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Author Topic: Vocal Cord Paresis/Paralysis  (Read 315559 times)
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dennis100
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« Reply #840 on: May 11, 2019, 03:18:39 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury   
Event Description
It was reported that a patient was suffering from dysphonia that started after device implant. Examination by an ent revealed left vocal cord paralysis. Stimulation was noted to not have been turned on yet. Impedance was noted to be ok. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8518669
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dennis100
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« Reply #841 on: May 11, 2019, 03:19:27 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2018
Event Type  Injury   
Event Description
It was reported by the physician that the patient experienced vocal cord paralysis since their vns implant surgery. The patient was referred to an ent. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8493994
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dennis100
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« Reply #842 on: June 07, 2019, 05:36:38 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2008
Event Type  Injury   
Event Description
It was reported that the patient was unable to sing since the vns was originally placed, and that it was found out years later in 2012 that one of the patient¿s vocal cords had been paralyzed. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8574901
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dennis100
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« Reply #843 on: June 07, 2019, 05:37:13 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported by this physician that patient had vocal cord paralysis that "randomly came up. " the patient did not have a change in settings and the physician did not know the reason for the vocal cord paralysis, or the date that it had started. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8573312
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dennis100
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« Reply #844 on: June 07, 2019, 05:37:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/20/2019
Event Type  Injury   
Event Description
The patient reported voice hoarseness from intubation at the first follow up appointment post vns implant surgery. It was also noted that the patient experienced vocal cord paralysis, which the physician reported to be related to the vns implant procedure. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8580843
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dennis100
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« Reply #845 on: June 08, 2019, 06:33:03 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/30/2018
Event Type  Injury   
Event Description
Initial report was that a patient presented with vocal cord paresis that was made worse with stimulation. The patient was referred to an ent. Further information was received from the physician's office. The nurse stated that the patient's symptoms had not improved and that the patient was following up with an ent. The patient was reported to be receiving voice therapy and was doing exercises at home as treatment. The vns device was disabled. It was noted that the paresis has been occurring since device implant and that lead impedance and the battery were ok. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8600341
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dennis100
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« Reply #846 on: June 18, 2019, 12:57:49 AM »

Model Number 302-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/20/2006
Event Type  Injury   
Manufacturer Narrative

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
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dennis100
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« Reply #847 on: June 19, 2019, 04:29:06 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient believed that she was experiencing erratic stimulation from the vns. It was stated that the patient believed the vns battery was possibly going dead. The patient was referred for prophylactic vns generator replacement. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial report inadvertently did not select 'required intervention to prevent permanent impairment/damage. '.
 
Event Description
Follow up with the patient's neurologist revealed that the patient had paralyzed vocal cords on the left side and the vns was disabled, including magnet mode, as a result. The physician stated that she found it strange that the patient developed vocal cord paralysis so long after the vns implantation and queried whether it was a result of a large seizure the patient did not recall. The patient was referred to an ent for further examination. The physician stated that she would like to further analyze the situation with the patient's vocal cord prior to replacing the vns or programming it back on. The physician felt that the vocal cord paralysis may be something unrelated to the vns, but wanted to determine this prior to proceeding further. X-rays were reviewed by the physician and no lead breaks were observed. Diagnostics were reported as fine with no impedance issues. It was reported that the patient underwent full vns explantation surgery. The explanted vns generator and lead have not been received by the manufacturer to date.
 
Event Description
During attempts at product return, it was revealed that the facility, historically, does not return explanted products and would need written consent from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7105104
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dennis100
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« Reply #848 on: June 22, 2019, 03:55:03 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient had vocal cord complications. No additional or relevant information has been received to date.
 
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
"vocal cord complications" was clarified by the nurse to be a left vocal cord paresis, and not paralysis. The vocal cords were noted to be inflamed. The patient was also noted to have difficulty swallowing, trouble breathing and coughing, which the physician had also attributed to the vns surgery. The nurse indicated that the patient's condition was improving. No device malfunctions were noted from device interrogation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7173606
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dennis100
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« Reply #849 on: June 25, 2019, 01:41:55 AM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use 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.
 
Event Description
It was reported that there was no evidence of the vocal cord being nicked on evaluation by the ent. Left vocal cord paralysis (lateral displacement) with left arytenoid cartilage partial collapse. No surgery has occurred to date. If the surgery does occur, it was communicated that it will done for patient comfort only and not to preclude a serious injury. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7282410
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dennis100
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« Reply #850 on: June 25, 2019, 01:42:31 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient has decreased appetite and was diagnosed with right vocal cord paralysis due to vns lead revision surgery. The patient's new device was programmed to the lowest settings following the surgery and diagnostics were reported to be within normal limits. Lead was replaced due to low impedance and this event was reported in mfr. Report # 1644487-2017-04807. The neurologist and ent are closely monitoring patient's progress. The neurologist does believe that vocal cord paralysis may have caused lack of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7280279
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dennis100
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« Reply #851 on: July 05, 2019, 11:37:49 PM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing a sensation of dyspnea while speaking and hoarseness. When seen by otolaryngology, it was noted that the patient has left vocal paresis and had an injection in the vocal fold. It was stated that the patient has had previous neck trauma and had to be trached after an accident due to a seizure, prior to vns placement. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8732750
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dennis100
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« Reply #852 on: July 05, 2019, 11:38:30 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/17/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received stating new that the patient¿s mother was worried about her son. She reported that since having his lead and vns generator replaced the patient has had complications. His complications all started the day of his vns replacement. His voice was very hoarse and they can barely understand him. She did say it may be a little better now. He is coughing much more than he was prior to vns replacement. His cough has progressed to all day, and to the point he dry heaves, and gags. He had lung x-rays but the x-ray came back clear. No pneumonia or anything showing his cough is lung related. He is eating some but not much. She said she is more concerned that he isn¿t hardly able to drink anything. As soon as he drinks, eats, or moves neck, he is coughing, gagging or trying to aspirate. Additional information was received that the adverse events occurred regardless of stimulation being on or off and they all began post operation 2 days after. Anytime he drinks or eats, he begins to cough, like he¿s trying to aspirate. His settings post-op were put on initial settings at the request of neurologist. The device was programmed back on. Patient saw an ent and has vocal cord paralysis on his left side. Most likely cause is the vns procedure. No surgery has occurred to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8697126
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dennis100
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« Reply #853 on: July 11, 2019, 02:17:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient who was recently implanted presented with vocal cord paralysis. Information was received indicating the patient presented a twofold voice causing vagal nerve dysfunction and per the ent the patient has no mobility in the left vocal cord. It was confirmed this is vocal cord paralysis and the patient has not had the device explanted. The device is off as the patient has not recovered and the patient is being taken care of at a facility. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8699480
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dennis100
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« Reply #854 on: July 11, 2019, 02:17:58 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient's device was left off because he had vocal cord paralysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8683217
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dennis100
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« Reply #855 on: July 11, 2019, 02:19:45 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/15/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had dyspnea and voice alteration since implant; however, it got much worse after the patient was intubated november/december 2018. Reportedly, the er had trouble intubating him. He saw his physician to address this issue of worsened dyspnea/voice alteration with the vns after the intubation. The patient reported that he used to be very active but that he now got short of breath when walking a short distance. When he saw his physician, he walked down the hall and it caused him to wheeze badly. His voice was also much more affected than normal by the vns. This had began to occur after the intubation while he was still being titrated. The patient reported that he had seen an ent in (b)(6) 2019 who had told him one of his vocal cords was paralyzed and was "out of place. " the vns was disabled and when the patient walked down the hall, he had wheezing, but it wasn't nearly as bad as when the vns was on. The vns was turned back on at the request of the patient because the patient would rather deal with the shortness of breath and voice alteration rather than seizures. Diagnostics were within normal limits. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8679939
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dennis100
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« Reply #856 on: July 14, 2019, 04:45:01 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient has recurrent paresis /vocal cord paralysis on the left side. The generator was not turned on and the device was not providing stimulation. The paresis/paralysis is suspected to be surgery related as the device had not been turned on.
 
Event Description
Product information was received.
 
Event Description
It was reported that the patient has hoarseness and recurrent palsy/paralysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7783678
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dennis100
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« Reply #857 on: August 10, 2019, 02:37:07 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was referred for generator replacement. Within the clinic notes, information was received that the patient experiences pain related to stimulation in their left neck, chest, and shoulder, as well as pain when their lead is palpated. Additionally, the notes mentioned that the patient suffers from left vocal cord paralysis. The clinic notes detail that the patient experienced shingles, not alleged due to the vns, and that the patient believes the shingles "messed up her device" since the reported pain did not occur until after the patient experienced shingles. Within the clinic notes the surgeon informed that the patient's symptoms and the device are not likely associated, but that the device did need to be assess to ensure that it was not causing other symptoms. It was reported in clinic notes that the device was previously checked, and that the impedance was within normal limits and the physician made no changes to the patient's settings. Additional information was received that the physician indicated that the patient's referral for replacement was due to pain. The neurologist's office indicated that the device removal due to pain is for patient comfort reasons. However, no additional information was received in regards to the vocal cord paralysis, and its relationship to the surgery referral and pain. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8754630
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dennis100
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« Reply #858 on: August 10, 2019, 02:37:44 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/09/2010
Event Type  Injury   
Event Description
It was reported that the patient was referred for a prophylactic vns generator replacement surgery. During the replacement surgery, the surgeon inadvertently cut the lead and a full revision had to be performed. The generator and lead were returned to the manufacturer for evaluation. The majority 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 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 portion 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 portion of the device. Note that since the majority of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The generator performed according to functional specifications. No eri flags were observed during testing. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. It was later reported approximately nine years later via social media comment by the patient¿s mother that the patient experienced vocal cord paralysis following the generator replacement surgery in which the surgeon inadvertently cut the lead and had to perform a full replacement surgery. It was stated that the patient was not able to make any sound and it took almost a year for the patient to be able to talk well. The mother also reported that the device could not be programmed on for almost two years and then had to be adjusted very slowly. Review of the manufacturer's programming history database revealed that the diagnostics were within normal limits for the approximately seven years present in the database. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8795031
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dennis100
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« Reply #859 on: August 10, 2019, 02:38:19 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/22/2019
Event Type  Injury   
Event Description
Patient reported that he lost one half of his voice box after generator replacement surgery. An ent physician informed the patient that half of the voice box (vocal cords) was paralyzed and that the patient was recovering from the event. Further information was received from the patient's physician's office. The cause of the vocal cord paralysis was noted to likely be the patient¿s incubation but it was stated that the cause of the paralysis was still unknown. Lead impedance was noted to be ok on (b)(6) 2019. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8802445
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dennis100
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« Reply #860 on: August 10, 2019, 02:38:52 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/24/2019
Event Type  Injury   
Event Description
It was reported by the health care professional that she had a patient with left vocal cord paralysis and she wondered if it could be related to the vns. It was reported by the medical professional that the onset of the event was unknown. Evaluation was done recently with ent with a scope performed for an unrelated reason; this revealed the left-sided vocal cord paresis. The patient was nonverbal without prior evaluation and so the onset time could not be known. Past several device diagnostics were within normal limits (2393-2406 ohms). The cause of the vocal cord paresis was unknown. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8807826
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« Reply #861 on: August 10, 2019, 02:39:31 AM »

Model Number 300-20
Device Problem Corroded
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
It was reported by the patient that she was experiencing vocal cord paralysis. It was stated that the patient's generator had been removed 16 years previously. An ent informed her that the vocal cord paralysis was due to coil degradation. It was also stated that she had a swollen salivary gland due to cancer (unrelated to vns) that was pressing against the electrodes and causing a pinching pain. The patient wished to have the lead explanted. No relevant surgery 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=8823073
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« Reply #862 on: September 07, 2019, 01:35:38 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
Clinic notes were received as part of the referral process for a prophylactic vns generator change. Within the clinic notes it was reported that the patient has experienced vocal cord paralysis and severe weight loss with the vns therapy system. It was noted that the patient had experienced some voice problems and saw an ent provider who told the patient that they have a paralyzed vocal cord on the left and it may be due to the vagal nerve stimulator. It was mentioned that due to the vocal cord paralysis, the patient has experienced issues choking on liquids. It was noted that since vns implant, the patient has lost a significant amount of weight and went from about (b)(6) pounds down to (b)(6) pounds all occurring during treatment for their brain tumor. At the patient's most recent appointment it was observed that the generator "catches on things in its current location. " the physician discussed the likely need to reposition the generator more medially as he is in agreement that it frequently catches on things in its current location. (generator protrusion has been reported in mfr. Report # 1644487-2019-01619) multiple attempts have been made to the surgeon and physician for additional information on this report; however, no response has been received to date. No known 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=8918266
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« Reply #863 on: September 07, 2019, 01:36:11 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/23/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported vocal cord paralysis alleged to have been caused by the explant procedure is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient has possible vocal cord paralysis following a vns explant procedure. A review of device history records for the patient's lead shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device, but rather the explant procedure itself. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8879360
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« Reply #864 on: September 07, 2019, 01:36:47 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2019
Event Type  Injury   
Event Description
It was reported by the patient that she was told by an ent that she has left sided vocal cord paralysis. The patient was recently implanted with vns. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8937740
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« Reply #865 on: September 07, 2019, 01:37:27 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/24/2019
Event Type  Injury   
Event Description
It was reported that at a patient¿s follow-up appointment post-op, the patient was having a hard time speaking. The vns was not turned on yet. The patient was sent to an ent and it was determined that the patient has vocal cord paralysis. No intervention is planned. The patient reported that after his surgery he lost his voice. He stated that his neurosurgeon asked him to wait for a week to see if it was due to swelling as part of the healing process. He then went to an ent who stated that his left vocal cords have no function whatsoever. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8945848
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