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Author Topic: Vocal Cord Paresis/Paralysis  (Read 263340 times)
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dennis100
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« on: July 24, 2010, 01:36:13 AM »

Model Number 102
Event Date 07/10/2014
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s bradycardia was not believed to be related to vns. The patient had viral gastroenteritis that led to emesis and issues sleeping, resulting in bradycardia. The patient did not have any prior history or family history of cardiac events nor any pre-existing medical conditions. Prior to the bradycardia, the patient¿s heart rate and blood pressure were approximately 60 bpm and 130/70 mm hg, respectively. During the event, they decreased to 130 bpm and 120/70 mm hg. The event did not occur along with diagnostic tests or with any changes to device settings or medications. No interventions were taken. The patient was hospitalized for monitoring. It was noted that the patient had vocal cord paralysis since being implanted on (b)(6) 2004 and that he was unable to tolerate an output current greater than 0. 5ma.

Event Description
It was reported that the patient was admitted to the hospital with bradycardia in the 40s bpm. The physician wants to rule out the vns as a trigger. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4051930
« Last Edit: September 01, 2018, 01:25:55 AM by dennis100 » Logged
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« Reply #1 on: July 24, 2010, 01:37:27 AM »

Event Date 12/12/2000
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Device has been programmed to "on" and hoarseness is reported to be better.

Manufacturer Narrative
The reporter indicated that they will wait one more month and then likely activate the stimulator. The following dates are estimated. Only the month/year is known: b. 3, date of event. D. 7, implant date.

Event Description
The reporter indicated that the pt developed left vocal cord paralysis following a "vns" implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=323235
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« Reply #2 on: July 24, 2010, 01:38:36 AM »

Event Date 01/31/2001
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Patient reported to have recovered. Vocal cord paralysis reported as resolved.

Event Description
Patient developed vocal cord paralysis 2 days post implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=319597

« Last Edit: December 08, 2016, 03:39:15 PM by dennis100 » Logged
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« Reply #3 on: July 24, 2010, 01:39:49 AM »

Event Date 01/27/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Patient developed severe hoarseness 3 days post implant. Patient was later diagnosed with vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=319890

« Last Edit: December 08, 2016, 03:39:44 PM by dennis100 » Logged
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« Reply #4 on: July 24, 2010, 01:42:15 AM »

Event Date 11/17/2000
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
The pt was last seen by physician on 5/3/2001 at which time the pt continued to suffer from left vocal cord paralysis. The physician recommended that the pt undergo medialization of thyroid plasty. The pt has not contacted physician to set up treatment for vocal cord paralysis.

Manufacturer Narrative
Pt's symptoms have improved, but not resolved. Patient's device was activated 01/02/2001.

Event Description
Patient experienced dysphagia and voice alteration immediately after surgery. The patient was later diagnosed with vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=319907
« Last Edit: December 08, 2016, 03:40:22 PM by dennis100 » Logged
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« Reply #5 on: July 24, 2010, 01:44:09 AM »

Event Date 01/22/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Further investigation revealed that the pt is doing better,however,the vocal cord paralysis has not resolved ocmpletely. The device remains programmed off.

Event Description
Patient diagnosed with vocal cord paralysis.

Manufacturer Narrative
Further f/u on 8/21/01 indicated that the ent surgeon is going to perform an operation to take the lead off the nerve, but leave it implanted. The hoarseness is better; however the pt still has vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=319910

« Last Edit: December 08, 2016, 03:40:51 PM by dennis100 » Logged
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« Reply #6 on: July 24, 2010, 01:46:32 AM »

Event Date 04/07/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt was hoarse after implant, but that voice returned to normal 2 days post-operative. On the afternoon of post-op day 2, the pt was involved in a car accident where pt was rear-ended. Pt's head was twisted to the left and then quickly back to the right. It was reported that the pt had 10 seizures at the accident scene and stopped breathing. Pt was revived and has had numbness ever since in their neck and jaw. Pt also became hoarse again. Device was not programmed to on. Pt was referred to ear nose and throat who confirmed vocal cord paralysis. The device was programmed to on 4/2001, after the diagnosis of vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=337642

« Last Edit: December 08, 2016, 03:41:22 PM by dennis100 » Logged
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« Reply #7 on: July 24, 2010, 01:47:52 AM »

Event Date 03/16/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Late report due to administrative error. No intervention taken. Further investigation revealed that voice has returned and "is almost normal".

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: December 08, 2016, 03:41:59 PM by dennis100 » Logged
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« Reply #8 on: July 24, 2010, 01:49:26 AM »

Event Date 04/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Patient diagnosed with vocal cord paralysis. Device currently programmed to off. Further investigation revealed that the pt had a benign tumor on their thyroid gland. Surgery is planned to remove the tumor and the device will be turned back on but to lower settings.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=334257
« Last Edit: December 08, 2016, 03:42:30 PM by dennis100 » Logged
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« Reply #9 on: July 24, 2010, 01:50:51 AM »

Model Number 300
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt developed vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=333667
« Last Edit: December 08, 2016, 03:43:51 PM by dennis100 » Logged
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« Reply #10 on: July 24, 2010, 01:52:19 AM »

Event Date 03/01/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
The following dates are estimated. Only the month/year is known. B. 3, date of event.

Event Description
Reporter indicated that the pt has developed partial left vocal cord paralysis and stridor and had an episode of increased saliva where the pt choked. Vocal cord paralysis has improved since device has been turned off for a couple of weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=330396
« Last Edit: December 08, 2016, 03:43:33 PM by dennis100 » Logged
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« Reply #11 on: July 24, 2010, 01:53:49 AM »

Event Date 06/01/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Attempts to obtain additional information have been unsuccessful.

Event Description
Reporter indicated that patient developed severe hoarseness after explant. Vocal cord paralysis was diagnosed by ent. While implanted, the patient only had minimal hoarseness with the device when it was stimulating. The device remained programmed to off most of the time that it was implanted because the patient did not like the feeling of the stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=342176

« Last Edit: December 08, 2016, 03:44:23 PM by dennis100 » Logged
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« Reply #12 on: July 24, 2010, 01:55:26 AM »

Event Date 07/24/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that immediately post-operatively the pt presented with constant hoarseness. The neurologist referred the pt to an ent physician for a confirmed diagnosis of vocal cord paralysis. Stimulation therapy was started approx two weeks post-operatively. The device was programmed to 0. 25/250/20/30/5 and remains at these parameters. The surgeon indicated that he did not believe that programming the device to on before the hoarseness was resolved has worsened the patient's condition. Further investigation revealed that the pt was seen by the neurologist at the beginning of 09/2001 and the hoarseness appeared to be improving. The pt is non-verbal, however the parents felt that the pt may be suffering from vocal cord paralysis because they weren't talking as much. Vocal cord paralysis has not been confirmed. Attempts to obtain add'l info have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=357590
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« Reply #13 on: July 24, 2010, 01:57:12 AM »

Event Date 07/01/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Further follow-up with the physician indicated that the hoarseness has resolved after turning off the vns for a period of 3 to 4 weeks. However, the pt's seizures have doubled in frequency and worsened in severity. The vns was re-activated on 12/02/2001 with no difficulties.

Event Description
Reporter indicated that pt presented with constant hoarseness post-operatively. The device was programmed to on the same day as implant. It was reported that the pt's hoarseness and voice is much worse when talking with their head turned to the left and straight ahead. Left vocal cord paralysis has since been diagnosed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=356716
« Last Edit: December 08, 2016, 03:46:52 PM by dennis100 » Logged
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« Reply #14 on: July 24, 2010, 01:58:17 AM »

Event Date 07/18/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
At 12/20/01 follow-up visit, physician indicated that the vocal cord paralysis has virtually disappeared with an injection of gelfoam. The pt reported two brief complex partial seizures since 10/24/01. Physician recommended that the pt continued medications as prescribed and follow-up in two months for a possible parameter adjustment. The pt reported that she did not want to program the vns to off while waiting for the vocal cord paralysis to resolve since she was already receiving seizure control with the vns therapy. Attempts to obtain device programming history have been unsuccessful to date.

Event Description
Reporter indicated that after implant surgery, with the device still programmed to off, the patient complained of hoarseness and coughing. About three weeks later at an office visit the device was programmed to on. The coughing and hoarseness was improving and did not get worse when programmed to on. The patient stated that could not feel the stimulation (neither normal mode nor magnet mode). Further investigation revealed that the patient was later diagnosed with vocal cord paralysis.

Manufacturer Narrative
Further follow-up revealed that the pt's vocal cord paralysis has resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=353702
« Last Edit: December 08, 2016, 03:47:29 PM by dennis100 » Logged
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« Reply #15 on: October 09, 2010, 11:51:45 AM »

Event Date 10/25/2001
Event Type Injury 
Patient Outcome Disability;
Event Description
Reporter indicated that pt had hoarseness after implant surgery. The hoarseness was described as constant but not severe. Device was not yet programmed to on. Further investigation revealed that vocal cord paralysis had been diagnosed, however, the physician stated that the pt's hoarseness was 80% resolved. The device had been programmed to on. The hoarseness was described as still being constant (not directly related to stimulation events). Steroids had been prescribed to treat the vocal cord paralysis. Attempts to obtain additional info have been unsuccessful.

Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=362275

 
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« Reply #16 on: May 05, 2011, 03:10:54 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.

Manufacturer Narrative
This report is a duplicate of a previously submitted report. This event was previously reported under mfr. Report number 1644487-2001-00522.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=363399
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« Reply #17 on: May 05, 2011, 03:11:32 AM »

Event Date 01/22/2001
Event Type Injury
Patient Outcome Life Threatening; Disability Other
Event Description
In 2001 rptr had a vagus nerve implanted for control of epilepsy. When rptr came out of the surgery rptr had a paralyzed left vocal cord, no sense of smell, or taste, deep inner ear nerve pain and head aches constantly. Has had their air intake and has to sit up in bed so not to aspirate. They cannot do a thing, rptr has to deal with this the rest of life. The drs could not turn the device on because of rptr's problem. They took the vagus nerve stimulator out 8 mos later. Rptr does not know if it was caused by the device or not, but others should be told before they make the decision to have the surgery and end up like the rptr. Such a device should be looked into.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=380583

« Last Edit: December 08, 2016, 03:49:39 PM by dennis100 » Logged
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« Reply #18 on: May 05, 2011, 03:12:14 AM »

Event Date 12/21/2001
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Further follow-up revealed that the pt was seen by an ear, nose, throat and was diagnosed with left vocal cord paralysis. The ent also recommended that the pt start speech therapy. The ent decided that the hoarseness was very possibly a complication of the surgery and felt that spontaneous recovery would or would not occur regardless of initiating the stimulation in gradual increments. Further follow-up also revealed that the pt has been doing very well, with remarkable improvement with his vocal cord paralysis. The physician's nurse reported that at the pt's last visit they noted movement on his left side and they were able to turn up the pt's device settings.

Manufacturer Narrative
Reviewed mfg records. Review of mfg records reveal no anomalies that would have an adverse effect on device performance.

Event Description
Rptr indicated that the pt experienced extreme hoarseness since implant. The device was programmed on as it has not progressed, nor resolved. Further investigation revealed that this was the surgeon's first surgery. The pt was seen by an ent, but diagnosis has not been provided. The physician has decided against recommendations to temporarily discontinue therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=377588
« Last Edit: December 08, 2016, 03:50:48 PM by dennis100 » Logged
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« Reply #19 on: May 05, 2011, 03:12:49 AM »

Event Date 01/01/1999
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Reviewed mfg records. Review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the year is known: b. 3, date of event.

Event Description
Pt said that pt has had vocal cord paralysis for 2. 5 years. Also, the pt wanted the device implanted under pt's armpit and the surgeon implanted the device in pt's chest area. When pt woke up from surgery, pt had no voice and could not breathe. Pt has been to an ent a few times and the ent said that the right vocal cord is compensating. No intervention was taken by the ent. Pt's device has been turned on and off multiple times in the past 2. 5 years, but pt received best seizure control when it was off. An attmept has been made to obtain add'l info via federal express letter to physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=377656

« Last Edit: December 08, 2016, 03:51:31 PM by dennis100 » Logged
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« Reply #20 on: May 05, 2011, 03:14:51 AM »

Event Date 05/21/2002
Event Type Injury
Patient Outcome Disability; Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt does not have vocal cord paralysis and is asymptomatic.

Event Description
Reporter indicated that the pt may have vocal cord paralysis. Surgeon has recommended that the pt be evaluated by an ent to confirm as it is believed that symptoms may be related to manipulation of the vagus nerve during implant surgery. The pt's device was programmed to off upon first complaint (date unk). Two attempts (one writing and one via phone) have been made to gather more info regarding this event; however, no info has been received to date.

Manufacturer Narrative
The labeling for the ncp pulse generator lists left vocal cord paralysis as a potential adverse event associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403252
« Last Edit: December 08, 2016, 03:52:25 PM by dennis100 » Logged
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« Reply #21 on: May 05, 2011, 03:15:40 AM »

Event Date 05/01/2002
Event Type Injury
Patient Outcome Disability;
Event Description
The reporter indicated that the patient was implanted with the vns in 2002 and the device was activated the following day. The patient was diagnosed with vocal cord paralysis the following month. The physician plans no intervention to treat the vocal cord paralysis. The patient is experiencing chronic hoarseness, coughing, and reflux. The patient was seen by a speech therapist. The device settings have been increased and the patient has experienced a small decrease in their seizures. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=399127

« Last Edit: December 08, 2016, 03:52:58 PM by dennis100 » Logged
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« Reply #22 on: May 05, 2011, 03:16:27 AM »

Event Date 01/01/1999
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Disability Required Intervention
Event Description
In the process of contacting the patient to inform them that their generator may be nearing end of service, it was discovered that the patient's ncp system was explanted due to increased seizures and left vocal cord paralysis. It was reported that the explant took place not long after the device was implanted. Reporter indicated that the patient had a short neck and that there was a problem placing the leads initially. It was also reported that the patient's neurologist kept "turning up the device" too high causing left side of the patient's face to twitch followed by choking and coughing when swallowing. It was reported that the ear, nose, throat who explanted the device felt that the high setting was the cause of the vocal cord paralysis. It was reported that the patient continues to suffer from the vocal cord problems. Further follow-up revealed that the patient's lead was replaced in 1999 and that the explant of the ncp system took place after that time (date unknown). Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=395764
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« Reply #23 on: June 28, 2011, 02:59:58 PM »

Event Date 01/01/2011
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the patient was recently experiencing left side vocal cord paralysis. The reporter states the patient is doing so well on vns that the patient's mother and the patient do not want to make any changes to the treatment. It was also reported that the physician does not think it is much of an issue. The patient is currently set to 1. 25 ma and no changes have been made to these settings. Patient has been referred to an ent specialist for a second opinion. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2044942

« Last Edit: December 08, 2016, 03:54:35 PM by dennis100 » Logged
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« Reply #24 on: July 07, 2011, 02:28:51 AM »

Event Date 07/03/2002
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Further follow revealed that the patient was seen by the physician on 08/12/02 and the physician reported that the patient had a marked improvement in voice quality. The physician indicated that the patient's hoarseness has resolved.

Manufacturer Narrative
H. 6: the labeling for the ncp pulse generator lists left vocal cord paralysis as a potential adverse event associated with surgery or stimulation.

Event Description
Reporter indicated that pt has experienced constant hoarseness since vns implant. Investigation to date has been unable to determine whether or not the pt has been diagnosed with vocal cord paralysis. The pt's neurologist has referred the pt to the implanting surgeon for f/u. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=409851

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« Reply #25 on: July 07, 2011, 02:29:36 AM »

Event Date 06/21/2002
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that patient was diagnosed with vocal cord paralysis. The implant surgery was long and there were difficulties locating the vagus nerve. An ear, nose, throat examined the patient while the patient was still in the or and diagnosed vocal cord paralysis. The generator has not yet been programmed to on.

Manufacturer Narrative
Conclusion: the labeling for the ncp pulse generator lists left vocal cord paralysis as a potential adverse event associated with surgery or stimulation.

Manufacturer Narrative
Further follow up revealed that the patient's vocal cord paralysis has resolved. The patient plans to have the ncp system programmed to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=406398
« Last Edit: December 08, 2016, 03:55:38 PM by dennis100 » Logged
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« Reply #26 on: July 07, 2011, 02:31:31 AM »

Event Date 04/01/2002
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Conclusions: left vocal cord paralysis is listed in the product labeling as a potential adverse event possibly associated with surgery or stimulation. Additionally, product labeling precautions state not to program the device to on for at least 14 days following implant surgery.

Event Description
Reporter indicated that pt experienced constant hoarseness following vns surgery and was later diagnosed with vocal cord paralysis by an ear, nose & throat. The pt's ncp system was programmed to on the same day as implant. The pt is reportedly seizure-free. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=404519

« Last Edit: December 08, 2016, 03:56:06 PM by dennis100 » Logged
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« Reply #27 on: July 18, 2011, 02:11:57 AM »

Event Date 05/01/2002
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Further follow- up revealed that the patient's condition has not worsened with parameter increases. The patient was seen by an ent and was told that the left vocal cord was not moving. The ent has a scope planned. The patient reports that the voice hoarseness "comes and goes".

Manufacturer Narrative
Method: device programming history was reviewed. Results: review of device programming history did not reveal any anomalies nor abnormalities. Conclusions: labeling for the ncp pulse generator lists left vocal cord paralysis as a potential adverse event associated with surgery or stimulation.

Event Description
Reporter indicated that the pt has experienced constant hoarseness since vns implant and that the physician has ruled it to be partial or complete vocal cord paralysis. Reporter indicated that the pt is experiencing a decrease in seizure activity since initiating stimulation on 5/2002. Attempts to obtain additional info have been unsuccessful to date.

Manufacturer Narrative
Further follow up revealed that the patient was seen by the physician on 10/16/02 and is reported to be doing well. The ent did not perform a scope as planned since the patient's condition was improving. The physician indicated that the patient's hoarseness has resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403637

« Last Edit: December 08, 2016, 03:56:38 PM by dennis100 » Logged
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« Reply #28 on: July 18, 2011, 02:13:02 AM »

Event Date 01/01/2001
Event Type Injury
Patient Outcome Life Threatening; Disability
Manufacturer Narrative
Conclusions: the labeling for the ncp pulse generator lists left vocal cord paralysis as a potential adverse event associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt suffers from vocal cord paralysis and significant swallowing problems since implant. It was reported that the pt has not received benefit from the vns therapy, but that parameter adjustments continue to be made in hopes of gaining seizure control. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403653
« Last Edit: December 08, 2016, 03:57:10 PM by dennis100 » Logged
dennis100
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« Reply #29 on: July 18, 2011, 02:13:43 AM »

Event Date 01/13/2002
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Conclusion: left vocal cord paralysis is listed in the product labeling as a potential adverse event possibly associated with surgery or stimulation.

Event Description
The reporter indicated that the pt was diagnosed with complete left vocal cord paralysis by an ear, nose and throat physician. The device had not yet been programmed to on. Further follow-up revealed that the pt's voice had returned to normal on 2/2002. The pt's device was programmed to on in 02/2002. The pt was last seen by neurologist on 2/2002 and is reportedly doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403710
« Last Edit: December 08, 2016, 03:57:43 PM by dennis100 » Logged
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