, however, the surgeon was not able to replace the vns lead and generator at that time so the devices were removed and not replaced. Replacement has not occurred to date. Attempts for product return have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported on (b)(6) 2012, that the patient had high impedance on normal and system mode diagnostic tests performed on (b)(6) 2012. It was indicated by the nurse that the patient could still feel stimulation and was still having voice alteration with stimulation, so it was felt that the patient may be receiving some therapy. There was also no reported pain. X-rays were performed and were sent to the manufacturer for review. The generator placement appeared normal. Proper insertion of the connector pin could not be confirmed based on the angle of the images provided. The generator feed-through wires appeared to be intact. The electrodes appeared to be in proper alignment. The lead wires appeared to be intact at the connector pin and no gross fractures or lead discontinuities could be visualized on the lead portion assessed. There was a small portion of the lead body behind the generator that was unable to be assessed. In the x-rays received, a lead discontinuity or sharp angle was not observed; however the presence of a micro-fracture could not be ruled out. Proper pin insertion could also not be assessed based on the images provided. Note that as a portion of the lead was located behind the generator, a full assessment of the lead could not be performed. Additional information was obtained from the nurse indicating that the patient was also experiencing an increase in seizures starting around (b)(6) 2012. This was felt to be related to the patient's anxiety over the device not functioning properly. The patient had been experiencing complex partial seizures with rare secondary generalization. Additionally it was reported that the patient has fallen twice. The nurse indicated that this was a likely cause of the high impedance, however this cannot be confirmed. Revision is likely but has not occurred to date.
 
Event Description
Product analysis on the lead was completed on (b)(4) 2012. During analysis a break was identified in one of the lead coils. Scanning electron microscopy images of the broken coil show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution and/or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2515580


Title: Re: Voice/Speech
Post by: dennis100 on September 16, 2017, 12:52:42 AM
Model Number 102
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative
Article citation: aron, margaret, helen vlachos-mayer, and dominique dorion. "vocal cord adduction causing obstructive sleep apnea from vagal nerve stimulation: case report. " the journal of pediatrics (2012): 868-70. Print.
 
Event Description
It was reported through a scientific article that a vns patient nocturnal episodes of apnea as well as frequent diurnal episodes of transient dysphonia associated with apparent "choking" episodes. The patient's initial vns parameters were 500-ms at 20 hertz every 5 minutes at an intensity of 2. 25 ma. A total of 178 desaturations were recorded, representing an average of 12. 4 desaturations per hour. Detailed evaluation revealed regular desaturations every 5 minutes, corresponding to the frequency of vns. An otolaryngologist investigated the patient's reported choking episodes and episodic dysphonia. On visualization with a flexible laryngoscope, the patient's vocal cords were seen to adduct with each stimulation by the vns device. The settings were adjusted to maintain satisfactory seizure control while diminishing the apneic episodes. An appropriate equilibrium was reached by changing the vns stimulation frequency to 30 hz. At this setting, the patient's seizures were adequately controlled, all apneic episodes were eliminated, and choking episodes were resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2583979


Title: Re: Voice/Speech
Post by: dennis100 on September 16, 2017, 12:53:34 AM
Model Number 103
Event Date 01/27/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.
 
Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.
 
Event Description
Clinic notes were received on (b)(6) 2012 from, a physician's office. The notes covered the patient's physician visit from (b)(6) 2011 to (b)(6) 2012. The patient was implanted on (b)(6) 2011, at which time the device was not programmed on. On (b)(6) 2011, notes reported pain at the surgical site, hoarse voice, and "multiple grand mal seizures after vns. " the vns incision lines looked good, were both healing well, without tenderness. The neck incision had surrounding swelling. On (b)(6) 2012, notes state that the patient's hoarse voice was gone, there was no more pain at the vns site, and no change in frequency. The notes indicate that the patient's device was turned on, and the patient did not feel anything. No settings are provided for this date, and initial interrogation at the next appointment indicates normal mode and magnet output currents were 0 ma. On (b)(6) 2012, the patient reported an increase in seizures and duration, along with aggression. The notes report that the magnet did seem to stop the seizures and make them shorter; however, settings from this date indicate that the device was programmed off until this appointment. The patient experienced painful magnet mode stimulation for the first magnet activation. On (b)(6) 2012, it was stated that the patient felt he had an upper respiratory infection the previous week. The patient turned during sleep and "felt spinal cord electricity," a lack of consciousness for 30 minutes, and then numbness throughout his head, which continued. There was now a change in seizures: the patient had a warning and then an out of body experience. He was unable to use the magnet during this time. The patient's aggression was reported to be less, he did not have any more headaches, but he did have neck pain. On (b)(6) 2012, notes reported that the seizures did decreased but have recently reoccurred. The patient occasionally coughed with vns but had no serious ill effects. The patient did experience coughing and choking during magnet stimulation; however, the magnet did abort seizures well. The patient's vns was adjusted, and the physician ensured that the patient tolerated both normal mode and magnet stimulation. On (b)(6) 2012, the patient was seen for increased blood pressure and a check of the patient's vns after the patient held a shocking dog collar while the collar was charging. The patient's vns settings were altered. This event is captured in mfr. Report # 1644487-2012-01066. On (b)(6) 2012, notes report that the patient was having the same amount of seizures (4/day) and no issues since turning the stimulator back on from the collar incident. On this date, the patient's settings were adjusted. On (b)(6) 2012, the patient was seen again for marked aggression, agitation, and an increase in grand mal seizures since the adjusted settings the previous day. The magnet did not seem to stop the seizures. The patient's mother taped the magnet over the patient's vns to disable the device, and all symptoms stopped. The patient's settings were reduced to (b)(6) 2012 settings. On (b)(6) 2012, the patient was reported to have a bad mood, irritable, snapping, and having more seizures. He was saying things he wouldn't have in the past and demonstrating almost manic-depressive type behavior. The patient became violent, hit his parents, screamed, held his head, demonstrated symptoms like a grand mal seizure, and later bit his finger. The patient was not able to perceive normal mode or magnet stimulation. The patient's mother felt that things were going well with vns at first, but felt as though the seizures were never really controlled. The patient's normal mode output current was programmed off, and the magnet was programmed to a higher output current that resulted in a cough lasting less than 5 seconds. Follow up with the nurse practitioner revealed the following information: the patient's increase in seizures was below his pre-vns baseline. The patient was treated by his primary care physician for the upper respiratory infection; however, the nurse practitioner did not think that the infection was related to vns. When asked about the change in seizure reported on (b)(6) 2012, no additional information regarding the change in seizures was available; however, the change was attributed to anxiety. The patient's anxiety was caused by vns: the presence of the device and the surgery. The nurse practitioner believes that the vns causes the patient anxiety. The anxiety, in turn, propagates more seizures. The patient was placed on medication to assist with the anxiety and sleep. There are discrepancies between the settings from appointment-to-appointment that may be due to recording errors. Attempts to obtain the physician's flashcard to review the patient's complete programming history are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000


Title: Re: Voice/Speech
Post by: dennis100 on September 17, 2017, 02:11:56 AM
Model Number 103
Event Date 05/24/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012, indicating that the explanted products were discarded. It was also confirmed that the generator and most of the lead were removed during the surgery. The electrodes however remained on the nerve.
 
Manufacturer Narrative

Event Description
It was reported by the patient that he was experiencing some pain and swelling in his left face that was making it difficult to eat and chew. The patient indicated that he wished to have his device explanted. The patient was then scheduled for a consult with a surgeon to have the device removed. Follow up with a nurse at the patient's treating neurologist's office revealed that the patient has been in pain for a while and that the device has been off for about a year. She indicated that she has not seen the patient since his consult with the surgeon, but she has spoken with him and he seems happy to have the device taken out. She indicated that they are unsure is this is just the patient, or if the device may have been implanted incorrectly, but she indicated that the patient does seem to be in legitimate discomfort. She was not able to provide any additional information. The patient had previously reported issues with pain, pain with stimulation, and voice alterations, starting following a lead replacement in (b)(6) 2011, however at the time these were thought to be mild and no interventions were taken. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(4) 2012, indicating that the patient had a vns removal surgery (b)(6) days prior on (b)(6) 2012. It is unclear at this time if only the generator was removed or if the lead was removed also. Attempts for product return and additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2616944



Title: Re: Voice/Speech
Post by: dennis100 on September 19, 2017, 02:50:12 AM
Model Number 103
Event Date 04/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by the patient's mother that the patient had been experiencing stridorous breathing that appeared to be related to his vns stimulation. The patient also underwent a sleep study in (b)(6) 2012. Follow up was performed with the patient's treating neurologist who did not believe that these issues were related to vns. However, additional follow up with the epileptologist who performed the sleep study indicated that the patient's breathing issues were in fact related to vns and the patient's rapid cycle. She stated that the sleep study showed a correlation between the patient's issues and vns stimulation. Per the physician, the sleep study showed desaturation at night with stimulation as well, resulting in sleep apnea. During the day, the desaturation was not occurring, however, the patient was having voice alterations with stimulation as well as stridorous breathing. The patient's settings were changed from 30secs on and 1. 8min off to 30secs on and 5min off, and the issues resolved completely. It was indicated that the patient was not experiencing desaturation any more and the voice alterations and breathing issues with stimulation went away before the patient left the office on the date of the setting adjustment. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2666922



Title: Re: Voice/Speech
Post by: dennis100 on September 20, 2017, 01:37:03 AM
Model Number 102
Event Date 01/01/2010
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes from a vns treating physician were received. The clinic notes dated (b)(6) 2012 revealed that over the years the severity and frequency of the patient's seizures have gradually increased. The patient reports two different types of seizures; the first type he reports feeling confused and may lose balance and fall. These episodes are relatively short, lasting seconds to a few minutes. The second type of episodes represents secondary generalized convulsions, which also last only a few minutes. The patient continues to have approximately 1-3 seizure episodes per week. The clinic notes list the patient's medical history consisting of coronary artery disease, hyperlipidemia, and coronary atherosclerosis of native coronary artery. The patient experiences hiccups and voice alteration with vns stimulation. The patient was prescribed baclofen for his hiccups. The physician indicated that when the patient has his vns replaced, they may seek a lower target dose in the hopes of avoiding hiccups which the patient associates with his vns settings. A battery life calculation was performed which showed 5. 46 years remaining until eri=yes. Attempts for further information from the physician have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2657377


Title: Re: Voice/Speech
Post by: dennis100 on September 20, 2017, 01:37:45 AM
Model Number 102
Event Date 06/17/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient experienced voice alteration and aspiration due to unknown reason. The patient was referred to an ent and at the moment are pending results from evaluation. Moreover, information from the treating neurologist indicated the generator was off at the time of the events. The patient had little dysphonia which has disappeared. Corticosteroid therapy was started and the voice had almost normalized. Aspiration was found by ent physician and a reported swallowing difficulty was present pre-vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2656871



Title: Re: Voice/Speech
Post by: dennis100 on September 21, 2017, 12:42:21 AM
Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.
 
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613


Title: Re: Voice/Speech
Post by: dennis100 on September 22, 2017, 01:08:58 AM
Model Number 100
Event Date 08/14/2005
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient had generator replacement in (b)(6) 2006 due to end of service which was causing an increase in seizures, mood instability and voice alteration, per the referring physician's office. Review of the programming/diagnostic history available in the in-house database was performed which revealed that there was intermittent high impedance which was observed during a systems diagnostic test on (b)(6) 2005. A systems diagnostic test was performed before and after the high impedance results on this day which both resulted in okay results. In addition on (b)(6) 2004, the same event occurred where high impedance was observed in the second systems diagnostic test. The last system diagnostic test on (b)(6) 2006 resulted in okay results. It is likely that there the lead pin was making intermittent contact with the generator header. After reinsertion of the lead pin after generator replacement in 2006, contact with the generator header was restored and diagnostics were all okay. Follow up with the referring physician's office revealed that the voice alteration was believed to be related to intermittent high impedance. No patient manipulation or trauma occurred that is believed to have caused or contributed to the event. No x-rays were taken. No additional information was provided. However, the increase in seizures and mood instability are believed to be related to the generator end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2707466


Title: Re: Voice/Speech
Post by: dennis100 on September 23, 2017, 03:17:17 AM
Model Number 102
Event Date 07/06/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Reporter indicated the patient's vns generator has been able to be successfully interrogated.
 
Event Description
Reporter indicated a patient's vns generator was unable to be interrogated with two different programming systems. The vns was able to be interrogated at the previous appointment on (b)(6) 2012. The patient does feel the vns stimulating and is experiencing voice alteration with the stimulation. The vns is not believed to be at end of service. Attempts for further information are in progress.
 
Event Description
Manufacturer troubleshooting with the two vns programming systems revealed no issues interrogating a test vns generator with one programmer, and the other programming wand was noted to have a depleted wand battery. After the wand battery was changed, the wand was able to successfully interrogate a vns test generator. Attempts to ascertain whether the patient's vns has been able to be successfully interrogated since the (b)(6) 2012, visit have been unsuccessful to date. As it was reported the patient was sensing vns stimulation and experiencing voice alteration, the vns is likely performing as intended. The reason for the inability to interrogate the patient's generator was likely due to a depleted wand battery or electromagnetic interference with the programming systems. No malfunction was occurring with the two vns programming systems.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2680388


Title: Re: Voice/Speech
Post by: dennis100 on September 25, 2017, 03:23:51 AM
Model Number 102
Event Date 08/14/2012
Event Type  Injury   
Event Description
It was reported by a surgeon that the patient was being scheduled for explant. The surgeon indicated that the device had never really helped with her depression and the patient had been experiencing problems with hoarseness during stimulation and shortness of breath so the patient was being explanted. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when the physician reported that it is unknown when the lack of efficacy, hoarseness, and shortness of breath first began. He also stated that it is unknown what the cause of the lack of efficacy is. It was also unknown what the relationship between hoarseness and the shortness of breath to vns was as well as whether or not they were occurring with stimulation. The physician stated that no interventions have been taken and it was unknown if causal or contributory programming or medication changes preceded the onset of the shortness of breath. The patient does not have a medical history of shortness of breath pre-vns. A battery life calculation was performed on (b)(6) 2012, which showed 5. 16 years remaining until neos=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2743583


Title: Re: Voice/Speech
Post by: dennis100 on September 26, 2017, 01:15:45 AM
Model Number 102
Event Date 12/01/2011
Event Type  Malfunction   
Event Description
It was reported that the patient had vns explant surgery on (b)(6) 2013. Per neurosurgeon notes, the reason for removal was listed as "malfunctioned" vns and patient did not want desire for replacement. The patient has been doing well since explant at this time. The explanted products were discarded after surgery. Therefore, analysis is unable to be performed.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, a vns patient reported not feeling stimulation when the device was stimulating. (the patient typically perceived stimulation through voice alteration and vibration/pressure in the left side of the throat. ) the failure to perceive stimulation began nine months prior. The patient now felt a random shocking sensation from her collar bone to her jaw bone (left side), not associated with stimulation. The patient reported that she has had issues with syncope and was hospitalized in (b)(6) for the syncope. Her device was not checked at the time of hospitalization. The patient's device was working okay when it was last checked; however, the date of "checking" is unknown. At this time, the patient's device was not at end of service; however, the physician who checked the device thought replacement may eliminate some of her problems. On (b)(6) 2012, the patient's physician reported that this vns patient was experiencing erratic stimulation and a sharp pain that she felts from the left side of her neck to her jaw. The patient felt that the device sometimes stimulated constantly; however, other times, she felt the device didn't stimulate for days. The physician stated that the patient had a vasovagal episode in (b)(6) and that the patient went to the emergency room. The physician stated that she turned the patient's device off three weeks prior. The erratic stimulation and sharp pain were still experienced when the device was off. It was noted that the pain occurred randomly. The patient's device was interrogated and found to be at disabled settings. (prior to the device being disabled, the device was programmed to an output current of 1 ma). System diagnostics were run with normal results. While the patient's device noted to be disabled per the interrogated settings, the physician stated that she felt the device was failing or that there was high impedance that was causing the patient to experience erratic stimulation. The physician programmed the patient's device to 0. 25 ma output current. The physician did not believe that any external factors had contributed to the patient's events and believed there to a more serious issue with the device. The patient had reportedly been to see multiple surgeons for vns explant; however, none would explant the device due to the potential for nerve damage. It was noted that the patient did not know when another vasovagal episode would ensue. On (b)(6) 2012, the patient had another appointment with the physician. A manufacturer's consultant was present. At this time, the device was reported to be functioning properly as system and normal mode diagnostics were both within normal limits. It was clarified that the patient was able to perceive normal stimulation (via voice alteration and vibration/pressure); however, the patient was also feeling erratic stimulation. The patient's device was programmed to an output current of 0. 75 ma to perform additional testing to ensure the device was delivering stimulation at the appropriate times. (the testing indicated proper functionality). After the additional testing, the patient was programmed to 0. 5 ma output current. It was clarified that the episode of syncope from (b)(6) 2012, occurred during an appointment with the patient's eye doctor. On this occasion, the doctor did not use numbing drops. This made the patient feel very anxious. As a result, the patient passed out and was taken to the hospital. The patient was not admitted. During the time the device was programmed off, the patient did not experience any episodes of syncope. The patient does not have a medical history of syncope. It was stated that vns did help the patient's anxiety. The physician did not know if the syncope was related to vns. No medication changes preceded the events. On (b)(4) 2012, the patient reported that the physician disabled the device as it stopped stimulating for the last three days and the patient began having some vasovagal feelings again. The patient was requesting full revision.
 
Event Description
Programming history for the patient's generator was reviewed on (b)(6) 2012. The patient's last known settings and diagnostics were from (b)(6) 2012. A battery life calculation on (b)(6) 2012 indicated 6. 93 years remaining. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported this data incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2726181


Title: Re: Voice/Speech
Post by: dennis100 on September 27, 2017, 12:29:52 AM
Model Number 102
Event Date 06/01/2012
Event Type  Injury   
Event Description
The patient's explanted generator was received on (b)(6) 2012. The pulse generator was returned due to "prophylactic replacement". 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. In addition, 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 pulse generator. Attempts for additional information have been unsuccessful.
 
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The notes stated that the patient had a history of complex partial seizures. The patient reported feeling disconnected, being able to hear, and having garbled non-sensical speech. The patient's mother stated that the patient looked glassy-eyed for blank with involuntary movements. The episodes were brief (maybe 5 seconds) but occur multiple times throughout the day. The patient would typically have one seizure per month; however, in june the patient began having seizures multiple times throughout the day. The patient's vns was increased twice in the last few months, but it did not help. The patient reported that vns helped more than medications. The patient was able to manage seizures with just vns for three years. The patient's best seizure control was with vns. The patient had no history of status epilepticus or febrile seizures. The patient's settings from this appointment were provided. Near end of service flag indicated "no. " diagnostic tests were performed, but no results were provided. The notes indicated that the significant increase in seizure frequency was highly suspicious for end of life of the battery. On (b)(6) 2012, the patient underwent prophylactic generator revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2797716


Title: Re: Voice/Speech
Post by: dennis100 on September 29, 2017, 01:59:24 AM
Model Number 102
Event Date 02/17/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
A review of clinic notes dated (b)(6) 2012 found that the patient went to the emergency room the prior week with records from the emergency room dated (b)(6) 2012 showing that she had an increased frequency of seizures. The emergency room records also noted that the patient's white blood cell count in the urine was high suggesting a mild infection. The clinic notes continued to state that the patient had continued to have a change in her pattern of seizures as well described by her husband. The patient's husband stated that the patient seems to have a twisting movement with shaking in the right arm. The patient had one of these seizures during the appointment, and the physician noted that she appeared to be able to move to her husband and that it appears that the patient is seeking comfort from her husband. After the patient's vns was interrogated, an attempt was made to increase the pulsewidth from 250usec to 500usec, but the patient had significant changes in her voice and felt as if there was a sharp, stabbing pain in her neck when the stimulator turned on. Because of this, the stimulator was reversed and the settings were adjusted so that only minor change was made. According to the physician, the battery appeared to be satisfactory and the plan for the future was to adjust the patient's medication. Attempts have been made to get more information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816907


Title: Re: Voice/Speech
Post by: dennis100 on September 30, 2017, 12:42:54 AM
Model Number 103
Event Date 05/25/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was complaining of hoarseness and dysphagia. At the time, it was noted by the surgeon that the patient may have had these issues prior to vns and it was unclear if the issues had worsened with vns stimulation. Additional information was received on (b)(6) 2012 indicating that the generator had been disabled due to muscle tightness and swelling in the neck, which may have always been there, but now the physician felt that the vns may be interfering with his vocal cords. Per the physician, the patient had been evaluated by two separate physicians and his vocal cord was found to be partially paralyzed as a result of the tightness in his neck. The generator was re-enabled on (b)(6) 2012 to lower settings. It was noted that when the device was on 2. 0ma, the patient had reduced tension in neck and shoulders and felt better with a reduction in seizures. The patient has been recommend for speech/ vocal cord therapy for the dysphonia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2881243


Title: Re: Voice/Speech
Post by: dennis100 on September 30, 2017, 12:43:29 AM
Model Number 103
Event Date 08/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the patient reported that she was experiencing a change in seizure pattern in which she was having new seizure types and nocturnal seizures. It is unknown what the relationship of the change in seizure pattern is to vns therapy. In addition, it was reported that the patient went to the hospital the month prior due to concern about her neck bulging with stimulation. The emergency room physician ordered a ct scan of the neck. Per the patient, the emergency room physician stated that it appears the lead is 'on the main vein. ' the patient was instructed to temporarily stop stimulation using the magnet and see the primary vns physician with ct scan results. Per the patient, the vns physician disabled the device and stated that he thought the device was on high settings. The physician recommended the patient follow up with her surgeon; however, the patient does not have the resources to do so at this time. In addition, the patient has also reported experiencing a pain in the neck area, extreme voice hoarseness with stimulation, painful stimulation, difficulty breathing with stimulation, and loss of gross mobility with much of stimulation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887104



Title: Re: Voice/Speech
Post by: dennis100 on October 01, 2017, 12:31:01 AM
Model Number 102
Event Date 08/27/2012
Event Type  Injury   
Event Description
Reporter indicated a patient was experiencing increased seizures and increased seizure intensity. The vns had previously been programmed off due to the patient experiencing hoarseness and coughing, and was currently off. Manufacturer review of vns programming history documents the vns was disabled on (b)(6) 2011, and it is unknown if the vns was ever turned back on after that date. The patient has been referred for possible vns generator replacement. Attempts for further information are in progress.
 
Event Description
Additional information was received indicating the patient's vns was disabled due to psychological issues. It is unclear if the device has been off since (b)(6) 2011, or was turned back on and then disabled at a later date. All attempts to the reporter for clarification and additional information have been unsuccessful to date. Vns generator replacement has not occurred to date.
 
Manufacturer Narrative

Event Description
The patient was referred to the surgeon for explant. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862221


Title: Re: Voice/Speech
Post by: dennis100 on October 01, 2017, 12:31:42 AM
Model Number 102
Event Date 11/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled to have his vns removed. Clinic notes dated (b)(6) 2012, indicated that the patient was experiencing pain on the left side of his chest and numbness at his incision site. Additionally it was indicated that the patient was never doing "well" until the generator was turned off. Since that time he has not had any more seizures. The patient was referred for generator explant due to the pain. Attempts for additional information are in progress.
 
Event Description
It was reported on (b)(6) 2012 that the patient had his generator and lead explanted on (b)(6) 2012. The patient was not re-implanted. The explanted products were returned to the manufacturer on (b)(4) 2012 and product analysis is currently in progress and has not been completed at this time.
 
Event Description
Product analysis on the generator 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 generator performed according to functional specifications, and during the product analysis there were no anomalies found with the pulse generator. Pa on the lead was completed on (b)(6) 2013. Note that since the lead's electrode and anchor tether helix were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. However no obvious point of entrance was noted other than the identified tubing openings related to the explant procedure. No discontinuities were identified during the analysis. Other than typical wear and explant related observation, no anomalies were identified in the returned lead portion. A review of available programming history revealed no anomalies. The last available interrogation date was (b)(6) 2011. At that time the generator was enabled and diagnostics were within normal limits. Follow up performed with the treating surgeon was performed however he was unable to provide additional information as he indicated that the patient was evaluated by a neurologist and he was just asked to remove the device. Follow up performed with the last known treating neurologist was performed and it was indicated that they had not seen the patient since (b)(6) 2011. The pain and numbness had not been reported to his office; however he did indicate that the patient had been experiencing hoarseness since (b)(6) 2011. The neurologist did indicate that the patient had fallen off his bike in (b)(6) 2011, but he was unsure if this had contributed to the event. No other information was provided, and attempts to determine a more recent physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862854



Title: Re: Voice/Speech
Post by: dennis100 on October 01, 2017, 12:32:16 AM
Event Date 11/09/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that the patient was implanted on (b)(6) 2012, and that it took the patient three hours to come out from the anesthesia. The patient has had a problem with headaches since surgery and had "shots in the back of her neck" to treat the headaches. The neurologist believes that the headaches are due to the surgery. The patient was scheduled to have her vns turned on (b)(6) 2012. Good faith attempts for further information were made to the physician but were unsuccessful. The patient's implanted product information was also requested from the implanting hospital but they require patient consent in order to obtain this information and since the manufacturer does not have patient consent, the information cannot be obtained.
 
Event Description
Additional information was received on (b)(6) 2012, when the physician reported that the headaches and voice alteration were first observed on (b)(6) 2012. The physician noted that the device did not take his numbers entered, especially for the current. No interventions were taken or planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2860654



Title: Re: Voice/Speech
Post by: dennis100 on October 02, 2017, 12:21:32 AM
Model Number 103
Device Problem Unexpected therapeutic results
Event Date 08/03/2012
Event Type  Injury   
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2012. The clinic notes mention that the patient's most recent seizure was typical and associated with a longer postictal period. It was noted that the initial diagnosis of the patient's seizure disorder was year(s) ago and since diagnosis the disease has been worsening. The patient's settings were output=1ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=1. 5ma/magnet on time=60sec/magnet pulse width=500usec. The patient mentions that he wants his vns explanted and is having shortness of breath with stimulation. The patient's output current was then programmed to 0ma. Clinic notes dated (b)(6) 2012 mention that the patient is having difficulty breathing and difficulty breathing on exertion. The patient's most recent seizure was typical and associated with a longer postictal period. It was previously reported that the patient is experiencing shortness of breath in (b)(6) 2012 and was being seen by their physician for a dosing appointment. After the appointment the patient was reported to be doing great. The appointment went well and all symptoms had alleviated. The patient was set at a pulse width of 500usec and frequency of 30hz and had never been changed. The patient's settings were adjusted and the patient was doing great with no problems. The patient's voice alteration was better and he was much more comfortable. All symptoms alleviated with dosing changes. There have been no falls, etc. , that were related or could have contributed to the events. The patient's mother later reported that her son's device was programmed off on the week of (b)(6) due to severe voice alteration and shortness of breath. The patient's mother stated that the magnet mode was left on when they programmed the device off in (b)(6) 2012. The mother was unsure of the exact date of the disablement. She explained that both the dyspnea and the voice alteration occurred during stimulation of the device. The mother stated that adjusting the patient's settings was already attempted in august. She explained that after this adjustment, the patient did not get much better and that she feels the symptoms got worse. She did explain however, that this may have been due to him starting school shortly after. She denied any trauma or medications changes and stated that the patient's seizures have been about the same. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient continues to experience voice changes since vns explant. It was reported that the lead electrode were still implanted on the vagus nerve and that this may be contributing to the voice changes. No additional relevant information has been received to date.
 
Event Description
It was reported by the physician that it is unknown whether or not the remaining portions of the lead were simply aggravating or actually causing pain, and to what degree. The family has not decided whether or not to have surgery for removal. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
It was reported that the patient underwent vns system explant on (b)(6) 2013. It was reported that the devices were discarded by the explanting facility and will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2938421


Title: Re: Voice/Speech
Post by: dennis100 on October 03, 2017, 12:46:29 AM
Model Number 103
Event Date 10/05/2012
Event Type  Injury   
Event Description
The physician responded to attempts for more information but did not address the questions related to the increase in seizures. The patient had a generator replacement. Good faith attempt for the generator return have been unsuccessful to date.
 
Event Description
On (b)(6) 2012 clinic notes dated (b)(6) 2012 were received in reference to a vns patient. Review of the clinic notes revealed that the patient continues to have breakthrough seizures with altered awareness and some blurry vision but no convulsive activity. The breakthrough seizures were originally reported on (b)(6) 2012 which was the patient's last office visit prior to (b)(6) 2012. The patient was switched from depakote to topiramate due to weight gain while taking depakote. The medication change was said to have mixed results with the seizures being more frequent lasting 10 to 20 seconds. The patient was also having some difficulty finding words however the patient has not gained weight and was said to be feeling better on the topiramate. During the patient's last visit on (b)(6) 2012 the ifi (intensified follow up indicator) was observed when the vns device was checked and the patient wanted to have the device checked to see if the battery status of the generator had anything to do with the seizures. When the device was checked on (b)(6) 2012 the ifi was still showing yes and the battery capacity remaining was approximately 25% which is the same as it was when the vns device was checked on (b)(6) 2012. The physician felt that the seizures the patient was experiencing was either due to the medication change (depakote to topiramate) or due to the vns device battery being closed to end of service. The physician wanted to have the vns device replaced as it had worked very well for the patient in terms of seizure control. The patient has been referred for generator replacement surgery however surgery has not occurred to date. The patient's programming history available in the manufacturer's in-house database was reviewed and on (b)(6) 2012, the battery status read 'ok' indicating that it was not at end of service. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that product analysis was completed on the generator. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 724 volts as measured during completion of test parameter of the final electrical test, shows an ifi condition. The data in the diagaccumconsumed memory locations revealed that 77. 799% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901881



Title: Re: Voice/Speech
Post by: dennis100 on October 04, 2017, 12:41:44 AM
Model Number 102
Event Date 09/11/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013, this vns patient¿s caregiver poste a comment on social media. The caregiver reported that the patient has a vns. The system developed a fault: a fractured wire. Through ignorance of the patient¿s caregiver, the event gave the patient a very bad time for four months. Replacement took place, but the event stepped back the patient¿s progress.
 
Event Description
A vns treating physician reported to our country representative from (b)(6) they had a vns patient who was experiencing discomfort with stimulation, coughing with interrogation/programming, possible hoarseness and had his generator disabled. Since (b)(6) 2012, the date the patient had dental procedures and ct brain/facial bones, the patient has experienced the discomfort, making noises and coughing. Information received reported that the patient has experienced recent onset of +++ discomfort , making noises at regular intervals and holding his left side of his face/ head again at regular intervals. The patient in the last 3 - 4 weeks was making noticeable abnormal noises (possibly hoarseness) every 3 mins and also holding his hand to the left side of his head again at definite intervals. The patient is moderately to severely intellectually challenged and this intolerance is not uncommon behaviour. His father also reported that this was noticeable all night long when he picked him up and travelled with him to his neurology appointment. On (b)(6) 2012, vns was interrogated and settings were: 2. 0 ma, 30 hz, 500 pw, ot 30 secs, off t 3. 0, mag 2. 25ma, ot 30 secs, diagnostics system diagnostic test dcdc 2, normal mode diagnostic test 3, telemetry ok, lead ok. On interrogation the patient coughed profusely lasting > 60 secs. At previous visits this behaviour has not been seen. At the clinic session - their output current was lowered down to. 5ma steps to 0. 25ma. With the same outcome - +++ coughing, facial flushing and hand holding left side of head for >60 secs. They also attempted to reduce hz to 20 hz at. 25ma and same results. On turning their device off all symptoms subsided. Since their vns was programmed off the patient experienced an increase in the severity of their seizures with the loss of therapy. Since the patient does not live with the person who reported their seizures their md is not sure the information is reliable. X-rays were received for review. The electrodes are visualized but it is not possible to ascertain the placement in relationship to the cervical vertebrae due to limited views. A strain relief bend and loop are present but are difficult to assess due to the film angle. The loop appears to be in a "head-on" view. Two tie downs are noted securing the lead. It is noted the strain relief bend is not secured lateral to the anchor tether. A strain relief bend was present but there was no tie down present securing the bend, there was what appeared to be a loop with one tie down. A full loop cannot be confirmed based on the angle of the pictures. Another tie down was noted near the header of the generator therefore not placed per labeling. The strain relief should be adequate to allow for full neck movement to its maximum stretched positions. Most of the lead was visible and no obvious lead discontinuities were identified. Some lead is behind the generator and this portion cannot be assessed. The lead was intact at the connector pin but based on the angle of the generator header it could not be determined if the lead pin was fully inserted or not. The filter feedthroughs appeared intact. The patient had full revision surgery and it was noted on (b)(6) 2013 that they had a lead break in the potion that was apparently covered in the x-rays by the generator. Their explanted lead has been returned for analysis and is pending completion.
 
Manufacturer Narrative
X-rays were reviewed and were not able to access the header of the generator. Pin not being fully inserted was confirmed in product analysis. Findings.
 
Event Description
Product analysis was completed on the patient's explanted generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Lead analysis was completed. The lead was returned in five pieces. Two large and several small pieces. A lead break was not observed during this analysis. One set of setscrew marks was found near the end of the connector pin. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. The incision, puncture and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the pulse generator at one time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a lead discontinuity. When the patient's device was programmed off they had an increase in frequency and in severity of their seizures but still the same type of seizure. The patient was injuring himself during his seizures.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device malfunction 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=2976596


Title: Re: Voice/Speech
Post by: dennis100 on October 05, 2017, 12:50:33 AM
Model Number 103
Event Date 09/13/2011
Event Type  Malfunction   
Manufacturer Narrative
Device history records were reviewed. Review of manufacturing records confirmed all quality tests were passed for the generator prior to distribution.
 
Event Description
The patient had an appointment at the neurologist's office on (b)(6) 2013. The device was interrogated and his device was confirmed to still be off. Although, it was noted that the patient complains of trigeminal pain but the device was confirmed to be off. (the trigeminal pain is captured in mfg report number: 1644487-2004-00719. ) the notes did not mention the patient reporting his vns setting off anti-theft devices or any adverse events associated with the vns believed to be on. It is unclear why the patient believed his device was on as the notes did not indicate the patient reported this but the nurse did indicate that this is not to say that the patient did not mention it at the visit. She further went on to state that it looks like the device was turned off in (b)(6) 2011 and then turned back on (b)(6) 2012. This past year it was officially turned off, but she did not provide the specific date upon request. The nurse did not have additional information.
 
Event Description
It was reported that the patient came into the clinic recently and said that the vns is causing him severe voice alteration. It was confirmed that his voice was really hoarse such that he could barely speak. It was confirmed at the appointment that the device was turned off. The patient was told to see a throat specialist. This is an ongoing issue for the patient since 2013.
 
Event Description
The vns patient reported on (b)(6) 2013 that his device was turned off (b)(6) 2012 due to trigeminal neuralgia which was previously reported in mfg report number: 1644487-2004-00719. He reported since that time he has noticed that at times his voice changes randomly and he thinks his vns is still cycling at times. He says it occurs randomly. He also alleged that his vns sets off the anti-theft devices when he goes in and out of department stores. The patient then reported on (b)(6) 2013 that he had his device disabled about a year and a half ago. He again explained that he believes his device had turned itself back on as he has been experiencing hoarseness of voice and feeling the device cycling on and off since (b)(6) 2013. The patient explained that he does not feel the cycling all the time and that it only happens sometimes. When this does occur, the patient indicated that it can stimulate for a few hours up to a whole day. The patient firmly believes that an anti-theft device at a department store had spontaneously turned the device on. The patient has an appointment scheduled in (b)(6) 2013 with the currently treating physician. Follow-up with the physician's office on (b)(6) 2013 revealed that the patient had not reported these events to them. Review of the device history records for the vns generator revealed that all quality tests were passed prior to final release. Review of the patient's programming history revealed that on (b)(6) 2011 the patient's device was programmed off. The device was remained off on (b)(6) 2012. However, there is no subsequent programming history available after this date. In the (b)(6) 2012 notes when the patient was last seen, it was indicated that the patient believed his device had been turned off "due to solar flares" which the nurse was not sure what he meant by this. She is unsure if the device was actually turned off but they plan to check his vns device on his follow up appointment.
 
Event Description
On (b)(6) 2013, the patient reported that his vns has spontaneously started constantly cycling on again since (b)(6) 2013. Follow-up showed that the device was off. The patient was noted to have psychiatric co-morbidities. The physician did not recommend the device be removed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967448


Title: Re: Voice/Speech
Post by: dennis100 on October 06, 2017, 02:01:39 AM
Model Number 103
Event Date 11/23/2012
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2013 when the surgeon reported that a non-absorbable suture was used to tie-down the generator and lead to the fascia during implant. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
An implant card was received indicating that the patient underwent generator and lead replacement on (b)(6) 2013. The explanting facility reported that the explanted devices were discarded during the surgery and will not be returned for analysis.
 
Event Description
It was reported by the physician that the patient was in the office on (b)(6) 2012 stating she noticed the wire in her neck had moved and subsequently she started to experience hoarseness that was constant and having some coughing. The patient denied any trauma or falls. Per the physician, diagnostics were performed and were within normal limits. The physician indicated that it does appear that the wire has moved some and he states that he has sent the patient for an x-ray. The device was disabled and patient's hoarseness stopped immediately. He states that patient has not had any seizure event since he has been her physician. Additional information was then received from the patient's caregiver, who states that his wife's wire has moved and began to cause her discomfort with difficulty swallowing and eating. He stated that after the device was disabled, the patient started to have seizures again (below baseline) when she had been seizure free. Per the caregiver, he did not think that any trauma had occurred but he stated that she does hyperextend her neck in some intimate moments. Follow up was performed and it was indicated that the migration, pain, voice alterations, coughing, and dysphagia (feeling like neck was swollen) were all first noted on (b)(6) 2012. The increased seizures was noted on (b)(6) 2012 which was attributed to the device being disabled. The patient does not have a medical history of dysphagia pre-vns. A review of available programming history was performed and the last diagnostics from (b)(6) 2012 had results within normal limits. On (b)(6) 2013 information was obtained indicating that the patient was referred to a surgeon for possible revision surgery. Surgery has not occurred to date, and attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2944417


Title: Re: Voice/Speech
Post by: dennis100 on October 06, 2017, 09:48:37 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/09/2013
Event Type  Injury   
Event Description
Clinic notes were received for this patient's replacement surgery. The clinic notes stated that the patient had instructed an independent neurologist to reduce their settings, but no date or reason was provided. It was also noted that the patient would like his vns off, but there is no reason recorded. The patient reported that his voice changes and he has trouble swallowing when his device goes off when he is eating. It was also reported that the patient has an "atypical scar and placement of the vns stimulator and recurrent symptoms are provoked by stimulation" and this is the reason for referral for a vns revision. Additional information was received that the patient's settings are very low due to inability to tolerate high settings, believed to be due to the lead placement. No surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6850112


Title: Re: Voice/Speech
Post by: dennis100 on October 07, 2017, 01:47:26 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 08/10/2017
Event Type  Injury   
Event Description
It was reported that the patient was complaining of coughing and voice changes. X-rays were reviewed by the physician and no migration of the vns generator or lead was observed. Lead impedance was reported as good. The physician referred the patient for exploratory surgery of the generator and lead with a possible lead replacement. Follow up with the physician's office revealed that the patient felt that the device was continuously going off for about 15 minutes, during which she experienced voice alterations. The patient was instructed by the staff nurse to disable her vns using the magnet. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6860157


Title: Re: Voice/Speech
Post by: dennis100 on October 09, 2017, 01:08:43 AM
Model Number 102
Event Date 05/15/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had voice alterations and it becomes hard to breathe while exercising when the device is stimulating. It was also reported that a small firm 2mm elevated lump was noted, and that an increase in seizure frequency was also noticed and the patient cannot be certain how effective the vns is. Attempts to contact the physician have been unsuccessful to date. A battery life calculation was calculated and the vns generator was found at 6. 55 years remaining until end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2994918


Title: Re: Voice/Speech
Post by: dennis100 on October 12, 2017, 01:04:59 AM
Model Number 102
Event Type Injury
Event Description
The physician replied back to a fax with questions about the events on (b)(6) 2013. It was stated that no causal or contributory programming or medication changes preceded the trouble swallowing and the patient does not have a medical history of swallowing difficulties. The physician did not provide a clear response as to when the events were first observed or what the relationship is to vns. Additionally, the physician stated that she did not diagnose the sleep apnea. No other information was provided.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 state that the patient will think about a sleep study for apnea. Additionally, the notes state that the vagus nerve stimulator is being utilized and is causing a raspy voice. The patient has some trouble swallowing, where as he doses off he feels like he may suffocate. The vns reduced the patient's seizures by 75 - 100%. Follow up with the physician's nurse found that she did not believe that the sleep apnea was related to vns; however, she could not say for sure. The nurse stated that it sounded like the sleep study had not been ordered yet, unless it was ordered by someone else. She did not know when the apnea was first observed and could not provide any additional information on this. In addition, she stated that many patient's have raspy voice. No other information was provided on the voice alteration or swallowing difficulties. The nurse stated that the physician recently saw the patient for follow up and the physician said that the patient was doing fine and doesn't need to be seen again. Attempts were made for additional information; however, they were unsuccessful. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120083


Title: Re: Voice/Speech
Post by: dennis100 on October 12, 2017, 01:05:50 AM
Event Date 01/01/1996
Event Type Injury
Event Description
An article entitled ¿promising effect of vagal stimulation in (b)(6) patients with epilepsy¿ was received. The aim of this study was to evaluate the effect of vns on seizure frequency and to investigate patient satisfaction of and quality of life effects of vns treatment. (b)(4) patients were reviewed between 1996 and 2006. (b)(4) patients experienced a reduction in seizure frequency and (b)(4) of adults reported a positive effect on quality of life with a benefit on long-term treatment. Around (b)(4) also reported a positive effect on quality of life measure like copying, mood, self-confidence, and social abilities. In the children¿s group, (b)(4) report a positive effect on quality of everyday life for the child and the family, (b)(4) reported no change and (b)(4) a negative effect. The patients had mild side effects, expect for one case of vocal cord paralysis. Results also indicated that two children were reported as having suffered an increase in the frequency of seizures. Another patient had the vns removed due to mental side effects and experienced an increase in the frequency of seizures. Additional side effects included one case of infection, behavioral changes, hoarseness with stimulation, stimulation dependent dyspnea upon exertion, cosmetic complains, loss of singing ability, difficulties swallowing, difficulties speaking, and red, wide, or itchy scars. The authors suggest that the loss of singing ability could be due to vocal cord paralysis or hoarseness. This report captures the report of infection: mfr report #1644487-2013-01463. One increase in seizures is captured mfr report #1644487-2013-01462. Another increase in seizures is captured in mfr report #1644487-2013-01461. The increase in seizures with mental side effects is captured in mfr report #1644487-2013-01460. The vocal cord paralysis is captured in mfr report #1644487-2013-01459. The report of loss of ability to sing possibly due to vocal cord paralysis is captured in mfr report #1644487-2013-01464.

Manufacturer Narrative
Thygesen ks, sabers a. Promising effect of vagal stimulation in (b)(6) patients with epilepsy. Dan med j. 2013;60(3):a4597. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3121271


Title: Re: Voice/Speech
Post by: dennis100 on October 12, 2017, 01:06:43 AM
Event Date 01/01/2012
Event Type Injury
Event Description
Additional information was received that all of the reported adverse events (except for the cardiac event) were mild, temporary, and overall in line with the experience.

Manufacturer Narrative
Ryzi m, brazdil m, novak z, chrastina j, oslejskova h, rektor i, et al. Long-term vagus nerve stimulation in children with focal epilepsy. Acta neurol scand. 2012. Http://www. Ncbi. Nlm. Nih. Gov/pubmed/22994298.

Event Description
An article entitled ¿long-term vagus nerve stimulation in children with focal epilepsy¿ was received. The article reviewed one and two year efficacies of 15 patients implanted with a therapy system. Of the 15 patients, 7 were responders at one year after implant, nine were responders at two years after implant, and nine were responders at five years after implant. Initial settings were provided. The output current was increased in two week increments of 0. 25 ma to a target intensity of 01. 50 ma to 2. 0 ma depending on efficacy and the presence of side effects. Rapid cycles (on time: 3. 0 seconds, off time: 1. 8 minutes and on time: 7 seconds, off time: 18 seconds) was used in all patients who were classified as non-responder at one year. Medications were kept unchanged during the first six months. The article concluded that vagus nerve stimulation is an effective method of treating children with refractory focal epilepsy. It led to a substantial decrease in the number and duration of urgent hospitalizations. The article indicated that one patient experienced severe adverse effects requiring explant of the device. The patient experienced repetitive attacks of cardiac asystolia, sometimes associated with syncope at the time when the device was switched on. The syncopes started after more than one year of stimulation. The asystole was strictly related to the on status of the device and was not related to patient seizures. ¿ this was provided by video-eeg monitoring. The patient did not response to vns; therefore, the output current was not adjusted. The discontinuation of vns led to the complete cessation of these symptoms. The cardiological investigations performed on this patient both pre-operatively and post-operatively (during the off times) revealed no abnormalities. Other severe adverse effects were not observed. The explant due to cardiac events is captured in mfr report #1644487-2013-01439. Urgent hospitalizations were also reported for nine patients in the post-operative period. This was defined as hospitalization because of an increase in seizure frequency with a change or adjustment in the long-term aed treatment or because of an adverse event, a complication of the epilepsy itself, or an aed treatment that lead to any permanent therapeutic treatments. This report captures the urgent hospitalization for an increase in seizure frequency for patient 2 of 9. Additional reports are captured in mfr report #1644487-2013-01490, mfr report #1644487-2013-01493, mfr report #1644487-2013-01494, mfr report # 1644487-2013-01495, mfr report #1644487-2013-01496, mfr report #1644487-2013-01497, mfr report #1644487-2013-01498, mfr report #1644487-2013-01499 the article also noted that cough, hoarseness, and mild dysphagia were observed in 12 of the 15 patients reviewed. In none of these patient¿s was the severe effect a reason for discontinuation of vns, and the effect resolved completed by the next visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122180


Title: Re: Voice/Speech
Post by: dennis100 on October 12, 2017, 01:07:37 AM
Model Number 102
Event Date 05/08/2007
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the physician stated the patient¿s device has been disabled again and that it is going to be permanent in nature.

Manufacturer Narrative

Event Description
On (b)(4) 2013, it was reported that for a while the vns was efficacious for the patient but when the settings were increased, the patient began experiencing abdominal cramping which became so bad the patient wanted the device disabled. After several years, the patient had transferred care and the new physician decided to start the patient back up with vns the past summer to try vns again. He had gradually ramped the patient up, but the patient¿s abdominal issues came back, as well as voice alteration with stimulation. The physician stated that now that they have tried their best with vns for this patient, he is going to turn the patient¿s device off as the side effects are too much for the patient to handle. It was indicated the device is functioning properly. The physician believes that the abdominal issues occur with stimulation and that for the most part, the event had subsided when the patient¿s device had previously been disabled. The patient had not experienced this event pre-vns. The only interventions being planned at this time is device disablement. Previously in 2007 it was reported that the patient experienced constant abdominal cramping, and that this resolved when the output current was decreased to 0. 25ma. The physician reported that the patient has had this symptom "to varying degrees in the past", but the patient "feels the abdominal cramps have been worse since vns. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3137212


Title: Re: Voice/Speech
Post by: dennis100 on October 12, 2017, 01:08:37 AM
Model Number 103
Event Date 05/18/2011
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient had been experiencing coughing, increased seizures, and hoarseness on (b)(6) 2011. The patient felt the cough and hoarseness with stimulation. The physician was unsure whether the seizures increasing were due to the vns. They were all resolved on (b)(6) 2011. Attempts for additional information have been made but no further information has been received to date.

Event Description
Additional information received on (b)(6) 2013 when it was reported that the physician did not believe that the patient¿s increase in seizures is related to vns therapy. No interventions were taken. The patient's settings on (b)(6) 2012 were stated to be: output current - 1. 5 ma, frequency ¿ 30 hz, pulse width ¿ 500 microseconds, on-time 30 seconds, off-time ¿ 5 minutes, magnet output current ¿ 1. 75 ma, pulse width - 500 microseconds, on-time ¿ 60 seconds, battery end of service status - ok. No interventions were taken or planned to preclude a serious injury. The physician stated that the relationship of the increase in seizure to pre-vns baseline levels is unknown. The patient does not have multiple seizure types. Causal or contributory programming changes, medication changes, or other external factors did not precede the onset of the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3031252


Title: Re: Voice/Speech
Post by: dennis100 on October 13, 2017, 12:29:00 AM
Model Number 102
Event Date 03/21/2013
Event Type Malfunction
Event Description
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. "what was the original intended procedure?removal of vagal stimulator. Device #1is this a laboratory device or laboratory test?no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3123518


Title: Re: Voice/Speech
Post by: dennis100 on October 13, 2017, 12:30:15 AM
Model Number 103
Event Date 01/01/2013
Event Type Malfunction
Event Description
It was initially reported that the patient had generator replacement on (b)(6) 2013 prophylactically. Clinic notes dated (b)(6) 2012, a month prior to surgery, indicated that the patient's seizures have decreased. A referral for generator replacement was performed on this date. The generator was returned to the manufacturer for analysis, and the return product form from the hospital reported the reason for replacement as end of service (battery depletion). However a nurse at the neurologist's office reported on (b)(6) 2013 that the reason for generator replacement was that the device was "not working properly". No further details were provided at that time. Attempts for additional information for clarification for the reason for replacement have been unsuccessful to date. Product analysis of the explanted generator revealed that there were no adverse functional, mechanical, or visual issues identified with the returned generator. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. The results of diagnostic testing indicated that the battery status indicated ifi=yes which appears to be appropriate based on downloaded device data; generator performed according to functional specifications.

Manufacturer Narrative
Review of manufacturing history records performed. Review of the generator manufacturing history records confirmed all quality tests were passed prior to distribution.

Event Description
Additional information was received from the physician in response to a faxed request from the manufacturer for information. Per the physician, the (b)(6) increase in seizure reported over the phone was the patient experiencing seizure four times per month. After medication changes, the patient experienced two seizures per month. At the (b)(6) visit, the patient's mother reported general tonic clonic seizures at school on (b)(6), which was unusual. Also, the patient experienced voice effect of vns. This was the only change after replacement as of february 5 visit. No causal or contributory programming or medication changes preceded the onset of the decreased perception to stimulation. No patient manipulation or trauma is believed to have caused or contributed to the decreased perception to stimulation. The patient's settings as of (b)(6) 2010 were provided and it was noted that the patient had 2 seizures a month at that time.

Event Description
Per the physician¿s response that was previously reported, the patient was seen after revision surgery on (b)(6) 2013. The patient experienced brief behavior arrest, facial twitch for a few seconds, no gtc, and was back to early summer 2012 baseline.

Manufacturer Narrative
Describe event or problem: previously submitted emdr inadvertently omitted additional information regarding the patient¿s seizures from the incoming communication. This report is being submitted to correct this information.

Event Description
Additional information was received from the treating neurologist¿s office indicating that a device malfunction was not suspected ¿other than battery strength. ¿ it was initially indicated that the device was ¿not working properly¿ because the patient¿s caregiver had noted less impact on vocalization during stimulation on-times and a slight increase in seizures. The patient¿s average seizure frequency per month in (b)(6) 2012 was about two to four seizures, per mother. The battery indicator was reported to be about greater than 4/5 depleted. Previously in (b)(6) 2012, it was indicated that the patient¿s seizures had decreased from four to two per month, but the relationship of the seizure frequency during that time to pre-vns baseline level was unknown. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118336


Title: Re: Voice/Speech
Post by: dennis100 on October 16, 2017, 12:45:57 AM
Model Number 302-20
Event Date 07/04/2013
Event Type Malfunction
Event Description
A battery life calculation was performed which showed 4. 59 years remaining until eri=yes. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(4) 2013 it was reported that the patient has high impedance. The generator was disabled due to the high impedance. The patient¿s device has never been higher than 1. 25 ma due to significant voice changes and the family believes it has not made any difference to his seizures. The patient plays football, so there is a possibility that the device may have been knocked at some point. The physician stated that prior to this week; it was last checked a year ago. The patient was referred to a surgeon for further investigation and possible removal of the vns. It was stated that x-rays will not be taken. The patient is going to be observed to see if the device being off has an effect on the patient¿s seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3239162


Title: Re: Voice/Speech
Post by: dennis100 on October 16, 2017, 12:46:43 AM
Model Number 105
Event Date 06/26/2013
Event Type Injury
Event Description
On (b)(6) 2013 information was received from the reporter stating that the vns patient was aspirating liquids along with experiencing hoarseness since implant. It was reported that the patient was recently implanted and that the device had not yet been programmed on. It was reported that no device diagnostic tests have been performed since the device is off. The patient has been referred to neurosurgeon for follow-up. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3257441


Title: Re: Voice/Speech
Post by: dennis100 on October 16, 2017, 12:47:59 AM
Model Number 102
Event Date 05/21/2013
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
It was reported that the patient had generator replacement surgery on (b)(6) 2015. The lead was not replaced. The hospital discarded the explanted generator. Therefore, analysis is unable to be performed. The hospital reported that the reason for replacement was end of service. The implant card reported that the reason for replacement was battery depletion (end of service). The lead impedance was okay after generator replacement.

Event Description
A letter by the treating physician dated (b)(6) 2014 reported that the patient¿s battery reached end of life in (b)(6) 2014. Since that time, the patient¿s depression has increased with worsening dysfunction. Surgical intervention is likely but has not occurred to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(4) 2013 it was reported that high impedance was seen during diagnostics on the patient¿s vns that day; output=limit/lead impedance=high/eri=yes. The impedance value was not noted by the physician. It was stated that the patient continues to still have voice alteration with stimulation on-times and there hasn¿t been a change in efficacy at this time. The patient¿s settings were noted to be output=2. 25ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=3min. The patient did not want to be disabled at this time and the physician decided to not disable since the patient is not having any adverse issues or change in efficacy. There has been no known cause for the high lead impedance and it was stated that the patient would be referred for surgery. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The physician later stated that the patient presented on (b)(6) 2013 with high impedance during diagnostics but when she did another diagnostics, the high impedance was not observed. The patient¿s battery is low and will therefore be replaced. No further information was provided by the physician. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(6) 2013 the physician reported that she believes the dcdc was 4 when diagnostics were performed. She stated that when diagnostics were performed a second time however, the high lead impedance was not replicated. She stated that the settings of the battery were lowered due to concern that the battery would run out before he can have surgery. The patient was referred for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3166186


Title: Re: Voice/Speech
Post by: dennis100 on October 17, 2017, 01:08:35 AM
Model Number 102
Event Date 03/01/2012
Event Type Malfunction
Event Description
The patient reported that she believes there may be an issue with her vns, because she was seizure free for eight years and is no longer seizure free. The patient is going to a pain management doctor and specialist for a nerve block, so there is no revision planned at this time.

Manufacturer Narrative

Event Description
The patient had a follow up visit on (b)(6) 2013 and it was decided that the vns device would be turned off for about two months to analyze if there was any change in seizures. If the seizures worsen, revision surgery would be considered. No surgery has been performed to date.

Event Description
Additional information was received indicating that the vns patient¿s device was found to be programmed on during an office visit on (b)(6) 2014. At these settings, the patient was not able to perceive stimulation.

Event Description
Clinic notes dated (b)(6) 2013, indicate the patient has pain in the left neck at the vns region. The patient feels the device is turning on when she touches it and thinks the lead in her neck is touching a muscle, thereby hurting her and sending pain into the ear, sensitivity in gums on jaw, and pain in shoulder and neck muscles. Per the notes, the vns "dysfunctioned" due to high output now with pain and with positional changes. The vns output current was disabled to 0 ma. Follow up was performed to confirm if a device malfunction is suspected; however, no clear answer was provided. The patient will be seen again to determine if a revision or explant surgery should be performed. Surgery has not occurred to date. The patient has reported several instances of pain since (b)(6) 2012; however, no interventions were taken or planned to preclude a serious injury at the time and device malfunction had not been alleged. Below is a summary of the previous allegations made concerning this patient: it was reported on (b)(6) 2012 that a patient could only feel stimulation if her head was turned to the left, and therefore, the patient believes it only works when her head is turned in that direction. The manufacturer¿s representative was present at the appointment and reported that the patient was demanding a full revision. The manufacturer¿s representative performed normal mode and system diagnostics with the patient in multiple positions, and the dcdc value was consistently 4 and 2, respectively. The patient¿s settings on this visit were 2. 5 ma, 25 hz, 250 microseconds, 21 seconds on, 0. 3 minutes off with magnet settings of 2. 75 ma, 250 microseconds, 60 seconds on. The patient reported that the erratic stimulation feeling first began in march when the output current was increased. No recent trauma or accidents were reported. Additional information was received on (b)(6) 2012 from the patient indicating that she awoke that morning with pain around the generator and described it as ¿feeling like a tearing sensation. ¿ the patient reported that she ¿started checking it out¿ and it hurt when she pushed on ¿certain areas. ¿ she also reported that the magnet stimulation did not feel as strong. Later on (b)(6) 2012, the patient reported to the manufacturer¿s representative that the magnet appeared weak. By turning the head to the left, the magnet feels weaker than before. The patient reported that she ¿just had a medium aura,¿ however there was no indication that this was an increase in auras or unusual for the patient. The manufacturer¿s representative attended the patient¿s appointment on (b)(6) 2012. The patient presented with her husband, and she reported that "she woke up one morning and had all this pain at the generator site when she pushed on the generator. " it was clarified that the patient slept on her left side that night on the couch, and she only had such pain the day after she slept on her left side with her left arm up. In addition, she admitted that the pain was due to her pushing on the generator. The patient is reportedly doing really well, and she hasn't had many seizures at all. She complained of voice alterations at the appointment, but the physician indicated that the patient was making her voice change on her own and it did not coincide with stimulation. The patient said it happened with magnet mode stimulation. The patient did seem to have a "jolt" of voice alteration about 60 seconds after she swiped the magnet which did not coincide with her swipe and settings. Diagnostics are fine, and everything is reportedly okay. The physician believes that the patient wants attention, and so she is asking for a full revision. However, she was not referred for surgery at this time. The physician said that he would refer her for surgery if she wants it though, because he likes to please his patients and this patient is persistent. No issues are suspected with the magnet strength, and no follow up was provided on the patient¿s auras. No issues were suspected by the physician. Additional information was received from the patient indicating that she was experiencing pain at the electrode site all day. The patient puts oil on it to alleviate the pain. The patient indicated that if she presses on the lead wire, it hurts even more, and the pain travels into the lower part of the left jaw. The more she turned her head or uses the magnet, the more the site hurts. Additionally, she indicated that she could not turn her head to the left to ¿get the strongest results¿ during vns stimulation and noted swelling in the neck. The patient has reportedly noticed the last couple of days that when she was icing her shoulder (believed to be unrelated) with the ice pack also touching her neck that the swelling had mostly gone down at the electrode site. Follow up with the tc for clarification revealed that the pain at the vns device site is related to operational context as she pushed on the device. The reported events are related to her mental conditions. Her seizures are not above pre-vns seizure frequency. No additional information could be provided as the patient has not been evaluated by the physician. Furthermore, the patient reported in (b)(6) 2013 that she felt the lead had migrated. Follow up with the md revealed that he does not believe lead has moved. Additionally, the ae¿s events that the patient previously reported have all resolved through device setting changes (not to preclude a serious injury). Diagnostics were reported to be within normal limits. The physician started dropping the output current and on time and it is not bothering her as much. The erratic stimulation has since resolved. Additional information was received from the patient on (b)(6) 2013 reporting that for about six months she has been feeling ¿some poking¿ in the electrode area with it hurting at times. During the prior six weeks when the patient went without a seizure, her neck ¿dramatically loosened up. ¿ after using the magnet, her neck tightened up again with pain on the left side of the neck. She has been lifting her head up when lying down to stretch the muscle and loosen up the neck for about the last two months. The patient also indicated that she was still having a problem with the strength feeling stronger when her neck is turned to the left. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3312781


Title: Re: Voice/Speech
Post by: dennis100 on October 18, 2017, 12:47:53 AM
Model Number 63850
Event Date 06/17/2013
Event Type Injury
Event Description
I had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3305360


Title: Re: Voice/Speech
Post by: dennis100 on October 20, 2017, 12:29:57 AM
Model Number 102
Device Problem Communication or transmission issue
Event Date 08/19/2013
Event Type Malfunction
Event Description
On (b)(6) 2013 a call was received from the patient while in the physician¿s office. He stated that the physician was trying to turn off his generator but that they continued receiving communication errors on the handheld. The patient said that he had stepped out of the physician¿s office because he did not have an appointment but wanted to figure out what was occurring with the programming system prior to being seen again. The patient stated the programming system was currently charging in the office. The patient was told how to check the 9v battery status and to ensure that the handheld was not plugged into the wall, that there was no emi in the room, and that all the cord connections were checked. The patient he was going to get an extra 9v battery for the physician and said that he would call back with any further information. Patient was having generator turned off due to voice alteration he has always experienced, but because he is now involved in singing and public speaking and does not want that to become an impediment. Patient also stated he never really experienced efficacy. Both of those events captured in another file. No further details discussed. A battery life calculation indicates there is an estimated 6. 04 years until eri = yes. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Attempts have been made for additional information; however, they have been unsuccessful.

Event Description
It was reported that the patient¿s generator could be interrogated and programmed since the originally reported failure to program. No additional pertinent information has been received to date.

Manufacturer Narrative
Review of programming history and device manufacturing records. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3353595


Title: Re: Voice/Speech
Post by: dennis100 on October 21, 2017, 01:01:36 AM
Model Number 302-20
Event Date 01/01/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported via the nurse that the patient had been experiencing voice alteration for a year, but that it had not been discussed since diagnostics were all ok and the patient had stated that the voice alteration was more of a constant rather than occurring with stimulation. The issue first began in (b)(6) 2012. The patient's settings were decreased from output current of 1. 75 to 1. 5ma and magnet output current of 2 to 1. 75ma. Per the notes, the system test resulted in dcdc 2 and normal mode was a dcdc 3. The patient was also referred to an ear nose - throat doctor (ent), dr. (b)(6), who did tests and found that there was extra weakness in her voice when the stimulation was present. The patient was seen again (b)(6) 2012, during which the settings were decreased again (output current from 1. 5 to 1. 25ma, magnet from 1. 75 to 1. 5ma). The patient reported doing a bit better. System diagnostics resulted in dcdc 2, normal mode was dcdc 3. The patient was seen (b)(6) 2012, and settings were decreased again (output current from 1. 25 to 1ma, magnet from 1. 5 to 1. 25ma). System diagnostics resulted in dcdc 1 and normal mode diagnostics resulted in dcdc 3. (b)(6) 2013, the patient was seen and settings were not changed. This time, system diagnostics resulted in dcdc 0. In (b)(6) 2013, system diagnostics were dcdc 0 again, and patient reported the dysphonia was better and her ability to speak was ok. The patient was last seen (b)(6) 2013 and was still improving. System diagnostics resulted in dcdc 1. The ent took x-rays and it had seemed that everything was intact. However, due to the dcdc of 0, the physician stated she was considering having the patient's device replaced. It was noted that along with the decrease in settings, the patient began having an increase in seizures. However, the physician was unsure if the increased seizure frequency was related to vns or not. The increase in seizures was not above pre-vns baseline leves. The patient's device was disabled and the patient is still experiencing chest and neck discomfort. Additional follow up indicated the patient was seen again on (b)(6) 2013 and was having more seizures that were not above pre-vns baseline levels. There were no contributory external factors, physical status, medications, etc. No recent changes were made. The patient was presented still experiencing voice dypshonia. Last time the patient was in, her voice was better for about 2-3 weeks, but now it is worse and she has discomfort in the chest area up to the electrodes that feels like it travels throughout the vns system. The patient has reportedly always complained of pain around the electrode site the last year or two but it has become more pronounced. The patient has been monitored for a year and the site has been watching the dcdc code drop from 3 to 0; however, the diagnostics never showed low or high. The patient mentioned that it "doesn't come on and of like it used to" in a way that the stimulation does not feel the same. The dysphonia is what brought the site to notice this initially. The patient was feeling the dysphonia/stimulation in one specific area in the neck which used to make the patient's voice low but now yesterday, the patient presented with her voice really high pitched. The physician said at that point that there is "something going on" and questioned if there could be an issue with the vns. Initially, they thought it could have been related to non-neurological events, co-morbid conditions. However, they all resolved and now they have determined it's related to vns. They do not want the patient to go through this anymore, so they have referred her for surgery and she will likely have a full revision. The office event sent the patient for psychiatric evaluations to rule psychiatric reasons out and ruled the events to be related to vns for the last year. Additionally during a routine clinic visit for general follow-up when she was being seen every 3-6 months, the office sent the patient to an ent immediately to perform swallowing tests. The ent determined there was weakening of the vocal cord (not paralysis) from implant of vns but when vns is stimulation, they attribute the dysphonia to the stimulation. The ent told neurology that the dysphonia is probably related to the stimulation. The patient was diagnosed in the beginning of 2012 or mid-2012. The patient did not want to stop vns because she had such a good benefit with vns. The dysphonia got better for 2-3 weeks then kicked back. The patient relies heavily on the magnet for seizures/auras, and she began feeling a lot more of voice change along with pain/discomfort along the vns system (chest/neck areas). No x-rays being taken at this time as they are referring the patient for surgery irregardless. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3347530


Title: Re: Voice/Speech
Post by: dennis100 on October 22, 2017, 01:31:22 AM
Model Number 103
Event Date 04/29/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient requested to have the vns generator and lead removed because he no longer wants it and has hoarseness. Attempts have been made for additional information; however, no additional information has been received. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406152


Title: Re: Voice/Speech
Post by: dennis100 on October 22, 2017, 01:32:20 AM
Model Number 102
Event Date 10/19/2011
Event Type Injury
Manufacturer Narrative

Event Description
Initially, it was reported that the patient has been hoarse since vns surgery. It was reported that the patient had moved to a different state since implant and didn't have a physician to check the vns system. The patient was seen by a new physician at which time it was reported that the patient's voice was "horrid" and that she does not speak at a regular tone of voice. The new physician increased the patient's output current from 0. 5ma to 0. 75ma. It was later reported on (b)(6) 2013 that the patient recently underwent surgery with an ent for vocal cord issues. It was reported that the vocal cord issues were not related to vns, but that the surgery resolved the issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3403604


Title: Re: Voice/Speech
Post by: dennis100 on October 23, 2017, 12:58:57 AM
Model Number 102
Device Problem Device inoperable
Event Date 10/15/2012
Event Type Malfunction
Event Description
The patient inquired on how to get his device replaced due to end of service (eos) condition of his battery because he has had another two nervous breakdowns, like the ones he had in 2013 when he was initially told that it was at eos. He also commented that he still had intermittent choking, voice issues and left ear pain, but it is not consistently happening with stimulation like it did before. No surgical intervention has occurred to date.

Event Description
Clinic notes were received for the patient's referral for generator replacement. The notes were handwritten and indicate that the patient "reports various side effects relative to vns system. Don't know if the system is actually working or not. " no surgical intervention has occurred to date.

Event Description
On (b)(6) 2013, the patient reported that he had a nervous breakdown about three months ago and started having "manic" behavior about one year ago. It was determined that his vns device had died by another physician. Attempts will be made for additional information. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462850


Title: Re: Voice/Speech
Post by: dennis100 on October 23, 2017, 12:59:42 AM
Model Number 103
Event Date 08/12/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the device settings were reduced in efforts to relieve the patient's dysphagia, hoareness and tiredness following an increase in device settings. It was reported that following the decrease in settings the patient experienced an increase in seizures and that the dysphagia and hoarseness also increased. It was reported that the device was programmed off on (b)(6) 2013 due to the worsened symptoms. It was reported that the patient was analyzed in 2010 by a otorhinolaryngologist due to the dysphagia and no abnormalities were seen. No abnormalities were found when the patient was sent to speech therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479717


Title: Re: Voice/Speech
Post by: dennis100 on October 27, 2017, 07:24:45 AM
Model Number 102
Device Problem Slippage of device or device component
Event Date 05/01/2007
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Age at time of event, date of event, corrected data: the initial report inadvertently reported the approximate date incorrectly. The settings were programmed down in (b)(6) 2007.

Event Description
The patient's programmed settings were lowered in (b)(6) 2007.

Event Description
It was reported that the patient wanted to undergo device explant. The patient reported that he was able to feel the device move when he exercized and he experienced voice alteration. It was reported that the device has been programmed off due to lack of efficacy for a while. Clinic notes dated (b)(6) 2014 note that the surgeon will be contacted to remove the vns. No surgical intervention has been performed to date.

Event Description
Additional information was received that the patient still would like to have vns explanted. The patient reported bruising at the generator site area in the chest since a recent fall (not related to vns) and has difficulty lying on his side after the fall. He states that his particular indication made efficacy difficult. No surgical intervention has occurred to date.

Event Description
The implanting surgeon reported that the generator was secured to the fascia at implant with a non-absorbable suture.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3698296


Title: Re: Voice/Speech
Post by: dennis100 on October 27, 2017, 07:26:05 AM
Model Number 101
Event Date 01/01/2013
Event Type Injury
Event Description
Notes dated (b)(6) 2013 indicated that the patient may have had a seizure on (b)(6) 2013. The device was interrogated at 1. 75/20/130/30/5/1. 75/30. The impedance was ok (dcdc=3), the output status was ok, and the battery was noted to be functioning well. Notes dated (b)(6) 2013 indicated that the patient presented with a 2 year history of voice changes and hoarseness. The patient did not experienced any hoarseness following vns implant, except when it fires. A flexible videostroboscopy was performed with mild atrophy and supraglottic contraction but otherwise normal results. The event was determined to be muscle tension dysphonia for which the patient was referred for speech therapy. Clinic notes dated (b)(6) 2013 stated that the patient felt that her device was no longer working. The patient had three grandma seizures during the year. Prior to that, the patient had not had any seizures in 12 years. The patient also noted that her voice felt weak at times and thought the events might be related. A flexible laryngoscopy was performed: bot, vallecula, and piriform sinuses were clear and normal. Both true vocal cords showed good mobility, but there was possible slight bowing with a 1 mm gap. Moderate arytenoid erythema and mild edema were present. It was reported that the patient has possible mild age related atrophy and mild laryngitis contributing to her voice changes. The patient was referred for generator revision. The vns generator replacement was performed on (b)(6) 2014. The explanted vns device was discarded and therefore cannot be returned. Attempts are being made for additional information; however, no other information has been provided.

Event Description
It was reported that the generator battery was dying and the patient experienced more seizures. The physician reported that the patient is doing much better since generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606821


Title: Re: Voice/Speech
Post by: dennis100 on October 30, 2017, 02:23:09 AM
Model Number 103
Event Date 04/29/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s seizures initially decreased following vns implant surgery but recently had an increase in seizures. It is unknown if the increase in seizure was at or above pre-vns baseline levels. The patient was also experiencing coughing, dysphagia, and voice alteration. The patient was referred to an ent physician to determine if his symptoms were due to vocal cord paralysis. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3828122


Title: Re: Voice/Speech
Post by: dennis100 on October 30, 2017, 02:23:56 AM
Model Number 103
Event Date 04/25/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s device was fine and that there were no issues. The patient¿s device settings were increased and the increased settings caused throat pain and voice alteration. The patient could not tolerate the higher settings. The settings were decreased and the patient was doing fine.

Event Description
It was reported that the physician was having issues interrogating the patient¿s device. The physician stated that the patient likely left his office visit on (b)(6) 2014 without having his device settings adjusted. The patient was scheduled to have his device settings lowered because he was having difficulty tolerating stimulation. It was reported that the physician had issues interrogating the patient¿s device in the past. The wand battery was replaced and confirmed to be functioning normally. The programming system was then able to interrogate a demo device. It was reported that the nurse always had the programming system was plugged in while interrogating patients.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3827885


Title: Re: Voice/Speech
Post by: dennis100 on November 02, 2017, 01:20:40 AM
Model Number 302-20
Device Problem High impedance
Event Date 05/06/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s device did not show any issues in (b)(6) 2014. Despite the high impedance observation, the patient reportedly continued to receive efficacy from the device. The patient was experiencing voice alterations and throat tickling/tightening sensations similar to those prior to high impedance.

Event Description
It was reported that device diagnostics resulted in high impedance (5500 ohms). The device was not programmed off and there was no known trauma. X-rays were sent to manufacturer for review. Review of x-rays identified a suspect area near the lead pin that may be the cause of the high impedance. No further relevant information has been received to date. No surgical intervention has been performed to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, a suspect area of the lead was seen by the lead pin that could have caused the high impedance. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Further information was received from a nurse, indicating that the patient underwent a full replacement surgery on (b)(6) 2015. The lead was replaced due to high impedance and the generator was prophylactically replaced. It was reported that the explanted devices will not be returned to the manufacturer. Therefore, no device analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3846200


Title: Re: Voice/Speech
Post by: dennis100 on November 02, 2017, 01:21:24 AM
Model Number 105
Event Date 05/12/2014
Event Type Malfunction
Event Description
It was reported by the patient that her device settings had changed on their own from 5 to 10. It is unclear which device settings she was referring to. The patient was experiencing erratic stimulation, pain with stimulation, coughing and voice alteration. The pain was reported to be unbearable at times. The pain occurred at her electrode site and travelled up the left side of her head and down to her shoulder. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854286


Title: Re: Voice/Speech
Post by: dennis100 on November 08, 2017, 01:51:44 AM
Event Type Malfunction
Event Description
An abstract titled ¿complications of vagus nerve stimulation for epilepsy in children: how can we do better?¿ was received which included patient adverse events and product problems. There were 14 cases involving infections, two cases involving infections that were managed with aggressive antibiotics treatment and did not require device explant, and four cases that involved vocal cord dysfunction, lead fracture, or battery malfunction. This manufacturer report involves the case of either vocal cord dysfunction, lead fracture or battery malfunction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4258213


Title: Re: Voice/Speech
Post by: dennis100 on November 11, 2017, 03:00:12 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 08/18/2017
Event Type Injury
Event Description
It was reported that the patient has been complaining of voice alterations due to stimulation. The patient was seen in clinic and the physician agreed that he does have on-time voice ¿warbling. ¿ his impedance was around 3000 ohms. The neurologist had attempted to adjust settings to help with the voice alteration but the voice alteration persisted. Diagnostics were also within normal limits. Since this voice alteration was still persisting, the neurologist decided to refer the patient for imaging to the surgeon to asses the lead placement (possible close to vocal cord) as he thought maybe there was some type of irritation causing this voice alteration as he thought it was uncommon it didn't resolve with settings adjustment and wanted to avoid any possible damage in the future. Also since the patient is young they wanted to go ahead and replace now just in case. The patient underwent lead replacement on (b)(6) 2017. The explanted lead has not been received for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6952922


Title: Re: Voice/Speech
Post by: dennis100 on November 12, 2017, 03:21:02 AM
Model Number 103
Event Date 01/05/2015
Event Type Injury
Event Description
Additional information was received that the patient underwent a "voice surgery" in (b)(6) 2015 for the patient who needed her vns generator adjusted. However, the exact date and reason for this surgery are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported that the patient was scheduled for generator repositioning surgery. The reason for the surgery is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4440451


Title: Re: Voice/Speech
Post by: dennis100 on November 14, 2017, 02:15:36 AM
Model Number 103
Event Date 01/16/2015
Event Type Malfunction
Event Description
It was reported that the vns patient was experiencing voice alteration during stimulation on-times from her device. The patient taped her magnet over the generator to temporarily disable the device but was unsuccessful. The patient continued to perceive stimulation on-times from her device despite having the magnet taped over the generator. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4502739


Title: Re: Voice/Speech
Post by: dennis100 on November 14, 2017, 02:16:40 AM
Model Number 100
Event Date 02/18/1999
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns device was turned off since 2010 due to extreme dysphagia with vns stimulation. It was previously reported that there were a variety of setting changes to help improve the reported event. After decreased settings at the appointment prior (b)(6) 2008, the voice alteration and swallowing improved. However even at low settings, the patient had dysphagia. Good faith attempts to obtain additional information were unsuccessful.

Event Description
Additional information was received that the device was turned off in 2010 due to perceived lack of efficacy for the patient's epilepsy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521869


Title: Re: Voice/Speech
Post by: dennis100 on November 15, 2017, 02:42:27 AM
Model Number 104
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative
Pt ag: age at time of event: the initial report inadvertently reported the age incorrectly. Date of event: the initial report inadvertently reported the event date incorrectly. The physician reported the patient developed the congestive heart failure over the past few years.

Manufacturer Narrative

Event Description
Follow-up with the physician revealed that the device was disabled on (b)(6) 2015. The physician stated it was unknown whether it will be re-enabled at a future date. The patient reports that dyspnea decreased after disabling. The patient stated they feel better overall after disabling. The device was turned off to prevent serious injury related to the report of tachycardia.

Event Description
It was reported that the vns patient was experiencing the following events which the physician believed were related to vns: congestive heart failure, stomach ulcers, tachycardia not associated with stimulation, dyspnea not associated with stimulation, and voice alteration. The physician elected not to disable the patient¿s device due to its effectiveness in reducing the patient¿s suicide attempts and depressive episodes. The physician noted that vns is not the source of these issues but believed that may be contributing to the patient¿s events. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623006


Title: Re: Voice/Speech
Post by: dennis100 on November 16, 2017, 02:50:52 AM
Model Number 103
Event Date 02/01/2014
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Patient age; corrected data: the previously submitted mdr inadvertently provided an incorrect patient age. Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Event description; corrected data: the previously submitted mdr inadvertently did not include all of the information available regarding the event. Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong explant date of the device.

Event Description
Information was received indicating that the patient¿s device was explanted on (b)(6) 2015 due to pain. The pain was first observed in (b)(6) 2014 in the throat and at the electrode site. The physician decided to disable the device in (b)(6) 2014 for patient comfort. The physician later attempted to program the patient¿s device back on and the patient was unable to tolerate the minimal device settings. The patient reported a burning sensation at the site of implantation, which recurred every five minutes during stimulation on-times. She also complained of dysphonia and tension of the platysma muscle. The patient¿s seizure frequency remained the same. Mri was performed with the purpose of finding an epileptogenic lesion (which was actually found in that study). It was indicated that programming changes/ medication changes/ other external factors did not cause or contribute to the pain. The patient had no prior history of this particular pain prior to vns. Product analysis was completed for the generator. There were no performance or any other type of adverse conditions found with the generator. Product analysis was completed for the lead. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description
It was reported that the vns patient underwent surgery to explant her device on (b)(6) 2015 due to painful stimulation. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577017


Title: Re: Voice/Speech
Post by: dennis100 on November 18, 2017, 02:22:23 AM
Model Number 103
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the patient's generator was explanted in (b)(6) 2014 due to lack of efficacy. Further information was later obtained that despite the physician trying to adjust settings, the patient has secondary effects of thoracic pain, tachycardia and increased hoarseness which were also reasons for the patient's explant of the device. These issues were worsened with stimulation. The explanted generator and lead was returned for analysis on (b)(6) 2015 and product analysis for the generator was completed and approved on (b)(6) 2015. In the analysis 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. In addition, 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 pulse generator. Product analysis for the lead was completed and approved on (b)(6) 2015. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4665087


Title: Re: Voice/Speech
Post by: dennis100 on November 18, 2017, 02:24:43 AM
Model Number 102
Device Problems Migration of device or device component; Unexpected therapeutic results
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient was not tolerating the system and would undergo explant. The patient reported that the device was programmed off in 2008 due to lack of efficacy. The patient reported that the generator site is currently tender, sore and itches and she can see the shape of the device under her skin. The patient also indicated that she can feel the lead electrode pushing up against the skin like "it wants to poke out". The patient reported that the seizures are pre-vns baseline frequency. The patient indicated that she wants the device explanted. The patient underwent generator and lead explanted due to pain and hoarseness. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

Manufacturer Narrative
Corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.

Event Description
Analysis of the generator was completed on 04/15/2015. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specification. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/14/2015. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4674518


Title: Re: Voice/Speech
Post by: dennis100 on November 22, 2017, 03:41:46 AM
Model Number 102
Event Date 07/11/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient's device settings were adjusted which led to five apnea episodes secondary to vocal cord weakness. The notes indicate that these issues had been "taken care of. " follow-up revealed that the patient had a history of sleep apnea and that the patient had a sleep apnea device. The patient underwent a sleep study in 2009 and was diagnosed with mild apnea.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4824543


Title: Re: Voice/Speech
Post by: dennis100 on November 24, 2017, 04:09:03 AM
Model Number 300-20
Device Problems Improper or incorrect procedure or method; Device operates differently than expected Event Date 06/25/2015
Event Type Malfunction
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that the high impedance was first observed on (b)(6) 2015 and was not observed prior to that. Patient was referred for lead revision and prophylactic generator replacement but no surgical interventions have occurred to date.

Event Description
It was reported that the patient¿s device was turned off for mri on (b)(6) 2015, and turned back on on (b)(6) 2015. At this time the pulse width was increased from 250 to 500. Around 5:30 am on(b)(6) 2015, the patient could not speak or stick out her tongue, and appeared to be in much pain. Device was turned off again and it helped for a while but the issues did not resolve. System diagnostics show result of high impedance. It was also mentioned that the patient recently underwent craniotomy 3 days prior to (b)(6) 2015.

Event Description
Additional information was received that the patient underwent surgery on (b)(6) 2015. It was reported that the patient's implanted generator and lead were not removed as the surgeon did not want to create a new scar. Instead, the surgeon implanted a new vns generator and lead on the right side of the patient. The lead was implanted on the right vagal nerve. The patient and family agreed with the surgeon and therefore the old devices were not touched. The surgeon was informed of the cardiac risks of implanting vns system on the right side. The neurologist was also made aware of the two systems implanted in patient and that the system on the left will show high impedance as this was not corrected. Neither the patient nor the surgeon at this time feels that it is necessary to remove the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4907360


Title: Re: Voice/Speech
Post by: dennis100 on November 25, 2017, 08:41:01 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 05/07/2015
Event Type Injury
Event Description
It was reported that the patient's device was turned off due to experiencing voice alteration. The patient was referred to an ent. It was reported that the patient has not had improvement with the hoarse sounding voice.

Event Description
It was reported by a patient that the healing process wasn't going well after vns surgery. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The patient reports that his voice is improving, but his throat is still sore. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5016010


Title: Re: Voice/Speech
Post by: dennis100 on November 26, 2017, 03:16:10 AM
Model Number 103
Device Problem Battery issue
Event Date 06/01/2015
Event Type Injury
Event Description
The explanted device was discarded after surgery and will not be returned for analysis.

Event Description
It was reported that the patient had a generator replacement on (b)(6) 2015. Information obtained on (b)(6) 2015 that the patient was seen on (b)(6) 2015. It was noted that the patient was last seen in (b)(6) 2014 and seizures were well controlled. However, over the last 3-4 weeks she has noticed more frequent seizures. For most of her seizures, she usually has aura, which was described as tingling sensation in hands, followed by difficulties with getting the words out, lasting about a minute. Over the last 3-4 weeks, she had two episodes of generalized tonic-clonic seizures without any warning. The battery was interrogated and showed that the battery is low with ifi-yes. Over the last few months, she has also been complaining of worsening headache with dizziness spells. Attempts for further relevant information have been made but have been unsuccessful to date. The explant generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021879


Title: Re: Voice/Speech
Post by: dennis100 on November 26, 2017, 03:16:54 AM
Model


Title: Re: Voice/Speech
Post by: dennis100 on November 27, 2017, 02:57:15 AM
Model Number 105
Device Problem No Information
Event Date 07/09/2015
Event Type Injury
Event Description
Additional information was received that the patient is still fighting (b)(6) infection and that the physician recommended explant of the lead, which was not previously removed. The initial infection was reported to have started about a week after implant.

Event Description
Per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015.

Manufacturer Narrative
Suspect device udi: (b)(4).

Manufacturer Narrative
Describe event or problem, corrected data: per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015. This information was inadvertently left out of the previously submitted emdrs.

Event Description
It was reported that the patient acquired an infection, which was first observed by the physician on (b)(6) 2015. The infection was reported to have started in the chest incision and followed the lead up to the neck site. Patient underwent explant of vns system on (b)(6) 2015 as planned. No patient involvement was suspected. A culture was taken but the results were not available. Review of manufacturing records confirmed that both the generator and lead were sterilized prior to distribution.

Event Description
An image was received showing flushing and puffiness around the generator pocket incision site. Some puffiness was also visible around the neck incision site. Notes from the surgery were also received stating that the patient developed some redness near the incision and some drainage that appears to be infected. The surgeon found some serosanguineous fluid , which was cultured and then removed the generator from pocket. The surgeon also removed the lead and was able to dissect the lead but noted that there was significant amount of scarring and inflammation in the sternoclaoimastoid muscle.

Event Description
Patient underwent lead removal surgery on (b)(6) 2016 and the surgeon removed the two electrode sets and the anchor tether. During the surgery, the surgeon noted that there was evidence of left vagus nerve injury that resulted in hoarseness and coughing. The surgeon's impression was that someone pulled the lead thinking that the electrodes will unwrap themselves. Per the surgeon, the patient had seen a ent a few weeks ago and received an implant in the left vocal cord to get the vagus nerve to more approximate normal location.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5001435


Title: Re: Voice/Speech
Post by: dennis100 on November 29, 2017, 01:44:41 AM
Model Number 101
Device Problem No Information
Event Date 10/18/2001
Event Type Injury
Event Description
It was reported that the patient had some psychiatric issues and that the patient wanted the device turned off and explanted shortly after it was turned on. Patient's vns device was explanted in 2004 but the exact reason is unknown. Attempts for additional relevant information were unsuccessful to date.

Event Description
Additional information was received from the nurse that the patient experienced choking, difficulty talking and sleeping due to vns stimulation since (b)(6) 2001. As a result, the vns was disabled on (b)(6) 2003. Patient mentioned that the vns never worked for patient in terms of seizures control. Patient underwent left temporal lobe surgery in 2003 and did not need the vns for seizures. Therefore the vns was removed 6 years later in 2009. The nurse did not think there was any psychiatric issues with the patient and is not aware of it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5098934


Title: Re: Voice/Speech
Post by: dennis100 on December 05, 2017, 02:26:32 AM
Model Number 102R
Event Date 10/29/2015
Event Type Malfunction
Event Description
Patient underwent generator replacement due to battery depletion on (b)(6) 2016. The explanted generator has not been received to date despite multiple attempts.

Manufacturer Narrative

Event Description
It was reported that the physician was unable to interrogate the patient's generator on (b)(6) 2015 with two different programming systems. The physician was not concerned about the function of the programming systems as they have been successful in interrogating other vns patients till then. The patient's device is not suspected to be at end of service and patient is only returning in (b)(6) 2016 for the next appointment. Additional information was received that the programming system used for patient's device was also used the next day for a different patient and programming went successfully and no issues with the programming system were suspected. Patient was last seen on (b)(6) 2015 but her vns device was not interrogated at that time. However, notes mention that the patient gets hoarse when it the stimulation cycle is on. The previous provided did not interrogate the vns device and so the last noted settings available were from 2010 with output current as 1. 75 ma, 30 sec on and 5 minutes off. Patient was reported to be having increased seizures, which were likely above pre-vns baseline. Patient's seizures were aborted with the magnet swipe but were not doing so anymore. It is unknown if patient is able to feel vns stimulation but patient does not feel the hoarseness anymore either. Patient's last seizure was reported to be provoked by missed medication. It is unknown if the increased seizures might be related to patient's non-compliance to medication. Patient has also gained weight (~40 lbs) since implant and the nurse was unable to palpate the generator. The presence of fatty tissue in the chest and the implant depth might also be a contributory factor. Additional relevant information was not received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5243069


Title: Re: Voice/Speech
Post by: dennis100 on December 07, 2017, 02:33:42 AM
Model Number 106
Device Problem No Information
Event Date 11/02/2015
Event Type Injury
Event Description
It was reported that a patient, recently implanted with vns system, had pain and hoarseness. The patient was stating that it was tight and hurting a lot. It was reported that the patient was seen by a nurse and her physician, where she received antibiotics because the incision looked red. But the patient's throat was sore and her voice was still hoarse. It was reported by the nurse that the device had not been turned on yet, so the pain and soreness was likely a result of the surgery. Further information received indicates that the patient was again seen in clinic and she was doing well; the pain has stopped and her wound was dry. The patient's voice has been settled. It was reported that the device is now turned on. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Additional manufacturer narrative and/or corrected data, corrected data: (b)(4). The suspect device udi was inadvertently not provided in the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5260052


Title: Re: Voice/Speech
Post by: dennis100 on December 07, 2017, 02:35:22 AM
Device Problem No Known Device Problem
Event Date 07/13/2015
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2015 it was reported that the patient's vns is scheduled for removal on (b)(6) 2015. The patient was bothered by stimulation and had device turned off in (b)(6) 2015. It was noted that the patient's depression has not worsened and he is having good results with ect. The nurse reported that the patient's vns had been disabled on (b)(6) 2015 and is scheduled to be explanted due to dysphonia and dyspnea. She also reported that the patient's vns had been implanted on (b)(6) 2013 and that the patient's (b)(6). The patient underwent explant of the vns on (b)(6) 2015 but the product cannot be returned for product analysis as the site discards explants. Good faith attempts for further information from the physician were unsuccessful. Attempts were also made for the patient's product information but no further information was received.

Event Description
Clinic notes dated (b)(6) 2016 indicate that the patient is considering replacement of the vns device as she is now having more frequent seizures without the vns. Although surgery is likely, it has not occurred to date.

Event Description
Clinic notes dated (b)(6) 2016 indicate that the patient's vns was disabled several months prior and that the patient is considering replacement of the vns device. Therefore, the patient has not yet undergone explant of the vns system.

Manufacturer Narrative
Describe event or problem: if explanted, give date (mo/day/yr), corrected data: inadvertently did not include this information on follow-up report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5297223


Title: Re: Voice/Speech
Post by: dennis100 on December 07, 2017, 02:36:08 AM
Event Type Injury
Manufacturer Narrative

Event Description
An article titled "laryngeal motility alteration: a missing link between sleep apnea and vagus nerve stimulation for epilepsy" was published in 2015 which included adverse events involving 23 vns patients. 23 consecutive patients with medically refractory epilepsy underwent out-of-center sleep testing before and after vns implantation. 8 eligible subjects underwent endoscopic laryngeal examination post-vns implantation. Manufacturer report # 1644487-2015-06755 involves the patient 1 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06757 involves the patient 2 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06758 involves the patient 3 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06759 involves the patient 4 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06760 involves the patient 5 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06761 involves the patient 6 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06763 involves the patient 7 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06764 involves the patient 8 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06765 involves the patient 9 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06766 involves the patient 10 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06767 involves the patient 11 who had laryngeal motility alteration and a new-onset mild/moderate sleep breathing disorder. Manufacturer report # 1644487-2015-06768 involves the patient 12 who had laryngeal motility alteration and a worsening of sleep breathing disorder when already being diagnosed with obstructive sleep apnea. Manufacturer report # 1644487-2015-06769 involves the patient 13 who had laryngeal motility alteration and a worsening of sleep breathing disorder when already being diagnosed with obstructive sleep apnea. Manufacturer report # 1644487-2015-06770 involves the patient 14 who had a new onset of nocturnal seizures after developing obstructive sleep apnea, after vns implantation. The patient had also a laryngeal pattern with vocal cord adduction during vns stimulation, and laryngeal motility alteration. Manufacturer report # 1644487-2015-06771 involves the patient 15 who had a new onset of nocturnal seizures after developing obstructive sleep apnea, after vns implantation. The patient had also a laryngeal pattern with vocal cord adduction during vns stimulation, and laryngeal motility alteration. Manufacturer report # 1644487-2015-06772 involves the patient 16 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06773 involves the patient 17 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06774 involves the patient 18 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06775 involves the patient 19 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06776 involves the patient 20 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06778 involves the patient 21 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06779 involves the patient 22 who had laryngeal motility alteration. Manufacturer report # 1644487-2015-06756 involves the patient 23 who had laryngeal motility alteration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5306558


Title: Re: Voice/Speech
Post by: dennis100 on December 07, 2017, 02:37:03 AM
Model Number 304-20
Event Date 09/30/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported via clinic notes that patient had vns implanted on (b)(6) 2015 and has since been having complaints of hoarseness and choking. The surgeon did a scope and said the vocal cord was abnormal. The patient was reportedly drinking and eating some, but not all foods due to the dysphagia. Additional information was received that the left vocal cord was only partially paralyzed (paresis), and is improving. Both the paresis and dysphagia are thought to be due to both the implant surgery and vns stimulation. The patient is continually being monitored for these issues, and they are reportedly improving. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5270442


Title: Re: Voice/Speech
Post by: dennis100 on December 07, 2017, 02:37:55 AM
Model Number 103
Device Problem No Information
Event Date 01/01/2013
Event Type Injury
Event Description
A battery life calculation was performed which showed the generator had approximately 2 years remaining until a near end of service (neos) = yes condition. The programming history database was reviewed and showed the generator was working as intended through (b)(6) 2012. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported the vns generator was disabled as the patient experienced a lack of efficacy and due to intolerability of the magnet as the patient experienced brief apnea and voice alteration. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5312949


Title: Re: Voice/Speech
Post by: dennis100 on December 08, 2017, 03:38:18 AM
Model Number 303-20
Device Problem No Known Device Problem
Event Date 12/18/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient is experiencing vocal cord paralysis. The vocal cord paralysis began right after implant surgery. From the patient¿s outpatient clinic visit two weeks following surgery the patient had hoarseness and coughing and still has this issue. Later on, during several visits, the hoarseness was stated as still being an issue, but mostly related to stimulation. In (b)(6) 2017, the patient was seeing a medical specialist because of hyperventilation: left vocal cord paralysis. No intervention is being taken for the vocal cord paralysis. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7046173


Title: Re: Voice/Speech
Post by: dennis100 on December 08, 2017, 03:39:16 AM
Model Number 103
Event Date 02/04/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
Patient underwent generator replacement surgery on (b)(6) 2016 and the reason for the surgery was marked as prophylactic. The explanted generator was reported to have been discarded. Prior to the surgery, the patient's generator was able to be interrogated successfully. As the physician is confident that their programming system is working properly, it is believed that the presence of electromagnetic interference might have contributed to the initial interrogation failure.

Event Description
It was reported that the physician was unable to interrogate patient's generator. The physician took steps to troubleshoot her own programming system and is confident that this programming system is working properly. The physician was unable to interrogate this patient's device on (b)(6) 2016 but was able to interrogate another patient successfully on (b)(6) 2016. The physician mentioned that the patient uses his magnet "heavily" and believes this generator is at end of service (pulse disabled stage). Patient was last seen in (b)(6) 2015 and the generator was able to be interrogated at that time. The magnet was swiped during the clinic visit to test if the generator was working but patient did not experience voice alteration. The voice alteration was also not consistent. Patient previously used to experience voce alteration associated with stimulation on times. Attempts for additional relevant information have not been successful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5466522


Title: Re: Voice/Speech
Post by: dennis100 on December 08, 2017, 03:40:24 AM
Model Number 103
Event Date 01/22/2016
Event Type Injury
Manufacturer Narrative

Event Description
The physician reported that the facial droop, tachycardia, and voice alteration are not related to vns. The physician reported that voice alteration was not noted. The physician also reported that since the patient relates that when the device is off there are no voice changes, the device was programmed off; however, magnet mode stimulation was left on. The physician indicated it is unclear when and why the patient's complaints originated.

Event Description
The patient continues to complain of vocal issues. She indicated that she was seen by an ent. The patient indicated that the ent believed the wire may have gotten tugged during a neck surgery where a steel plate was placed in the patient's neck that may be causing the patient's issues. The patient also reported that she is experiencing vocal dystonia and gastroparesis. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The patient reported that she has facial droop which she resolves with her magnet. The patient also reported that she taped the magnet over the generator to disable device stimulation and she was no longer experiencing tachycardia. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The physician¿s office indicated that the patient has been treated for dystonia for a while at another clinic and it was not believed to be related to vns. The notes found that the patient was seen on (b)(6) 2016 and the vns was functioning as intended. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5470661


Title: Re: Voice/Speech
Post by: dennis100 on December 08, 2017, 03:41:17 AM
Model Number 302-20
Device Problem Mechanical issue
Event Date 09/01/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient reported that he was experiencing pain in his neck and hoarseness at times several months after generator replacement. Diagnostic tests showed that the vns device was functioning normally and the settings were reduced. It was noted that the prior to vns implant the patient had suffered from a gun shot wound and the surgeon believed that the current pain was associated with scar tissue that developed after the gun shot wound. The patient had benefited from vns therapy and the surgeon believed that the scar tissue in the neck needed to be removed. The patient later underwent surgery where the surgeon found that the insulated tubing of the lead was abraded. The surgeon assessed that the broken tubing caused the patient's discomfort. The vns lead was then replaced and the existing generator was left implanted. The explanted lead was then discarded following surgery therefore product analysis cannot be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7063234


Title: Re: Voice/Speech
Post by: dennis100 on December 08, 2017, 11:50:45 PM
Model Number 105
Device Problem No Known Device Problem
Event Date 03/06/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the vns did work lightly for the patient in the first month. Patient reported that his seizure frequency and severity was increasing and that the patient is very tired and drained after the seizures (especially the silent ones). The patient mentioned that the seizures came so suddenly that he could not swipe the magnet in time. Patient also experienced voice alteration, which affected the patient's singing. As a result, it contributed to patient's depression and anxiety. The device was then disabled by the neurologist. Patient mentioned that the vns stress enhanced the seizures. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7043556


Title: Re: Voice/Speech
Post by: dennis100 on December 09, 2017, 01:51:07 AM
Model Number 304-20
Device Problems High impedance; No code available
Event Date 06/01/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
A high impedance event was observed for the patient's device within the programming history. Generator and system diagnostic tests were performed, which indicated high impedance results. The physician noted that the patient had some discomfort with the device and had raspy voice when talking due to vns stimulation. The physician concluded that the vns is still working because each stimulation of the vns made patient's voice raspy. The settings were adjusted from 1. 0 ma to 0. 875 ma with the other setting parameters remaining the same. The patient tolerated well and had no further of raspy voice. Patient isn't experiencing any side effects or seizures specific to the high impedance. No known surgical interventions have occurred to date to address the high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7035996


Title: Re: Voice/Speech
Post by: dennis100 on December 11, 2017, 03:13:29 AM
Model Number 103
Event Date 03/26/2013
Event Type Injury
Event Description
Follow-up from the physician's office revealed that the cause of the lack of efficacy was a result of the previous vns causing pain during stimulation. Discomfort was experienced by the patient prior to the surgery to remove vns. The physician indicated it was unknown if the cause of the discomfort was due to the presence of the device or migration. A portion of an operative note from the explant surgery was provided which did not provide a cause for the migration of the device. It was unknown whether the patient experienced the voice alteration and vibration also when the device was turned on. The physician was unable to clarify the cause of the reported vibration of the device. It was provided that the surgery to remove the device was to relieve patient discomfort and was not to prevent a serious injury.

Event Description
It was previously reported that a patient's device was removed due to lack of efficacy. Clinic notes were received (b)(6) 2016 in relationship to vns re-implant surgery. The notes provided additional information that the vns was previously believed to be non-effective and the patient then wanted the device to be explanted due to discomfort from the device as well as migration. The patient also reported that she experienced voice alteration and vibration of the device, and the device was referred for explant due to this as well. The generator and lead had been explanted on (b)(6) 2013 and were returned to the manufacturer for analysis. The generator output signal was monitored and results showed no signs of variation in the generator's output signal demonstrating that the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. An electrical evaluation showed that the generator performed according to functional specifications. The downloaded generator data revealed that 34. 825% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Some of the lead assembly, including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5433986


Title: Re: Voice/Speech
Post by: dennis100 on December 11, 2017, 03:14:41 AM
Model Number 105
Event Date 01/20/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
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. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The battery, 3. 008 volts, shows an ifi=no condition. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. In addition, the in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions). There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
High impedance was observed for the patient's device with >10000 ohms. Patient did not have a robotic voice since (b)(6) 2016 that patient normally has with vns stimulation. Patient also experienced pain at the generator site. The device was disabled as a result on (b)(6) 2016. During surgery on (b)(6) 2016, the surgeon chose to prophylactically replace the generator for a newer model. Upon replacing the generator, the surgeon subsequently got 3200 ohms as the impedance with the new generator connected to the old lead. Generator diagnostics with the test resistor indicated 4000 ohms. The physician was attempted to manipulate the lead during case to check the integrity of the lead and receive impedance around 3200 ohms repeatedly. The surgeon also tried to manipulate the patient's neck to see if the initial high impedance could be due to a micro fracture, but the impedance was again within normal limits. As a result, the lead was not replaced. Both the generator and lead were implanted for more than 2 years. The explanted generator was received for analysis on 2/5/2016. Analysis is underway but has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5448815


Title: Re: Voice/Speech
Post by: dennis100 on December 11, 2017, 03:15:32 AM
Model Number 304-20
Event Date 01/01/2016
Event Type Injury
Event Description
It was reported that the patient was scheduled for a revision surgery due to painful stimulation. The patient underwent a lead revision surgery on (b)(6) 2016. Diagnostics showed the device to be functioning properly with impedance value of 4050ohms and not near end of service. The explanted lead was discarded and therefore cannot be returned for product analysis. The physician reported that the patient had been experiencing neck pain and a hoarse voice. Clinic notes from the (b)(6) 2016 visit report that the patient feels that it never quite worked right as she was having neck pain and a hoarse voice every time the device stimulated. She feels like a wire is irritating her. It is palpable subcutaneous. The physician sent her for a soft tissue neck x-ray which showed that the device appears to be in a reasonably good orientation near where it should be.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5451007


Title: Re: Voice/Speech
Post by: dennis100 on December 12, 2017, 01:58:01 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/17/2015
Event Type Injury
Event Description
It was reported that a vns patient had an increase in seizures since the last vns settings were adjusted. The increase in seizures was above pre-vns baseline level. Further information was received indicating that the patient was suffering encephalopathy with multifocal seizures. It was reported that before the increase in seizures, the patient could stay up to 10 days without seizures. However, during that period, the patient was having an adverse event: voice alteration. In order to reduce that, it was decided on (b)(6) 2015 to modify the vns settings, moving from 30sec on time / 1. 8min off time (duty cycle of 25%) to 7sec on time / 1. 1min off time (duty cycle of 15%). This resulted later in an increase in seizures. The impedance value was at 1750 ohms and end of service no. The patient was seen again in clinic on (b)(6) 2016 and the device settings were programmed back to the initial settings (increasing the duty cycle). It was reported that the patient will be seen again in clinic, in (b)(6) 2016 for a follow-up. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

Manufacturer Narrative
Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Event description; corrected data: the previously submitted mdr inadvertently provided an incorrect event description. Relevant tests/laboratory data, including dates; corrected data: the previously submitted mdr inadvertently provided incorrect data, including dates.

Event Description
It was reported that a vns patient had an increase in seizures since the last vns settings were adjusted. The increase in seizures was above pre-vns baseline level. Further information was received indicating that the patient was suffering encephalopathy with multifocal seizures. It was reported that before the increase in seizures, the patient could stay up to 10 days without seizures. However, during that period, the patient was having an adverse event: voice alteration. In order to reduce that, it was decided on (b)(6) 2015 to change the vns settings. Those settings were modified on (b)(6) 2015, moving from 30sec on time / 1. 8min off time (duty cycle of 25%) to 14sec on time / 1. 8min off time (duty cycle of 15%). This resulted later in an increase in seizures. The impedance value was at 1750 ohms and end of service no. The patient was seen in clinic on (b)(6) 2016 and the device settings were programmed back to the initial settings (increasing the duty cycle). Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Additional information was received indicating that the patient was seen again in clinic, on (b)(6) 2016, and he reported that his seizures have improved: now he could stay up to 10 days without seizures. The physician decided to not change the device settings again. No further information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5412470


Title: Re: Voice/Speech
Post by: dennis100 on December 12, 2017, 01:58:50 AM
Model Number 105
Event Date 01/07/2016
Event Type Injury
Manufacturer Narrative

Event Description
The lead and generator were explanted on (b)(6) 2016. The explanted devices were reported to have been discarded by the explanting facility.

Event Description
Clinic notes were received for a vns patient, who is being referred for explant surgery due to the vns causing voice alteration and pain in the throat with stimulation. The patient was using the magnet to disable the device but the physician had turned it off at the patient's request. It was noted that the physician could not increase the vns levels due to the side effects from the vns. No known surgery has occurred to-date. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5419824


Title: Re: Voice/Speech
Post by: dennis100 on December 15, 2017, 02:07:46 AM
Model Number 103
Event Date 10/05/2011
Event Type Injury
Event Description
Clinic notes were received for review. Clinic notes dated (b)(6) 2013 indicate that the patient has obstructive sleep apnea and the frequency on the vns was changed from 25hz to 20hz "since the patient has osa and higher frequencies may at times worsen the apnea episodes and therefore increase the frequency of seizures. " the notes also mention that the patient's mother does not feel that the vns has been helpful at all. Clinic notes dated (b)(6) 2012 state that the patient's output and magnet current were increased to 1. 25/30/500/30/5/. 758/60/500 and the patient showed some signs of throat discomfort. Due to the discomfort, the patient's signal frequency and pulse width were decreased to 25hz/250usec and the patient was observed to tolerate this settings. The patient noted some vocal hoarseness with this but did not appear to have any throat discomfort. Clinic notes dated (b)(6) 2011 indicate that the patient was last seen on (b)(6) 2011 and the vns settings were increased at that visit and the patient had success with abortion of seizures or shortening of seizure by swiping the vns magnet. However, at this visit, the patient's seizures have become harder and longer, however, the frequency of his seizures have decreased slightly. The patient however has had his keppra xr changed to a generic form. This occurred on saturday, and on sunday, he had a 2-minute seizure, and on monday, he also had a 2 minute seizure. The patient was continued on the same vagus nerve stimulator settings. It was noted that the patient is tolerating these settings; however, his seizures have gotten somewhat harder and longer although their frequency has slightly improved. On (b)(6) 2016 the physician's office reported that the patient's cpap was reported to have been used prior to the placement of the vns. It was reported that keppra was also increased after the increase in seizures. The seizures were not indicated in the notes to have been related to the vns. The lack of efficacy was also stated to likely be due to the patient's history and disease state and that he was not a responder to the therapy. The physician later reported that diagnostics were normal at 2713ohms and that the patient's change in seizure pattern was an increased in intensity and length but an improvement in frequency. The patient was changed from a cpap to autopap on (b)(6) 2011. The physician believes the obstructive sleep apnea is unrelated to vns. The change in seizure pattern is partially related to vns as the patient also had been changed to generic form of keppra xr during this time. There was no contributory programming changes. The physician believes that the vns improved the frequency of the patient's seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5483828


Title: Re: Voice/Speech
Post by: dennis100 on December 18, 2017, 01:52:32 AM
Model Number 103
Event Date 04/05/2016
Event Type Injury
Event Description
It was reported that the patient's devices were explanted less than a month from initial implant on (b)(6) 2016 due to infection. Patient is on a 6-8 week antibiotic therapy to clear infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Manufacturer Narrative
(b)(4).

Event Description
Additional information was received that the patient is experiencing hoarseness and coughing which began shortly after the explant surgery. It was initially thought to be bronchitis, but they now believe it to be related to the explant surgery. The patient has been referred to see an ent to assess the adverse events. Patient's hoarseness and coughing had not resolved and patient was provided medication for bronchitis and reflux. Patient saw a pulmonologist on (b)(6) 2016 who stated that the patient developed acute bronchitis. The cause of the bronchitis is unknown. Patient had a pre-existing diagnosis of asthma prior to implant surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5659628


Title: Re: Voice/Speech
Post by: dennis100 on December 24, 2017, 02:45:32 AM
Model Number 102
Event Type Injury
Event Description
It was reported that the vns patient has new small seizures and balance disorders in addition to his usual seizures. No end of service flag was seen during interrogation. A battery life calculation using the available programming history showed approximately 4. 6 years left until near end of service is yes. Additional information was received from the physician with all data regarding the patient's follow-up records since the vns implantation in (b)(6) 2012: on the visit 1 in (b)(6) 2012, the device was programmed at 0. 25ma output current - 250¿sec pulse width - 20hz frequency - 30sec on time and 5min off time. No special adverse event was and everything was ok. On the visit 2 in (b)(6) 2013, the patient was stable. He has spent 1 week without seizure (after vns activation) which is rare. He had some seizures during the (b)(6) period. The output current was increased at 0. 5ma. On the visit 3 in (b)(6) 2013, it was found that the patient's seizures increased a little in 2 months. The parents reported dysphonia and small cough but the patient's mood had improved well. The output current was increased to 0. 75ma without any adverse event. No cough was noted. On the visit 4, it was reported that the patient spent 9 days without seizures. The vns stimulation was well tolerated but some episode of cough was reported. The output current was increased to 1ma. System diagnostics returned impedance results within normal limits. On the visit 5, some episode of fever was reported (but not more than 38°c). The cause was unknown but, as reported by the physician, this is a known event to encephalopathic patients with lennox gastaut syndrome. No infection occurred. The output current was increased at 1. 25ma. On the visit 6 in (b)(6) 2013, it was reported an increases in seizures but not intense. It was reported that this could be related to patient's emotions. The output current was increased at 1. 5ma. On the visit 7 in (b)(6) 2013, frequent seizures were noted but not intense. It was reported by the caregivers that the vns magnet was more used because it stops immediately 80-90% of seizures. The output current was modified to 1. 75ma and the frequency was increased to 30hz. On the visit 8 in (b)(6) 2013, the patient seizures frequency was stable and not intense. No voice alteration and cough were reported. The output current was increased at 2ma and the pulse width to 500¿sec. On the visit 9 in (b)(6) 2013, it was noted that the patient mood and behavior were improved well. But it was reported that the patient had one big seizure and fall. Small tonic seizures were noted too. The output current was changed to 2. 25ma. On the visit 10 in (b)(6) 2014, the physician reported that a positive evolution of the situation was noted. A small cough was reported. System diagnostics returned impedance results within normal limits. The duty cycle was changed by modifying the off time from 5min to 3min. On the visit 11 in (b)(6) 2015, a progressive increase in seizures was noted during the past 7 months. No change in medications was performed. It was reported by the physician that this could probably due to the modification of duty cycle (from 5 to 3min off time). The physician decided to change back the duty cycle to the initial settings. System diagnostics returned impedance results within normal limits. On the visit 12 in (b)(6) 2015, it was reported that since the duty cycle was modified back to initial settings, an improvement was noted; seizure reduction was noted. It was reported that the patient was still sensible to emotions. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. On the visit 13 in (b)(6) 2016, it was reported that since (b)(6) 2015 the patient had more seizures. It was reported that on (b)(6) 2016, the patient had a big seizure and fall. That day, he had pallor, muscle spasms, brief respiratory arrest and wound on eyebrow which was treated by antibiotics. It was reported that the patient had later 2 other big unusual seizures: they were generalized tonic chronic seizures. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. The output current was changed to 2. 75ma. On the visit 14, on (b)(6) 2016, the patient was seen for a follow-up of lennox gastaut syndrome. Eeg was ok with some improvement. It was reported that the patient had ambulation difficulties and fall; he could not stay up for a long time. An increase of hemiparesis was reported. Nevertheless, patient's seizures reduction was noted. The vns stimulation was well tolerated. System diagnostics returned impedance results within normal limits and the near end of service flag was no. It was reported that the last vns parameters were at 2. 5ma output current ¿ 30hz frequency ¿ 500¿sec pulse width ¿ 30sec on time ¿ 5min off time. 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=5789779


Title: Re: Voice/Speech
Post by: dennis100 on December 26, 2017, 02:54:29 AM
Model Number 302-20
Event Date 08/03/2011
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the pt's physician that high impedance had been detected on the pt's generator. The physician stated that since recently being implanted, the pt had felt the device stimulating through coughing, sore throat, gagging, and voice alterations. These effects had improved some recently. At the time of surgery, the impedance had been less than 2000 ohms according to the surgeon. There was no known trauma to the pt. X-rays were review by the mfr and no obvious anomalies were noted, though a section of the lead body extending from the negative electrode did appear suspicious as its appearance faded substantially on the rec'd views. A revision surgery in the future is likely. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2260288


Title: Re: Voice/Speech
Post by: dennis100 on December 28, 2017, 02:15:41 AM
Model Number 102
Event Date 09/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for patient's generator replacement. The notes mention that the patient experienced increased seizures in the recent months and is no longer experiencing coughing and voice changes with magnet activation as it normally does. The physician suspects that the generator is nearing eos based on the clinical symptoms despite device diagnostics indicating end of service - no. Additional information was received that the patient began having increased seizures three months prior to the visit in (b)(6) 2015. The patient's seizures in relation to the vns baseline is not known. There were no causal factors and the only medication changes were increase in dosage. Patient's vns device was replaced on (b)(6) 2016. The explanted generator will not be returned to manufacturer per the explant facility. No other relevant information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5396418


Title: Re: Voice/Speech
Post by: dennis100 on December 29, 2017, 01:38:08 AM
Model Number 102
Event Date 02/01/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
A report was received from the office of the patient's treating physician. It was noted that, under the care of a previous treating physician, the patient had an episode of voice alteration. The treating physician at that time checked the vns settings and assessed that the device settings were strange. They were adjusted at that time and the patient tolerated the change. Attempts for additional pertinent information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5947433


Title: Re: Voice/Speech
Post by: dennis100 on December 29, 2017, 01:39:08 AM
Model Number 102
Event Date 07/08/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported to a company representative that a recently implanted vns patient is experiencing choking, coughing, gagging, and regurgitation. The vns has never been turned on. After patient followed up with the implanting surgeon, it was determined that the patient has damaged vocal cords, and is experiencing voice alteration. The patient and neurologist refuse to turn on vns and the patient is asking to have it removed. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5940650


Title: Re: Voice/Speech
Post by: dennis100 on December 30, 2017, 02:06:30 AM
Model Number 102
Event Type Injury
Manufacturer Narrative
Corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.

Event Description
The programming history database was reviewed on (b)(6) 2016. The database contained programming history from (b)(6) 2015 only. No anomalies were noted and the device diagnostics were within normal limits.

Manufacturer Narrative

Event Description
Additional information was received regarding vns therapy setting changes that occurred due to the patient's reported complaints. It should be noted that no diagnostics were performed.

Event Description
It was reported by the physician that the patient was hospitalized and the physician's assistant was seeing the patient in the hospital. It was later noted the company representative went to see the patient in the hospital and found the patient's device programmed to 60 seconds on and 10 minutes off. The company representative stated she programmed the patient back to 30 seconds on and 5 minutes off and suggested the patient see his physician on a regular basis. The neurologist's nurse also stated the patient's voice was hoarse since the last adjustment and that he was having more seizures. The pulse width parameter was lowered from 250usec to 130usec. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5924123


Title: Re: Voice/Speech
Post by: dennis100 on January 02, 2018, 02:33:00 AM
Model Number 102
Event Date 05/01/2003
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient's mother felt the patient was less alert while on vns therapy. Further follow-up with the physician found that the patient had minimal speech output at baseline however the mother felt the patient was nonverbal with vns therapy. The changes in alertness that occurred during the implant of the patient's second vns generator were reported in mfg report #1644487-2016-02637. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6100700


Title: Re: Voice/Speech
Post by: dennis100 on January 03, 2018, 02:06:10 AM
Model Number 103
Event Type Injury
Event Description
It was later reported the patient had been seen by the neurosurgeon for an assessment as he was trying to determine the best step to take for the patient. It was noted the diagnostics continued to come back as normal and the patient feels like she needs to be turned back on as she was getting seizure control when the device was programmed on. However, it was noted when the device was turned on, the patient was having voice discomfort, but she also had a hoarse voice when the device was programmed off. Additional information was received stating the patient is returning to rhode island and her previous surgeon will be explanting the device as she does not want it anymore. It is unknown if the device is being explanted due to the reported poking feeling, due to the reported voice issues, or both. The reports of vocal cord paralysis and associated symptoms have been captured in mfr. Report 1644487-2016-02397. Attempts for additional relevant information have been unsuccessful to date.

Event Description
It was later reported by the surgeon that he had explanted the patient's vns generator and lead due to a presumed malfunction. The exact date of the explant was not provided. Attempts for additional relevant information from the surgeon have been unsuccessful to date.

Event Description
It was reported by the patient that she was having pain in her neck area. The pain was later described as a sharp-jabbing pain in her neck and feels as if the "lead is broken in half and the wires are poking" into her neck. It was noted by the physician that the patient does have a history of hypersensitivity. The programming history database was reviewed and it showed that the patient's generator was functioning as intended on (b)(6) 2016 and the impedance values was within normal limits. The patient was seen by the physician on (b)(6) 2016 and it was noted the impedance was still within normal limits and working correctly. X-ray images were reviewed by the manufacturer and it was found that the vns tie-downs, which hold the lead in place, appeared superficial in the neck. No cause for the patient's pain could conclusively be determined by the company representative that reviewed the x-rays; however, the patient's surgeon was interested in reviewing the images. The patient had been referred to a surgeon for possible replacement due to the reported pain. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6096833


Title: Re: Voice/Speech
Post by: dennis100 on January 04, 2018, 02:05:15 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type Injury
Event Description
It was initially reported the patient was scheduled to have her device explanted for an unknown reason. It was later clarified the patient was having pain around the generator site, which was the reason for the reported explant. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was further reported the patient had both her lead and generator explanted. The devices were discarded after surgery. The physician's office explained the patient experienced a change in voice, frequent throat clearing, and choking with vns stimulation. The patient began seeing a new neurologist who told the patient she did not have epilepsy, so the device was programmed off. Once the device was programmed off, the patient stated the stimulation related symptoms went away, but she still experienced pain at the generator site and requested vns removal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6282451


Title: Re: Voice/Speech
Post by: dennis100 on January 04, 2018, 02:06:03 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type Injury
Event Description
It was reported that the patient has been experiencing hypopnea and sleep apnea since early (b)(6) 2016. The apnea is quite marked from the moment patient goes to sleep, which seems to happen regularly about every two minutes when his vns stimulation is triggered. Clinic notes were received stating that the vns seems to be causing some obstructive apnea while patient is asleep, about every 2 minutes when the device stimulates. The physician suspects this is due to the output current causing tightening of the airway, possibly narrowing of the vocal cords as patient does experience some hoarseness while awake when the vns is stimulating. Therefore, the physician adjusted the settings. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6358576


Title: Re: Voice/Speech
Post by: dennis100 on January 05, 2018, 04:33:06 AM
Model Number 302-20
Device Problem Fracture
Event Date 11/16/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing hoarseness, though the device has been working well for him. Upon running a diagnostic, high lead impedance was also found. The device was disabled at this time. X-rays were performed and reviewed. Ap and lateral x-rays were available that displayed complete view of the neck and chest. Based on the images provided, the pin appeared to be fully inserted past the connector block. There were no obvious fractures or sharp angles in the images. A portion of the lead was routed behind the generator so it could not be assessed. Based on the images provided, there is no obvious cause for the high impedance; however the presence of microfractures cannot be ruled out. A follow-up with the physician clarified that the hoarseness was recent and did not bother the patient. No surgical intervention has occurred to date. No additional relevant information was received at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7095366


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2018, 04:43:35 AM
Model Number 302-30
Device Problem No Known Device Problem
Event Date 10/20/2006
Event Type Injury
Event Description
It was reported that a patient began experiencing intermittent voice alteration without stimulation. Follow up with the physician revealed he felt vns therapy was most likely the cause; however, he responded the patient's voice change may also be affected by medications or post-nasal drip. Additionally, there were no recent parameter changes that could have caused or contributed to the voice alteration and systems diagnostics were within normal limits. The physician stated the intermittent hoarseness is not associated with stimulation. Follow-up was received from the patient on 11/21/2017 indicting that her vocal cords no longer work because the implanting surgeon got too close to her left vocal cord and it no longer works;. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7128822


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2018, 04:44:30 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 03/01/2017
Event Type Injury
Event Description
It was reported that the patient had a recent endoscopy where she was diagnosed with vocal cord paralysis. The patient began to complain of hoarseness, a ball in her throat, difficulty swallowing, and shortness of breath after a vns settings increase. Diagnostics were reported within normal limits at the time. The patient was seen approximately half a year later and the vns settings were reduced. It was reported that the patient was to return to the clinic for further vns settings decrease and possible disablement to relieve the symptoms. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7076682


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2018, 04:45:22 AM
Model Number 304-20
Device Problem Low impedance
Event Date 10/24/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
Report received that low impedance was observed on a patient's vns. A manufacturer representative followed up with the patient about a month later and ran system diagnostic tests. Low impedance was still seen. The patient reportedly denied having any recent injuries or trauma that could have damaged the lead. The physician increased the patient's settings where she reportedly felt a noticeable difference. She also had voice alteration at the higher settings. This indicated some stimulation was still being delivered to the vagus nerve despite the low impedance. A review of the device history record indicated the lead had passed all quality inspections prior to being release for distribution. No surgical intervention has occurred and no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7138842


Title: Re: Voice/Speech
Post by: dennis100 on January 06, 2018, 04:46:09 AM
Device Problem Fracture
Event Type Malfunction
Event Description
It was reported by this patient's mother that the patient's lead wire had "busted" in her neck, and it was shocking, causing permanent damage to the patient's right vocal cord. The patient had surgery to remove the device, and once the patient had healed enough, they had an additional surgery to be able to speak again. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7121067


Title: Re: Voice/Speech
Post by: dennis100 on January 18, 2018, 02:32:44 AM
Model Number 303-20
Event Date 04/01/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.

Event Description
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667369


Title: Re: Voice/Speech
Post by: dennis100 on January 27, 2018, 02:10:13 AM
Model Number 302-20
Event Date 09/29/2010
Event Type Malfunction
Event Description
It was reported that high lead impedance (7/limit/high) was received after performing system diagnostics. The pt was positioned on the right side to see if the event was intermittent, but the same result was read. Additionally, turning the pt's head to the left side yielded output status =ok, impedance=unk, dcdc=0, eri=no. X-rays were taken and received by the mfr. Review of x-rays revealed the generator was able to be visualized. Its placement appeared normal in the upper left chest, the connector pins appeared to be fully inserted into the connector block, and the filter feedthroughs appeared intact. The lead body was also able to be visualized and no obvious discontinuities or sharp angles were noted, and the lead wires appeared to be intact at the connector pins. However, there was a portion of the lead placed behind the generator that could not be assessed. Additional info was received from the neurologist's office indicating the pt was recently seen and x-ray assessment from the mfr was reviewed. The neurologist programmed the pt on and diagnostics were ran which were indicative of high lead impedance. Pt's settings were lowered and it was noticed that the pt had voice alteration and could feel the stimulation with the increase in pulse width. The pt did not report any trauma that may have caused a lead fracture. The neurologist does not want to subject the pt to a lead revision at this point as he believes she is still receiving therapy and vns has been effective for her. Current interventions are to perform both system and normal mode diagnostics, and depending the outcome, reprogram the pt's settings at the next appt.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
This information was inadvertently left off of initial supplemental report #1. Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Event Description
Analysis on the lead was completed. During the visual analysis of the returned 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 6. 5mm, 9mm and 10mm from the proximal end of the anchor tether. Scanning electron microscopy was performed on the (+) white electrode quadfilar coil breaks and identified the areas as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. Pitting was observed on the coil surface. During the visual analysis of the returned 40mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 5mm, 6mm, 7. 5mm and 9. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the coil surface. 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. The slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, 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 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, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the high impedance.

Event Description
It was reported that the patient will be referred for surgery. Surgery is likely, but has not occurred to date.

Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The patient¿s generator could not be interrogated due to end of service. When a new generator was connected to the existing lead, diagnostic results showed high lead impedance. The lead was not replaced at this time. Lead replacement surgery has not occurred to date. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014 due to high impedance. Diagnostic results with the replacement lead showed lead impedance within normal limits (impedance value ¿ 860 ohms). The patient¿s device was programmed on following lead replacement. The explanted lead has been returned to the manufacturer where analysis is currently underway.

Event Description
On (b)(6) 2014, the physician reported that the patient's vns device has high impedance. The physician decided to continue therapy, because it is believed the high impedance is due to fibrosis and that the patient is still getting therapy. There was no report of traumatic events which could have caused or contributed to the event. X-rays dated (b)(6) 2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. It cannot be assessed if the lead pin is fully inserted past the connector block. Feedthru wires and lead wires at the lead pin appear intact. Lead is present behind the generator and cannot be assessed. The lead is seen routing upwards towards the electrode site. A strain relief bend and loop are both present and appear to be placed per labeling. Two tie-downs are also present and appear to placed per labeling as they are securing the intended strain relief. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. Based on this x-ray assessment, the cause for the high impedance cannot be determined. No other information has been provided.

Event Description
Analysis of the generator was completed on (b)(4) 2014. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1890175


Title: Re: Voice/Speech
Post by: dennis100 on January 30, 2018, 02:34:26 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 07/18/2017
Event Type Injury
Event Description
It was reported that the patient was having an increase in seizure frequency and duration, along with lethargy and having a hard time speaking more than 1 word. The patient's mother reported that the medications were making the patient sleepy, and the physician noted that the patient was taken off of a blood pressure medication but the seizures continued. The patient was referred for prophylactic replacement to receive the newest model devices. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6790861


Title: Re: Voice/Speech
Post by: dennis100 on January 31, 2018, 01:50:29 AM
Model Number 300-XX
Event Type Malfunction
Event Description
It was initially reported that the patient's (second) generator (m102r) was replaced due to an end of service condition as indicated by the elective replacement indicator flagged to "yes. " it was noted that at the time of surgery, that diagnostics resulted in high lead impedance following the completion of the generator replacement (m104). Review of programming history available in the manufacturer's programming history database confirmed that the high lead impedance was present at the time of the second generator's implant procedure, but no further diagnostics were available following the implant. Information received from the treating neurologist indicated that the high lead impedance did not resolve during the recent or previous implant. The high impedance was said to have been known for many years, and before the implant of the m102r. The model and serial numbers of the initial generator are unknown at this time. The patient is said to have efficacy with the therapy, in addition, to hoarseness while being stimulated, which lead to the decision of the previous and current treating neurologist to not revise the lead at this time. There have not been any reports of other adverse issues due to the high lead impedance observed. Due to the patient being implanted in the early 1990s, programming history and initial implant information was unavailable. No x-rays were available for review. There was no known patient manipulation or trauma that is believed to have caused or contributed to the high impedance observed. The recently replaced generator is unavailable for analysis as it has been disposed by the hospital.

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=1626502


Title: Re: Voice/Speech
Post by: dennis100 on February 01, 2018, 04:12:55 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type Injury
Event Description
It was initially reported the patient was scheduled to have her device explanted for an unknown reason. It was later clarified the patient was having pain around the generator site, which was the reason for the reported explant. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was further reported the patient had both her lead and generator explanted. The devices were discarded after surgery. The physician's office explained the patient experienced a change in voice, frequent throat clearing, and choking with vns stimulation. The patient began seeing a new neurologist who told the patient she did not have epilepsy, so the device was programmed off. Once the device was programmed off, the patient stated the stimulation related symptoms went away, but she still experienced pain at the generator site and requested vns removal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6282451


Title: Re: Voice/Speech
Post by: dennis100 on February 02, 2018, 02:57:46 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 11/24/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient had their generator explanted due to the patient losing (b)(6) pounds since the device was put in. It was also reported the patient was experiencing hoarseness with more than stimulation. A replacement device was not implanted. Additional relevant information has not been received to-date. The explanted device has not been received by the manufacturer to-date.

Event Description
Follow-up from the treating physician provided that they were not sure if the weight loss was related to vns, but also indicated that it was likely not related. The removal of the device was for patient comfort. The patient was experiencing hoarseness continuously. The device was turned off prior to removal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6261686


Title: Re: Voice/Speech
Post by: dennis100 on February 03, 2018, 03:20:08 AM
Model Number 103
Event Date 08/28/2013
Event Type Injury
Event Description
Additional information was received from the neurologist stating that following replacement surgery, the vns patient had severe difficulty swallowing, nerve damage, laryngeal issues, and aspiration. The patient¿s symptoms were reported to be somewhat better.

Manufacturer Narrative
Describe event or problem, corrected data: supplemental manufacturer report #01 inadvertently did not include the additional information received from the neurologist.

Event Description
On (b)(6), 2013, the patient's father reported that the patient has been experiencing several adverse events after having his most recent vns replacement on (b)(6), 2013. The adverse events included losing his voice, coughing and choking while he eats, aspiration pneumonia, and a hole in an unspecified location. Attempts for additional information have been made; however, they were unsuccessful. No additional information has been provided.

Manufacturer Narrative

Event Description
The patient was seen for follow-up with the surgeon. The device interrogation was within normal limits. The surgeon indicated that he initially thought the patient's issues were due to the patient being intubated for implant surgery. The surgeon indicated that the patient likely has recurrent left laryngeal polyps which he feels will continue to heal over the next six months. The surgeon offered the patient a follow-up appointment in three months. The surgeon reported that it is reasonable that scar tissue could have been dissected and such outcomes would be reasonable to occur.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528864


Title: Re: Voice/Speech
Post by: dennis100 on February 04, 2018, 02:16:01 AM
Model Number 302-20
Event Date 03/24/2011
Event Type Malfunction
Event Description
On (b)(6) 2011, a vns treating physician reported that the vns patient was presenting with high lead impedance from a systems diagnostic test that showed limit/high/7/no that day. The physician said that the patient doesn't know of any specific incident that could have resulted in a potential lead fracture. The physician was advised to disable the patient's device, which she did later in the appointment. She was then told that if the patient were to continue therapy, his lead would likely need to be replaced. The physician noted that recent diagnostics performed were within normal limits, but she didn't have the results in front of her. On (b)(6) 2011, the patient's spouse requested information on the coverage for explanting the patient's device due to the need for an mri. The patient's wife said, they have decided not to replace the device due to a device malfunction, which she said was a fracture. She then went on to explain that prior to the high lead impedance, the patient was experiencing pain the neck and some visual issues where he couldn't see very well. The visual issues were later determined to be the result of a stroke so the patient needed to be referred for an mri, but her understanding was that because, he had an implantable device, he could not get one. Just the pain in the neck was thought to be related to vns, not the patient's stroke. The patient had been referred for multiple cat scans, which did not show a stroke so far; now the family wants the vns removed so they can do an mri. She was told that an mri could be performed, but there are specific precautions listed in our labeling. The wife then said that the vns id card said they couldn't do mris, but when asked to verify that the statement is present, she confirmed it was not. She then changed it to it was the physician who also said that an mri could not be performed, so she was informed that an mri is possible with certain limitations, as they are performed regularly by mri facilities. She was also told that the device can remain implanted and is not required to be removed, just disabled. Since the device has not been explanted and x-rays have not been received, a lead fracture has not been confirmed as the cause for the patient's high impedance. The patient's physician reported that the patient had gone to the emergency room for the pain in the neck and that a ct and an angiogram were performed which showed nothing abnormal. The physician does not know where the pain is related to vns or not. It is not known whether, the patient will have the device removed or replaced. The physician said that they will discuss it during the patient's next appointment; the specific date of the patient's next appointment was unknown. The physician said that after the patient returned from the hospital, the patient noticed that he wasn't having any voice alteration with stimulation. The patient was worried that his device wasn't working since he could not perceive any voice alteration. The physician does not think that the pain is associated with stimulation because, the patient could not be receiving stimulation due to the high impedance since the device may not be able to deliver the full current. The patient used to always have voice alteration with stimulation but it was not serious and no interventions were ever taken. The patient denied any trauma or fall that could have caused this. The physician could not provide any more settings or diagnostics. Additional information regarding the next steps the patient and physician were going to take for the patient's high impedance and pain was requested. The physician reported that x-rays were taken on (b)(6) 2011 and that they showed no anomalies. However the x-rays were not sent to the manufacturer for review. If additional information is received, it will be reported.

Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2073724


Title: Re: Voice/Speech
Post by: dennis100 on February 09, 2018, 11:49:15 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Type Injury
Event Description
A patient reported that after implantation with vns, her left vocal cord had not been the same. It is unclear if the patient sustained a vocal cord injury during implantation with vns or after her device was explanted. The patient also reported that she had also experienced difficulty swallowing since explant. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7194052


Title: Re: Voice/Speech
Post by: dennis100 on February 09, 2018, 11:50:01 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 05/21/2010
Event Type Injury
Event Description
It was reported via social media comment by the patient that following the patient's two previous vns surgeries that the patient had so much scar tissue that her vocal cords were damaged and she could only whisper for two years before her voice returned. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7168487


Title: Re: Voice/Speech
Post by: dennis100 on February 10, 2018, 02:12:05 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 09/29/2017
Event Type Injury
Event Description
It was reported that a patient had vocal cord complications. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7173606


Title: Re: Voice/Speech
Post by: dennis100 on February 15, 2018, 02:34:35 AM
Model Number 302-20
Event Date 08/24/2011
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 a vns patient was experiencing painful "stinging" stimulation in the neck that would cause headaches. The patient was referred for a surgical consult for the painful stimulation, but surgery is not planned at this time. The vns diagnostics history is reported to be currently a dcdc code = 0, indicating low impedance. As the low impedance is occurring in conjunction with the painful stimulation, a short circuit condition of the lead may be occurring. Review of previous vns diagnostics history shows a dcdc code = 3 in 2007. As this has currently dropped to a dcdc code = 0, a short circuit condition is suspected. Attempts for additional information are in progress.

Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2012. An implant card was also received to the manufacturer indicating diagnostics with the new vns generator and resident lead were within normal limits. The generator was returned on (b)(6) 2012 and product analysis is pending.

Event Description
Reporter indicated the patient was seen in clinic on (b)(6) 2012. Systems and normal mode diagnostics were within normal limits. The patient's painful stimulation in the neck resolved with a decrease in the output current from 1. 25ma to 1. 0ma. In addition, the patient has voice alteration with stimulation, indicating the intended therapy is likely being delivered. No surgery to replace the vns generator or lead is planned at this time; the family may wish to replace the generator later this year.

Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.

Event Description
Reporter indicated to the manufacturer that it is unknown on which vns diagnostics test the high lead impedance was obtained (systems or normal mode diagnostics). The patient had no known trauma and does not manipulate the vns. X-rays were not performed.

Event Description
All further attempts to the reporter for additional information have been unsuccessful to date. Per the patient's caregiver, the patient is to have additional vns diagnostics testing performed before seeing the surgeon again, but this has not occurred to date. In addition, the patient had seen a new neurologist in (b)(6) 2011. Lamictal medication was increased and the vns settings were changed, which resolved the painful vns stimulation and pain. It is still unknown if the dcdc = 0 result originally reported was received on a systems or normal mode diagnostics test. No surgery date has been scheduled to date.

Event Description
Analysis of the vns generator was completed. No anomalies were noted, and the generator performed per specifications. The generator was not at end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2342431


Title: Re: Voice/Speech
Post by: dennis100 on February 18, 2018, 02:41:19 AM
Model Number 102
Event Date 11/01/2008
Event Type Injury
Event Description
Initial reporter indicated that they had been implanted with the vns for about three years and was losing weight again like last time. Pt reported that when they lose weight they get depressed and "will think about committing suicide. " the last time the pt lost weight "someone went over to the dr's office and did something to the device. It was not known what they did, but afterwards, he started gaining weight again and all the other things went away. " no changes in medication, lifestyle, or diet reported. Pt has vns programming titrations. Reported the pt had not had a programming change for at least six months. The pt was also feeling a shocking in his neck and hoarseness when the device stimulates. Good faith attempts are being made at the pt's treating physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1266293


Title: Re: Voice/Speech
Post by: dennis100 on February 25, 2018, 01:37:21 AM
Event Date 04/01/2010
Event Type Malfunction
Event Description
It was reported in manufacturer report # 1644487-2012-00029 that a vns patient had a history of seizures and began to have an increase in seizures following implant of the vns lead and generator. The pt reportedly went to the physician and met another pt with similar issues. This report is to address the pt with similar issues as noted in manufacturer report # 1644487-2012-00029. The original pt's report indicated he or she experienced hoarseness and passing out after seizures; however, it is unk if the "similar issues" includes these events as well as the increased seizures. It is unk if any interventions have been taken. This information was reported to the fda in april 2010; however, it was not believed that this event had been passed on to the manufacturer. Attempts for further information are not possible as the pt and physician information were not available.

Manufacturer Narrative
Initial reported listed the event as a "serious injury" however it is a "malfunction". The information has been corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403802


Title: Re: Voice/Speech
Post by: dennis100 on February 26, 2018, 02:03:29 AM
Model Number 302-20
Event Date 06/21/2007
Event Type Injury
Event Description
It was reported through a clinical study that a vns patient experienced transverse cutaneous nerve of neck neuropathy post-vns implantation, decreased sensitivity over cervical scar post-vns implantation, and voice hoarseness with stimulation. The severity of the transverse cutaneous nerve of neck neuropathy post-vns implantation and decreased sensitivity over cervical scar post-vns implantation events in accordance to the study coordinator/nurse were mild and had a definite relationship to vns implantation. The events of transverse cutaneous nerve of neck neuropathy post-vns implantation and decreased sensitivity over cervical scar post-vns implantation were noted on (b)(6) 2007 and were noted to be ongoing at the end of study. Moreover, the events were described as not serious adverse events and no intervention was taken for the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2463092


Title: Re: Voice/Speech
Post by: dennis100 on March 08, 2018, 02:31:07 AM
Model Number 102
Event Date 05/16/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. It was indicated that the initial reporter had not seen the patient back as she was only there for a follow up for a brain tumor that she had prior to being implanted. Per the reporter, she was the one who was attempting to interrogate the patient and she got "nothing" from the device and they were unable to perform the mri. She indicated that they are having no problems at all with their programming system and that it is functioning as intended. They have not seen the patient again as she only follows up every year or so only for this mri. Follow up was then performed with the patient's treating neurologist, who indicated that the device was last interrogated in (b)(6) 2010. She did indicate that the patient was seen again in (b)(6) 2012. Interrogation was not attempted at that time, however she felt that the vns was working as the patient was still experiencing cyclical voice alterations with stimulation. The neurologist indicated that she feels the generator has reached end of service and that is the reason that it could not be communicated with. No additional information was provided.

Event Description
It was reported by an mri technician that while trying to disable the device, they were receiving a failure to communicate message and were unable to interrogate the generator. Multiple programming systems were used and troubleshooting steps, including checking the wand battery and making sure that the programming system was unplugged from the wall were performed, however, the device could not be interrogated. The patient indicated at the time that she was unsure of the last time her device was checked stating that it may have been in 2009. A rough estimation of battery life was calculated based on available programming history which indicated that the device may be at or nearing end of service. However, end of service has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2614735


Title: Re: Voice/Speech
Post by: dennis100 on March 08, 2018, 02:32:25 AM
Model Number 302-20
Event Date 04/18/2012
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred but did not cause or contribute to death or serious injury.

Event Description
An analysis was performed on the returned lead portions. During the visual analysis the green (-) electrode quadfilar coil appeared to be discolored and broken in several areas. Visual analysis was performed and identified the areas as being thin, with pitting which prevented identification of the coil fracture type and evidence of electro-etching. One of the coil break areas was identified as being mechanically damaged which prevented identification of the coil fracture type with evidence of electro-etching. During the cleaning process the green (-) electrode ribbon, spot-weld / slug and coil became detached. This most likely occurred due to the vibration of the sonicator used in the cleaning process. Visual analysis was performed on the spot-weld / slug and identified evidence of where the quadfilar coil had been mounted on the slug. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Additionally it was observed there was outer and inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the slice marks observed on the outer silicone tubing. With the exception of the observed discontinuities, 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 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, and no other discontinuities were identified.

Manufacturer Narrative
Date of event: corrected data to (b)(6) 2012.

Event Description
It was reported that a vns patient was seen in clinic and they had high lead impedance. In addition, the patient has has reported hoarseness since reimplant last year. The patient has been referred to a surgeon for lead revision surgery. Because of scheduling the patient will not have the surgery until (b)(6) 2012. Their output current was initially decreased but his seizures increased significantly so they have turned him back up to his previous settings and this has got his seizures back under control. Good faith attempts are underway for further information.

Event Description
The patient had full revision surgery and their explanted products are at the manufacturer for pending analysis completion. Their surgeon decided to prophylactically replace their generator. No further information has been attained about their reported events.

Manufacturer Narrative
Device failure occcurred but did not cause or contribute to a death or serious injury.

Event Description
Further diagnostic history was reviewed. Unknown date of actual event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2622788


Title: Re: Voice/Speech
Post by: dennis100 on March 08, 2018, 09:45:49 AM
Event Date 06/03/2011
Event Type Injury
Event Description
It was reported that the vns patient has been experiencing "vocal cord issues" since implant. The patient was seen by an ent physician who indicated that he believes the lead was implanted too close to the vocal cords. It was also noted that the patient has not seen much efficacy since implant. The patient was reportedly going to see the implanting surgeon for further evaluation however the surgeon's office indicated that the patient has not been seen or made an appointment. Attempts for further information from the neurologist's office have been unsuccessful to date. Attempts for the product information were unsuccessful.

Event Description
Additional information was received indicating the patient's vocal cord issue has resolved.

Event Description
On (b)(6) 2012, additional information was received indicated that the patient had hoarseness and awakening at night with vns stimulation noted in (b)(6) 2011. It was confirmed that vocal cord issues were related to electrodes being placed too close to the larynx. No hoarseness was noted (b)(6) 2011. On (b)(6) 2011, the hoarseness was intermittent but then constant on in (b)(6) 2011. A note indicated the hoarseness appeared to have resolved following the thyroidectomy. The thyroid issues were not believed to be related to vns.

Manufacturer Narrative

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

Manufacturer Narrative
Event date, corrected data: previously submitted mdr indicated an incorrect event date. The patient's physician believes that the vocal cord issues are related to the electrodes being placed too close to the larynx at the time of implant; therefore, the event date is the date of implant: (b)(6) 2011. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603575


Title: Re: Voice/Speech
Post by: dennis100 on March 09, 2018, 03:32:03 AM
Model Number 302-20
Device Problem Fracture
Event Date 02/01/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the physician observed high impedance with no output current delivered on the patient's device. The physician noted that the patient was experiencing no discomfort, increase in seizures ant that the patient was still experiencing voice alteration with stimulation. 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=7297630


Title: Re: Voice/Speech
Post by: dennis100 on March 09, 2018, 03:32:50 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 07/06/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through a study adverse event form that a patient's vns was disabled due to laryngospasms. The severity of the laryngospasms was marked as severe and life-threatening. No clarification as to why the event was considered life-threatening has been received to date. As a result of this event, the patient discontinued the study. After the vns was disabled, the problem resolved. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7290396


Title: Re: Voice/Speech
Post by: dennis100 on March 10, 2018, 02:12:59 AM
Model Number 300-20
Device Problem Fracture
Event Date 01/01/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
Per nurse practitioner, the patient reported feeling intense stimulation recently to the point of waking him up at night and bouts of severe cough and unable to speak intermittently. System diagnostic with high impedance 6113 ohms was detected. Prior to these recent changes the patient reported not detecting stimulation and no voice strain with 0. 75 milliamps and 1. 0 milliamps magnet activation. The patient also reports no blunt trauma to the area around the generator and/or neck area. Patient does bowl on a regular basis and reports these intense stimulations during sleep, laying down, during bowling, standing and other times in the day as well. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7268872


Title: Re: Voice/Speech
Post by: dennis100 on March 10, 2018, 02:13:44 AM
Model Number 304-30
Device Problem No Known Device Problem
Event Date 06/05/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient experienced constant hoarseness since her vns implant surgery. The patient was referred for vocal medialization surgery, and it was believed that the patient's vocal cord was possibly nicked during the implant. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7282410


Title: Re: Voice/Speech
Post by: dennis100 on March 11, 2018, 01:17:05 AM
Model Number 302-30
Event Date 06/18/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
Clinic notes dated (b)(6) 2011 and (b)(6) 2012, were reviewed on (b)(6) 2012 and indicated that the device was "working well. " on (b)(6) 2012, it was reported that the patient's explanted devices had been discarded and were unavailable for product return. Additional information was received on (b)(6) 2012, indicating that high impedance was not seen until the generator was replaced. Pre-operative diagnostics were not performed. A battery life calculation on (b)(6) 2012, indicated negative results at the time of revision surgery.

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
An implant card from this vns patient's implant surgery on (b)(6) 2012 was received on (b)(6)2012 indicating lead impedance was seen after the new generator was implanted; therefore, the lead was also replaced. Operative notes were received on (b)(6) 2012. The generator was explanted and a new model 103 generator was attached to the existing leads. Interrogation showed lead impedance to be high. Repeat interrogation showed the same thing. The generator was disconnected and then reconnected and still showed high impedance. During dissection for lead replacement, a large amount of fibrous adhesions were noted where the lead was attached to the nerve. The uppermost portion of the old lead was dissected away from the nerve allowing for a longer exposed nerve for attachment. Interrogation was performed and lead impedance was okay. A strain loop was created with two pledgets and then another strain loop was created. The old lead was bluntly removed. The generator was disconnected, the lead was tunneled to the generator site, the generator was connected to the lead, and interrogation showed normal lead impedance and full battery life. The generator was placed in the pocket, and another interrogation showed normal lead impedance. Notes from the patient's appointment on (b)(6) 2012 were also received in (b)(6) 2012. The notes indicated that the patient experienced a hoarse voice for a little while; however, it appeared to be better on this date. The patient's incisions were reported to be healing well without evidence of infection. No hoarseness was detected. It was noted that injury or irritation of the vagus nerve or recurrent laryngeal nerve was a concern; however, it was believed that if the nerve was actually damaged, the effect on voice would be more dramatic. It was suspected that some vocal cord irritation form endotracheal intubation was the culprit, hence the improvement with time. If the issue was of concern in a few weeks, the patient would be referred to an ent for visualization of the cords. Attempts for product return and additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2669499


Title: Re: Voice/Speech
Post by: dennis100 on March 12, 2018, 01:41:32 AM
Model Number 302-30
Device Problems High impedance; Improper or incorrect procedure or method
Event Date 06/13/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, a vns treating physician reported that the vns patient was at settings of output=2. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=3min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics showed output=ok/lead impedance=ok/dcdc=3/eri=no. The patient was at these settings until (b)(6) 2011, when he was changed to a more rapid cycling of output=2. 5ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics were still output=ok/lead impedance=ok/dcdc=3/eri=no. The physician commented that this patient has only been seen by him since (b)(6) 2010. The physician further stated that despite instructing the patient to return sooner, the patient was not seen again until (b)(6) 2012. The patient was reported to be doing much better, with seizures reduced from 2 per week to 2-3 per month. The patient is mentally handicapped so the physician believes that reporting is not great, but the patient does report continuing to feel the device in his throat during stimulation and there is a subtle change in his voice. The patient's parameters continue to be the same, however, his normal mode diagnostics show, output status=limit/output=2. 5ma/lead impedance=high/dcdc=7/eri=no. The physician reported that he feels the high impedance is due to a battery failure and not lead failure as there has not been any reported trauma or issue that would be expected to have damaged the lead. The patient still feels stimulation. Clinic notes were also received. Clinic notes dated (b)6) 2012, revealed that the patient has clearly improved with about 2-3 seizures per month, down from 6 per month last visit. The intensity and duration are about the same. The patient's mother called in the fall stating that the patient has some swelling at the vns site, but it resolved spontaneously. The patient's mother reported a significant decrease in the frequency of his seizures that is likely related to the rapid cycling of his vns, as no other medication changes were made. The physician stated that vns interrogation indicated, high lead impedance, which the physician attributes to battery failure, as the patient continues to report feeling stimulation intermittently. The physician commented that he had to re-program the patient to 30seconds on time, in order to run the diagnostics, and then he switched the patient back. The physician later reported on (b)(6) 2012, that he saw the patient again and system diagnostics were performed which also showed high impedance; output=limit/lead impedance=high/dcdc=7. The physician disabled the device due to high impedance and the patient was referred to a surgeon for replacement. The physician stated that he did not order any x-rays. The physician stated that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. He also stated that the patient normally has voice alteration and is nothing atypical for the patient. The swelling was reported in (b)(6) and resolved spontaneously. He believed the swelling was at the generator location, but was unsure. It was also unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the swelling. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient underwent a full revision surgery that day. The leads were replaced due to high impedance and the generator was replaced for prophylactic reasons. The hospital reported that the products were discarded in surgery as the surgeon routinely asks the staff to discard the explanted devices.

Event Description
The physician reported that the revision surgery done on (b)(6) 2012 was very lengthy and difficult and that he had a long time recovering from it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2645547


Title: Re: Voice/Speech
Post by: dennis100 on March 12, 2018, 01:42:34 AM
Model Number 103
Event Date 05/17/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, clinic notes from a vns treating physician were received. Review of the clinic notes dated (b)(6) 2012, revealed that the patient's seizures seem to be more severe. The patient was reported to have been in a "slump" since last visit and not doing as well. The patient's nightly events are slightly worse and the patient is not improving as much. The physician increased the patient's settings but still no better. The patient was reported to not have any daytime seizures but has nightly nocturnal seizures, not as severe at times. Clinic notes dated (b)(6) 2012, were also received which indicate that the patient's seizures are less severe and no change in frequency. The patient's seizures were reported to have improved with vns changes. The patient stated that nocturnal events occur nightly but not as severe. The patient's vns was adjusted to output=2. 25ma/frequency=20hz/pulse width=250usec/on time=60sec/off time=0. 8min/magnet output=2. 5ma/magnet on time=60sec/magnet pulse width=500usec. Attempts for additional information have been made but no further information has been received from the physician. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2012, when the physician reported that the change in seizure pattern, increase in seizures, and voice alteration were "not an issue". As an intervention the physician adjusted the vns settings and vimpat dosing. The increase in seizures was below pre-vns levels. The voice alteration was associated with stimulation but was not a continual issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2646007


Title: Re: Voice/Speech
Post by: dennis100 on March 12, 2018, 01:44:03 AM
Model Number 302-20
Event Date 02/29/2012
Event Type Malfunction
Event Description
On (b)(6) 2012 a vns treating nurse reported that the vns patient has high impedance with a dcdc of 7. The care giver noticed that the patient's hoarseness was gone. It was reported that x-rays were taken with a potential lead breakage and that they would be sent to the manufacturer for review. The battery was stated to be ok and the patient's settings are output=1. 75ma/pulse width=500usec/frequency=30hz/on time=30sec/off time=3min/magnet output=3ma/magnet on time=30sec. X-rays were received and reviewed by the manufacturer. The lead connector pin appeared to be fully inserted into the generator connector block. Part of lead is placed behind the generator and could not be assessed. No obvious lead discontinuity found on part of the lead that could be assessed. Due to the quality of the images, part of the lead close to the electrodes cannot be fully assessed. Based on the x-ray images, the cause of the reported high impedance cannot be identified.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Event Description
On (b)(6) 2012, the programming history was reviewed. A battery life calculation was performed which showed 1. 03 years remaining until neos=yes.

Event Description
On (b)(6) 2013, the manufacturing records for the lead were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(6) 2012, when the nurse reported that the patient doesn't speak, but communicates by pointing at pictures; sometimes when the vns stimulates the patient will make a sound that sounds like "hoarseness". This has not occurred since (b)(6) 2011. The nurse stated that she does not know the relationship of the hoarseness to vns. System diagnostics were performed on (b)(6) 2011, which showed dcdc of 2 and then on (b)(6) 2012, system diagnostics showed high impedance with dcdc=7. Therefore x-rays were ordered. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The generator has been disabled due to the high impedance. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2666564


Title: Re: Voice/Speech
Post by: dennis100 on March 19, 2018, 01:52:19 AM
Model Number 102
Event Date 06/18/2012
Event Type Injury
Event Description
A registered nurse at the treating physician's office reported on (b)(6) 2012 to the company representative that the patient complained of left mid axillary pain and thought it was due to the vns having moved. A chest x-ray was ordered, and the nurse reported that it appears to have shifted slightly inferomedially. The electrode reportedly has moved as well. Previously, it was reported on (b)(6) 2012 from the surgeon's office that they were planning on seeing the patient for evaluation of the patient's reported complaint of pain at the generator site. The neurologist's office referred the patient to the ent to see if the complaint she had was related to another reason other than vns. An ent evaluated the patient and concluded that there may be generator migration which may be causing the discomfort at the generator site. Clinic notes dated (b)(6) 2012 reported that the patient still remains with difficulty tolerating the device. She has intermittent dysphonia, pain in the neck radiating to the ear and the mandible and sometimes problems swallowing. The previous visit they discussed referral to ent for evaluation, and the patient requested for the referral. The referral requested for evaluation of the neck, ear and mandible pain related to vns to see if there is a need to revise the area where the device is placed. On the previous visit on (b)(6) 2012, the patient presented with no side effects. Follow up with the referring neurologist revealed that the pain was first observed on (b)(6) 2010. The dysphonia and trouble swallowing are reportedly recurring problems noticed in (b)(6) 2010. The patient was advised to have x-rays taken and to be evaluated by a neurosurgeon. No patient manipulation or trauma occurred that is believed to have caused/contributed to the events, and no causal or contributory changes preceded the onset of the events either. The neurologist reported that the pain, trouble swallowing, and dysphonia are associated with stimulation. The patient does not have a pre-existing medical history of having difficulty swallowing prior to vns. Although surgery was still being considered in (b)(6) 2012, it had not been scheduled to date due to the physician wanting the patient undergo imaging studies. Attempts for additional information from the surgeon and treating physician's office have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received from the treating neurologist which revealed that medical/surgical intervention was planned with regards to the migration and discomfort at the generator site due to patient comfort and not to preclude a serious injury. The outcome of the repositioning surgery was "good", per the physician. The lead migrated due to "body habitus" (patient physique), however details were not provided. No causal or contributory programming or medication changes precede the onset of the lead migration. X-rays of the patient's vns were taken but have not been received by the manufacturer to date. The x-ray report was provided by the physician which indicated that the patient "complained of pain in the region of the vns device. Also states that she feels the device has shifted. Exam was done for vns placement. " chest x-ray of (b)(6) 2012 and also compared to soft tissues of the neck x-ray of (b)(6) 2010. The vns generator reportedly appeared to have shifted slightly inferomedically relative to its position previously. The electrode coursing into the base of the left neck appears intact; however, it also appeared to have shifted slightly, per the report. Previously, it was overlying the 2nd rib and on (b)(6) 2012 appeared to have shifted interomedially and was overlying the left apex. It coursed into the base of the neck as previously.

Manufacturer Narrative

Event Description
The patient had vns repositioning surgery on (b)(6) 2012. Further details were not available. Attempts for additional information have been unsuccessful to date. The clinic notes dated (b)(6) 2012, reported that the generator appeared to have shifted slightly inferomedially which was believed to have caused pain to the neck and left face area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2792685


Title: Re: Voice/Speech
Post by: dennis100 on March 20, 2018, 01:25:42 AM
Model Number 302-20
Event Date 09/11/2012
Event Type Malfunction
Event Description
The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

Event Description
It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784912


Title: Re: Voice/Speech
Post by: dennis100 on March 21, 2018, 03:16:07 AM
Model Number 102
Event Date 09/02/2012
Event Type Injury
Event Description
A nurse in the emergency room reported on (b)(6) 2012, that the vns patient had presented with constant pain in the chest that had started that day. The nurse indicated that the only intervention that they would take it using the vns magnet to disable the device temporarily because they did not think that anything is wrong with the device. She said that another nurse had submitted the report indicating that the patient believed the device was malfunctioning, but that is because she misunderstood what the nurse had said. The patient later reported on (b)(6) 2012, that she wanted to have her vns device removed to due to erratic stimulation which is now painful and constantly stimulating. She mentioned that her device was disabled in 2010 and she did not understand why it is now going off. The patient said that she did not like the way the therapy felt at the time which is why the device was disabled. Additional information was received on (b)(6) 2012, indicating that the patent was scheduled for explant. The patient had vns explant on (b)(6) 2012. Attempts for product return are unsuccessful as the explanting facility requires a patient signed release, and they reported that they will not return to the manufacturer. Follow up with the neurologist's office indicated that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of activity. There were no noted causal or contributory factors, and no programming/diagnostics were provided. The patient was being treated by a new ent surgeon. (b)(6) also indicated that the patient called their office on (b)(6) 2012, due to the pain and erratic stimulation in the chest for which she wanted the device removed. Follow up with the patient's treating ent surgeon have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received from the patient's explanting surgeon which revealed that the device explanted due to patient comfort. Only the generator was explanted. The pain was believed to be related to "misfiring - headaches, hoarseness, trouble breathing. " the relationship of these events to vns are unclear with the information provided. No causal or contributory programming or medication changes precede the onset of the continuous/erratic stimulation and pain. In addition, no patient manipulation or trauma occur that is believed to have caused/contributed to continuous/erratic stimulation and pain. As of (b)(6) 2012, it was unknown if the patient's symptoms have resolved since explant because the patient had not returned to the surgeon's office. Attempts for return of the explanted device are unsuccessful, as the explanting facility does not return products per hospital policy. A letter was received from the patient on (b)(6)2012. She indicated that on (b)(6) 2012, she had a "breathing problem and it was as if "she was suffocating". She reported that she did not relate these events vns. Then on (b)(6) 2012, she went to the emergency room and "wore a magnet for over a week. " she reported that her device was tuned off two years ago, and "the surgeon said it was malfunctioning" the neurologist at the emergency room "said this was not normal and also said it was malfunctioning". The patient continued to state that she was told (by an unknown source) that she "could have problems in the future from this problem". She was writing with regards for reimbursement for "pain and suffering". Attempts for additional information from the treating physicians have been unsuccessful to date. Previous follow up with the neurologist regarding the device disablement in 2010 was performed which revealed that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of energy during physical activity. These events were reportedly related to stimulation, except it is unknown if the decreased energy level was. The patient claimed her energy level decreased during physical activity, but this could not be confirmed by the physician's office. There were no noted causal or contributory factors, and no programming/diagnostics were provided. No additional interventions were taken in 2010, and no additional information was provided.

Event Description
Additional information was received from the explant surgeon. The generator was explanted at request of patient. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769409


Title: Re: Voice/Speech
Post by: dennis100 on March 21, 2018, 03:18:26 AM
Model Number 102
Event Date 08/26/2011
Event Type Injury
Event Description
(b)(4). Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the patient's settings were changed. The patient's neurologist felt that the patient had pseudoseizures and anxiety. The patient was requesting explant. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, this patient's settings were adjusted to reach more efficacious levels. Diagnostics on this day were within normal limits. On (b)(6) 2012, the patient was reportedly having an increase in seizures, lack of efficacy, voice alteration, and an increase in depression. The patient reported potentially having the explanted due to the adverse events.

Event Description
Clinic notes regarding this vns patient were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that the patient presented with a major complaint of frequent migraines. These were occurring so often that the patient became dehydrated and was hospitalized numerous times in the past year. The patient had to have iv fluids and narcotics in order to control them. The patient and her husband both felt that the patient was having more migraines since vns implant. The patient came in to request that the device was turned down or off to see if this may have some effect on her migraine frequency. The patient's headaches were now almost daily and severe two or three times a week. The patient was largely in the right side of her head and was associated with an inability to stand noise, light, movement, nausea, and vomiting. The patient was seeing a physician for the migraine treatment at least one per month (or every other month). It was also noted that the vns had not seemed to help the patient's seizures. The exact seizure frequency was not known but that patient averaged, at least, anywhere from two to five generalized tonic-clonic seizures per month and six complex partial seizures per month. The patient believed these were less now than before although the previous frequency estimate was somewhere between four and five per month. The patient's settings were altered at this appointment. The physician noted that the changes would be turning the device to less than therapeutic levels. The physician also seriously doubted that it would cause any migraines. It was noted that the patient's medications were all associated with increase seizures in patients predisposed; however, the patient had more of a problem with the pain from migraines. The patient's settings from (b)(6) 2011 were provided. It was also noted that patient wanted her vns turned down or off. The patient's migraines seemed worse with vns. Notes dated (b)(6) 2011 indicated that the patient's severe migraines were worse and more frequent and that the patient had been hospitalized with migraines with dehydration. The patient's seizure and headache frequencies were also noted. Notes dated (b)(6) 2010 also provided seizure and headache frequencies and stated that the migraines may last up to four days. The patient felt that the partial seizure frequency had decreased. Notes dated (b)(6) 2010 indicated the patient's seizure frequency, but the text was illegible. It was written that the patient felt that the partial seizure frequency decreased. The patient's migraines may last up to four days.

Event Description
Per the return product form, the device was explanted because the patient did not want it. Product analysis of the explanted generator found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿pain with stimulation¿). 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 generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. Based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Since a portion of the lead assembly (body) including the electrodes array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.

Event Description
Clinic notes dated (b)(6) 2013 were received indicating that the patient was referred for removal of her vns. The patient had three grand mal seizures per month on average. The device was disabled in (b)(6) 2012. The patient was currently having one grand mal seizure and one partial complex seizure per week. The patient had significant a significant medical condition of depression. The patient also presented with headaches. The headaches occurred daily. Associated signs and symptoms included phonophobia, photophobia, and scalp soreness. The headaches were incapacitating. Stress, phonophobia, and photophobia were possible exacerbating factors. The patient is continues to have migraines which she takes morphine for. The physician would like to find a different non-opioid medication to control the patient¿s headaches. Per the physician morphine had the tendency to lower seizure threshold in some patient and can cause rebound headaches.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2773585


Title: Re: Voice/Speech
Post by: dennis100 on March 22, 2018, 12:41:02 AM
Model Number 304-20
Event Date 08/01/2012
Event Type Injury
Event Description
It was reported that the patient was experiencing extreme fatigue after having his vns generator replaced on (b)(6) 2012. Per the patient's wife, since vns stimulation was resumed, the patient has been more tired and sleeping longer. Information was later received indicating the patient has had shortness of breath since the replacement and a physician indicated that the patient's o2 levels are lower than normal and have yet to increase to the proper levels. Reportedly there was difficulty intubating the patient during the replacement surgery which may have caused problems with the vocal cords. The patient;s voice was noted as "hoarse and raspy" and there are concerns for the patient's air capacity. It was also noted that around (b)(6) 2012, "some sort of internal stitching began to pop nearly out of the skin. " attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766128


Title: Re: Voice/Speech
Post by: dennis100 on March 23, 2018, 01:33:25 AM
Model Number 102
Event Date 09/01/2012
Event Type Injury
Event Description
Information was received that a vns patient had their generator replaced. Per the patient's mother about a month ago the patient experienced painful stimulation in the left neck which the mother described as the vns device "misfiring. " the patient presented to (b)(6) hospital where er physicians were unable to stop stimulation when the magnet was placed over the device. The mother states the device was located in a difficult to access place and was approximately six years old. Per mom, the er physicians did not understand why they could not stop stimulation with magnet placement, and had to get a programmer to turn off the device. Per mom, after the vns was turned off, the family flew to (b)(6) where established physicians reimplanted the vns on (b)(6) 2012. Their mother reported that their voice was hoarse for 2 ½ weeks after the painful stimulation episode , but is resolved now. The surgeon's office reported that the patient reported painful stimulation in the throat area that resolved with the vns being programmed off and felt surgery needed to investigate the pain event. Their device was not at eos and diagnostics were reported in the or to be within normal limits. Product analysis was completed on the returned generator. 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 pulse generator. No eri flags were identified during the analysis. Although the reported allegation of "painful stimulation" cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. The septum was cored. However, no evidence of bodily fluid remnants were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation"). Magnet activations performed at the bench (at a distance of one-inch, spacer block, from generator); demonstrate the appropriate magnet output for the programmed settings. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator output was disabled using a magnet at a distance of one inch using a spacer block with no observed anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2846784


Title: Re: Voice/Speech
Post by: dennis100 on March 23, 2018, 01:34:34 AM
Model Number 103
Event Date 09/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the device had been discarded. Attempts for additional information have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The patient presented for low battery. The patient had excellent prior response to stimulation with reduction of seizures and earlier abortion of her seizure episodes with use of the magnet. May weeks ago, the patient began having sporadic discharges from her vns which results in throat discomfort, coughing, breathing difficulties, and speech hoarseness. The patient was also concerned that the increase in seizures could make it difficult to work. The notes stated that the patient needed urgent replacement of her device due to the severe symptoms attributable to low battery resulting in sporadic discharges. An implant card dated (b)(6) 2012 indicated that the patient underwent generator revision on (b)(6) 2012 due to battery depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2847361


Title: Re: Voice/Speech
Post by: dennis100 on March 25, 2018, 02:05:32 AM
Model Number 103
Event Date 08/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was making new "breathy or wheezy" noises that were different than normal. The patient was noted as having to go to the hospital in august due to increased seizures. The patient was noted as no longer experiencing seizures in the daytime. The patient used to experience 1-2 seizures per week in the daytime that are approximately 30 seconds in duration however now the patient experiences 5 seizures per night that are approximately 10 seconds in duration. Vns magnet activations are usually effective at stopping the patient's seizures. The patient was also noted as experiencing a change in vocalizations. The patient's vns was noted as now being near end of service. The patient has been referred for vns generator replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2832892


Title: Re: Voice/Speech
Post by: dennis100 on March 26, 2018, 12:51:32 AM
Model Number 302-20
Event Date 05/01/2012
Event Type Malfunction
Event Description
On (b)(6) 2013 the physician¿s nurse stated that per the operative note from surgery, the old generator was removed from the pocket, and a replacement device was connected to a lead and the lead was found to be functioning normally. The battery was put back into the pocket and tested again with normal impedance and proper lead function found. She said that it does not appear from the notes that any other actions were taken except replacing the generator which reportedly resolved the high impedance. However, per the implant card, the patient's lead was indeed replaced. They have not heard from the patient since the surgery so assume everything is okay. It was not dictated in the notes if the electrode was off of the nerve. No additional information or clarification could be provided.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution. Describe event or problem: corrected data: follow-up report #1 inadvertently did not include the information that the lead and generator were replaced and that the generator was returned to the manufacturer for evaluation. If explanted, give date (mo/day/yr): corrected data: follow-up report #1 inadvertently did not include the explant date of the lead.

Event Description
Additional information was received that the patient had a generator and lead replacement. Only the generator was returned to the manufacturer for evaluation. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Event Description
It was reported that the patient's vns was now indicating high lead impedance. Follow-up with the site found the high impedance is believed to be related to the electrode no longer being on the nerve based on ct scans taken in may of 2012. No trauma or manipulation is believed to have caused or contributed to the high lead impedance. The patient was noted as having an "exponential" decrease in seizures with vns however they suspected an issue when the seizures began to return. The increased seizures are back at the pre-vns baseline. The patient was noted as now "playing" with the lead in his neck which is in a ball that can be felt by the patient. The magnet has been used to temporarily disable the patient's vns however the site has not had a chance to turn