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Author Topic: Voice/Speech  (Read 181727 times)
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dennis100
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« 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
« Last Edit: December 31, 2015, 01:12:28 AM by dennis100 » Logged
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« Reply #1 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
« Last Edit: October 01, 2015, 06:54:44 AM by dennis100 » Logged
dennis100
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« Reply #2 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
« Last Edit: October 01, 2015, 06:55:05 AM by dennis100 » Logged
dennis100
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« Reply #3 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
« Last Edit: October 01, 2015, 06:55:25 AM by dennis100 » Logged
dennis100
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« Reply #4 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
« Last Edit: October 01, 2015, 06:55:42 AM by dennis100 » Logged
dennis100
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« Reply #5 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
« Last Edit: October 01, 2015, 06:55:58 AM by dennis100 » Logged
dennis100
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« Reply #6 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
« Last Edit: October 01, 2015, 06:56:13 AM by dennis100 » Logged
dennis100
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« Reply #7 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
« Last Edit: October 01, 2015, 06:56:30 AM by dennis100 » Logged
dennis100
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« Reply #8 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
« Last Edit: October 01, 2015, 06:56:42 AM by dennis100 » Logged
dennis100
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« Reply #9 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
« Last Edit: October 01, 2015, 06:56:59 AM by dennis100 » Logged
dennis100
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« Reply #10 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
« Last Edit: October 01, 2015, 06:57:15 AM by dennis100 » Logged
dennis100
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« Reply #11 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
« Last Edit: October 01, 2015, 06:57:30 AM by dennis100 » Logged
dennis100
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« Reply #12 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
« Last Edit: October 01, 2015, 06:57:43 AM by dennis100 » Logged
dennis100
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« Reply #13 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
« Last Edit: October 01, 2015, 06:58:04 AM by dennis100 » Logged
dennis100
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« Reply #14 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
« Last Edit: October 01, 2015, 06:58:21 AM by dennis100 » Logged
dennis100
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« Reply #15 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
« Last Edit: October 01, 2015, 06:58:39 AM by dennis100 » Logged
dennis100
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« Reply #16 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
« Last Edit: October 01, 2015, 06:58:54 AM by dennis100 » Logged
dennis100
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« Reply #17 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
« Last Edit: October 01, 2015, 06:59:13 AM by dennis100 » Logged
dennis100
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« Reply #18 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
« Last Edit: October 01, 2015, 06:59:29 AM by dennis100 » Logged
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« Reply #19 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
« Last Edit: October 01, 2015, 06:59:40 AM by dennis100 » Logged
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« Reply #20 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
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dennis100
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« Reply #21 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
« Last Edit: October 01, 2015, 07:00:02 AM by dennis100 » Logged
dennis100
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« Reply #22 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
« Last Edit: October 01, 2015, 07:00:19 AM by dennis100 » Logged
dennis100
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« Reply #23 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
« Last Edit: October 01, 2015, 07:00:39 AM by dennis100 » Logged
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« Reply #24 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
« Last Edit: October 01, 2015, 07:00:55 AM by dennis100 » Logged
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« Reply #25 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
« Last Edit: October 01, 2015, 07:01:11 AM by dennis100 » Logged
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« Reply #26 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
« Last Edit: October 01, 2015, 07:01:28 AM by dennis100 » Logged
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« Reply #27 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
« Last Edit: October 01, 2015, 07:01:43 AM by dennis100 » Logged
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« Reply #28 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
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« Reply #29 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
« Last Edit: October 01, 2015, 07:02:00 AM by dennis100 » Logged
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