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Author Topic: Vocal Cord Paresis/Paralysis  (Read 307131 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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