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Author Topic: Vocal Cord Paresis/Paralysis  (Read 307613 times)
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dennis100
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« Reply #810 on: March 07, 2019, 02:22:40 AM »

Model Number 304-20
Event Date 04/30/2015
Event Type  Injury   
Event Description
A patient reported she was referred to an ear, nose, and throat (ent) doctor by her neurologist for evaluation of persistent hoarseness. The ent diagnosed the patient with vocal cord paresis/paralysis with the believed cause to be intubation during vns implant surgery. The patient reported that she also experiences choking, some coughing and tingling in the back of her throat. She stated that her voice is improving and she may have to undergo surgical repair. Post-implant medical records obtained from the neurologist indicate that surgery was uncomplicated, that the patient experienced a rough voice afterwards but no swallow dysfunction at that time, and that vns stimulation was well tolerated by the patient. On a subsequent visit it was noted that the patient was concerned that her voice had not come back yet. Vns parameters were increased at the visit and noted to be tolerated well by the patient, and the patient was referred to the ent. Medical records obtained from the ent describe persistent hoarseness starting immediately after vns surgery that has not worsened or improved since surgery, some dysphagia while eating & drinking, and occasional cough. Endoscopic evaluation of her larynx demonstrated left true vocal cord paresis/paralysis that appears to be complete. The ent records stated that the patient wished to continue with periodic observation and not pursue any treatment at this time. The patient was asked to return to the ent in 2 months. No known interventions have occurred to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5105420
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dennis100
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« Reply #811 on: March 08, 2019, 02:03:30 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/23/2018
Event Type  Injury   
Event Description
Article titled "vagus nerve stimulation for the treatment of refractory epilepsy in the cdkl5 deficiency disorder" was reviewed and multiple adverse events were identified for multiple patients with cdkl5 deficiency disorder (which results in a severe epileptic encephalopathy). The following adverse event was reported within the article: 1 patient was admitted to the icu with ventilation support due to severe vocal cord paralysis. Other adverse events within the article are reported in mfr. # 1644487-2019-00211. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8299302
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dennis100
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« Reply #812 on: March 09, 2019, 03:06:06 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2018
Event Type  Injury   
Event Description
That patient reported that her vocal cords were paralyzed during initial device implant surgery. The patient's neurologist believes that patient's condition got better since her last visit, but the patient disagrees. The patient reports that she has had a raspy voice since surgery as well. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8296265
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dennis100
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« Reply #813 on: March 10, 2019, 02:29:50 AM »

Model Number 304-20
Event Date 08/20/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient has experienced vocal cord paralysis since vns implant. The patient was seen by the surgeon who advised the patient to give it some time to see if the condition will resolve itself. It was reported that the generator would not be programmed on for a few weeks. Further follow-up revealed that the surgeon feels that the vocal cord paralysis is either due to manipulation of the nerve during surgery or intubation. The patient appeared to have a cold or unrelated infection which could be related to the vocal cord paralysis. The patient was referred to an ent and prescribed steroids and time. No additional relevant information have been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5098680
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dennis100
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« Reply #814 on: March 10, 2019, 02:30:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
The patient reported that they were having issues with their vocal cord due to vns. The patient indicated that their symptoms were closer to vocal cord paralysis than voice alterations. These symptoms appeared following a recent prophylactic generator replacement surgery. System diagnostics were noted to be within normal limits following the replacement procedure. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8302063
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dennis100
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« Reply #815 on: March 14, 2019, 06:29:48 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 09/24/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 from the patient's mother that the patient was seen on (b)(6) 2015 and the physician indicated that the device wires are either disconnected or broken. The sales representative was able to see the patient on (b)(6) 2015 right after the report and interrogated the device and found that she did have high impedance >10,000 ohms. Upon examination of the x-rays it appeared that the pin was not past the connector block. She noted that the x-rays were very large and the only copy and she was not allowed to obtain a copy. The physician plans to revise as soon as possible. Although surgery is likely it has not occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported in (b)(6) 2015 that the patient was in surgery and the lead pin was reinserted but this did not resolve the high impedance issue. The patient is scheduled for lead replacement although this has not occurred to date.
 
Event Description
It was reported that the surgeon never opened the patient's neck to visualize the lead. He stated that there was too much scarring and he didn¿t have time to revise the lead. It was assumed that the lead would be scarred in during the next replacement. The surgeon decided that he wants to do a right sided implant a next times a result of the incision scarring. It was reported on 01/19/2016 that the patient¿s neurosurgeon is referring her to an ent to assess right and left side paralysis of the vocal cords. The neurosurgeon¿s plan is to re-implant the vns on the right side. The relationship of the vocal cord paralysis and high impedance is unknown.
 
Event Description
The patient still has not seen the ent to evaluate the vocal cord paralysis, therefore at this time there is no confirmation of the reported vocal cord paralysis. The physician wants the ent to evaluate the right side for vocal cord paralysis since he wants to put the electrodes on the right side.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016 due to high impedance. The explanted devices were discarded due to hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5162668
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dennis100
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« Reply #816 on: March 19, 2019, 01:38:47 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 12/10/2014
Event Type  Injury   
Event Description
It was reported that a patient developed an infection roughly 3 weeks post-implant and was admitted, treated, and discharged from a local hospital. Over the next 4 months the infection repeatedly recurred and was treated with antibiotics. The patient was seen by an infectious disease specialist but no infectious diseases were diagnosed. A physician eventually deemed that the entire vns system should be removed due to the infection and surgical removal of the vns system was performed. Vns function was noted to be normal throughout the implant duration with normal lead impedances observed. The patient may be re-implanted at a later date. The explanted products have not been returned to the manufacturer to date. Review of manufacturing records confirmed that the pulse generator and lead were sterilized prior to distribution. The patient developed vocal cord paresis as a result of the explant procedure (reported in mfr. Rpt. # 644487-2015-05993).
 
Event Description
It was reported that the explanting hospital discarded the explanted devices per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5226603
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dennis100
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« Reply #817 on: March 24, 2019, 03:11:38 AM »

Model Number 304-20
Event Date 09/30/2015
Event Type  Injury   
Event Description
It was reported via clinic notes that patient had vns implanted on (b)(6) 2015 and has since been having complaints of hoarseness and choking. The surgeon did a scope and said the vocal cord was abnormal. The patient was reportedly drinking and eating some, but not all foods due to the dysphagia. Additional information was received that the left vocal cord was only partially paralyzed (paresis), and is improving. Both the paresis and dysphagia are thought to be due to both the implant surgery and vns stimulation. The patient is continually being monitored for these issues, and they are reportedly improving. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5270442
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dennis100
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« Reply #818 on: March 27, 2019, 07:13:05 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a prophylactic generator replacement. It was later reported that the referral was cancelled as the patient visited an ent and has larynx damage, and the ent scope showed too many complications for surgery. It was reported that at a consult with a vascular surgeon, the surgeon told the patient that the patient's inflammation in his larynx is due to the vns, and the patient wanted the device turned off. The patient wanted to test the efficacy to see if he still needed the vns therapy. The device was programmed off on (b)(6) 2015. The patient then reported that he has always had voice issues and hoarseness but did not mention whether it was constant or with stimulation. The patient was scheduled to visit with the implanting vns physician for the voice issues and full revision consult. No additional relevant information has been received to-date. No known surgery has occurred to-date.
 
Event Description
A message was received from the physician's office that the patient was healthy and able to fly with no foreseen problems and was written to inform of the vns placement. Additional relevant clarifying information has not been received to-date.
 
Event Description
Information was received from the physician (b)(4) 2016 providing that the inflammation was not caused by vns. The physician reported the patient developed hoarseness and was found to have a paralyzed vocal cord. However the vns was turned off 3-4 weeks prior with no changes. The vocal cord involved was on the right and the vns is on the left. The physician does not believe the voice alteration was due to stimulation or the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5348388
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dennis100
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« Reply #819 on: April 04, 2019, 01:57:10 AM »

Model Number 106
Event Date 05/13/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that following lead and generator replacement surgery the patient was experiencing almost continuous hoarseness and dysphonia. The physician believed that the patient was suffering from transient vocal cord paresis. The physician reported that the symptoms were related to the recent lead replacement surgery. A system diagnostics test was performed at a follow-up appointment and the results were normal. The patient was evaluated by an ent and it reportedly doing better. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5752448
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dennis100
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« Reply #820 on: April 05, 2019, 10:15:57 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2015
Event Type  Injury   
Event Description
The patient underwent laryngoscopy to assess the patient's vocal cords with the device both on and off. The patient's left vocal cord was noted to be weak prior to implant and had been further weakened by the device. The patient was referred for speech therapy. Further information was received from the patient's treating neurologist. Per the physician, the cause of the vocal cord weakness was unknown. The patient stated during a clinic visit that she has always had a weak vocal cord, but there was no medical diagnosis per records in the physician¿s office. Per the physician, the vocal cord paresis was made worse by vns stimulation. The referral for speech therapy was noted to be for patient comfort only.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8453776
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dennis100
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« Reply #821 on: April 06, 2019, 02:37:55 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2002
Event Type  Malfunction   
Event Description
It was reported by a patient in medwatch mw5083309 that following their vns implant, they lost the use of her vocal cords for over eight months, and had partially lost the use of her vocal cords for many years. This is reported in mfr report #1644487-2019-00429. The patient also reported that their oxygen levels dropped and remained very low. The patient has remained on oxygen since then. The patient also reported that they have been depressed following the implant. They stated that it has been a very serious depression. This is reported in this report, mfr report #1644487-2019-00428. Programming history was reviewed for the patient. The patient¿s device was disabled. No anomalies were seen. Device history records were reviewed for the devices. The devices passed all specifications prior to distribution. Attempts for more information have not been successful to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401427
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dennis100
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« Reply #822 on: April 07, 2019, 03:47:32 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/12/2019
Event Type  Injury   
Event Description
It was reported that a patient involved in the 'core vns' study experienced left vocal cord palsy (paralysis) after vns device implant. The patient was provided medication due to the left vocal cord paralysis. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8403939
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dennis100
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« Reply #823 on: April 07, 2019, 03:48:37 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/13/2019
Event Type  Injury   
Event Description
It was reported that the patient has suffered vocal cord paralysis. The issue is reported to be related to the vns implantation/procedure. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8434089
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dennis100
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« Reply #824 on: April 07, 2019, 03:49:21 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2019
Event Type  Injury   
Event Description
It was reported that the patient was having difficulty speaking and that it was getting worse since initial vns implant. The patient breathless while speaking and so was whispering. His breathing was fine while not talking. The patient's vns was not yet turned on. Diagnostics on implant date were ok. Later, it was determined that the patient had vocal cord palsy, and turning the patient's vns on was delayed. Further information was received reporting that the patient had been speaking normally directly after implant, but his vocal ability began to deteriorate not long after, until he was only able to whisper. It was noted that the patient's condition had recently improved as he was able to speak even if his voice was still gravelly. No further relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8423416
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dennis100
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« Reply #825 on: April 08, 2019, 03:09:40 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Injury   
Event Description
It was reported that the patient underwent a full revision surgery and developed hoarseness after the procedure. The patient was evaluated by an ent specialist and was diagnosed with vocal cord paralysis. The patient also experienced vertigo spells for which the normal output current and autostim output currents were disabled. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8381956
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dennis100
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« Reply #826 on: April 08, 2019, 03:10:15 AM »

Model Number 300-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2002
Event Type  Injury   
Event Description
It was reported by a patient in medwatch mw5083309 that following their vns implant, they lost the use of her vocal cords for over eight months, and had partially lost the use of her vocal cords for many years. This is reported in this report. The patient also reported that their oxygen levels dropped and remained very low. The patient has remained on oxygen since then. The patient also reported that they have been depressed following the implant. They stated that it has been a very serious depression. This is reported in mfr report #1644487-2019-00428. Device history records were reviewed for the devices. The devices passed all specifications prior to distribution. Attempts for more information have not been successful to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401443
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dennis100
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« Reply #827 on: April 08, 2019, 03:10:48 AM »

Model Number 7304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Event Description
It was reported that the patient was diagnosed with paresis of the right vocal cord following vns implant surgery. It was reported that the right vocal cord paralysis was "probably related" to the surgery. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424431
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dennis100
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« Reply #828 on: April 08, 2019, 03:11:31 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/16/2018
Event Type  Injury   
Event Description
The patient had previously underwent a generator explant surgery due to an infection which developed shortly after the generator was implanted. This infection is reported on mfr. Report #1644487-2018-02229. Additional information was received which reported the patient had also developed speech difficulties and trouble swallowing after the implant surgery. It was also reported that the patient¿s swallowing and speech became worse after the device was removed due to the infection. The patient was evaluated by an ent specialist who diagnosed the patient with vocal cord paralysis. The ent's evaluation of the patient determined that, per a laryngoscopy, the left vocal cord was frozen in the paramedian position. Additionally, the patient experienced dysphonia and dysphagia following the vns removal in addition to the diagnosed vocal cord paralysis. The ent was also concerned the patient was aspirating liquids and requested a swallow test. Furthermore, during the swallow test the patient aspirated a small amount of thick liquid. Per the ent's specialist, the vocal cord paralysis is likely associated with the removal surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8381913
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dennis100
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« Reply #829 on: April 13, 2019, 05:02:55 AM »

Model Number 304-20
Event Date 07/25/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the np that the patient is experiencing voice alteration while the device is not stimulating. Patient's voice was normal when vns is stimulating. Patient did undergo a recent full revision surgery where they were likely intubated,. Diagnostically, the output current will be titrated down. The patient will also be told to use the magnet to disable therapy. Per implant card received from surgery on (b)(6) 2016, the impedance was marked ok. Additional information was received that the patient's voice alteration began around (b)(6) 2016. Patient had not experienced voice alteration prior to (b)(6) 2016. The voice alteration did not resolve with decrease in output current settings but vocal symptoms have been slowly improving. Patient's voice is not yet to baseline. The relationship between the voice alteration and vns is unclear as voice improves with stimulation and worsens during off time. The nurse practitioner though that it could possibly be side effect of intubation from recent surgery on (b)(6) 2016. Interventions were taken to preclude a serious injury as opposed to patient comfort additional relevant information has not been received to date.
 
Event Description
Additional information was received that the patient used to experience voice alteration associated with vns stimulation prior to lead revision surgery but now as reverse voice alteration that occurs during vns off time. The hoarseness was reported to be worse in the afternoon. The nurse practitioner attempted to turn down patient's settings and had patient hold the magnet over the device to temporarily disable it, but neither of these helped alleviate the problem. Diagnostics were all ok. Despite different setting adjustments, patient continued to experience the voice hoarseness and was referred to see an ent physician. Patient underwent laryngoscopy exam and flexible endoscopy and no motion in the left vocal cord was visualized. Patient was diagnosed with paralysis of left vocal cord and larynx. Tone improves when the stimulator is on which is why the voice improves but does not allow adduction. The initial diagnosis is that during this patient's lead revision surgery, the recurrent laryngeal nerve was injured. Patient might need more testing and will be referred for speech therapy to work on adduction strengthening of the right cord in the meantime. The ent physician will plan to see patient in 6 months and then consider vocal cord medicalization to help improve voice quality if paralysis persists.
 
Manufacturer Narrative
Evaluation codes, method: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
It was later reported the patient had a follow-up visit and it was stated the patient is on a "path to full recover" and that there was clear improvement in the patient's voice when the device was not stimulating. The patient's voice continued to sound better when the vns was providing stimulation. No changes were made to the patient's settings and the patient's family is elated with how much improvement they have seen.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5908032
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dennis100
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« Reply #830 on: April 15, 2019, 01:48:23 AM »

Model Number 304-20
Event Date 02/29/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing voice alteration and dyspnea described as "almost asthma-like symptoms. " the patient's treating neurologist referred the patient to an ent physician for evaluation. The ent physician showed that the patient had left vocal cord paralysis. Previously, the patient's vns system had been disabled for 2 months for an evaluation period leading up to the ent appointment. The voice alteration and dyspnea continued in this trail period. Furthermore, it was clarified that the voice alteration began soon after surgery. The patient's treating physicians determined that the vocal cord paralysis and associated voice alteration and dyspnea were related to the patient's vns implant surgery. The patient was stated at that time to be planning to undergo speech therapy to mitigate the effects of the vocal cord paralysis. The patient's device was re-enabled. Device diagnostics were reported to be within normal limits from surgery through the date of this report. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980975&pc=LYJ
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« Reply #831 on: April 17, 2019, 07:19:45 AM »

Model Number 300-30
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on vns patient's system. It was reported that the patient was to undergo generator replacement surgery, when high impedance was observed. In or, the patient's vns system was tested upon connection of the new generator to the existing lead and system diagnostics returned impedance results within normal limits. The physician decided then to close the patient and wait. Further information indicated that impedance tests were run the day after the surgery and high impedance was found again. No patient adverse events were reported. It was reported that lead revision is planned. No known surgical interventions have been performed to date.
 
Event Description
Additional information was received through an implant card indicating that the patient underwent full revision surgery on (b)(6) 2016. The explanted devices are not available for the return to the manufacturer for the analysis. It was reported that the generator was replaced due to the incompatibility with the new implanted lead model. It was reported that the patient is doing well after the replacement surgery.
 
Event Description
New information was received that the patient was implanted on the right vagus nerve. The patient is now having paralysis of the vocal cord. The vocal cord paralysis is reported in mfr. Report # 1644487-2016-02082.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5952365
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dennis100
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« Reply #832 on: April 24, 2019, 03:01:21 AM »

Model Number 103
Event Date 01/01/2015
Event Type  Injury   
Event Description
An article titled ¿the role of laryngeal electromyography in vagus nerve stimulation-related vocal fold dysmotility"¿ was published in 2016. All participants in the study had been implanted with a vns device for 2-5 years and reported experiencing mild to severe hoarseness. During the study the patient's throat muscles were evaluated during stimulation off times and on times using electromyography and endoscopy. The article reported that during the study it was determined that 2 of the patients were suffering from vocal cord palsy. No additional relevant information has been received to date. Manufacturer report # 1644487-2016-02880 captures patient #1 who had experienced vocal cord paresis with and without vns stimulation. This report captures patient #2 who had experienced vocal cord paresis without vns stimulation however experienced forced adduction during vns stimulation. It was noted that during vns stimulation off times the patient's muscles exhibited tonic spastic activity during breathing with reduced phasic modulation during phonation. These symptoms were not modified during vns stimulation on times. When vns stimulation was occurring the patient was experiencing forced adduction. Following the forced adduction the patient experienced muscle spasms in the thyroarytenoid and cricothyroid muscles for about 5 seconds following vns stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6182583
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dennis100
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« Reply #833 on: May 06, 2019, 05:24:06 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported by a patient through a company representative that the patient's generator suture in the chest pocket had broken loose. The event happened when the patient was laying down on the ground and had a dog jump on her chest. The patient's treating neurologist performed diagnostics on the patient's device and were within normal limits (no specifics). Moreover with movement, the patient has vocal cord paralysis and possibly due to the strain of the lead pulling on the nerve. Per the patient, she has to manually hold the generator in the pocket by herself. Also, if the patient looks upward she coughs because of the weight of the device pulling on the nerve. Patient is scheduled to see the surgeon for evaluation. Additional information was received from a company representative indicating the patient underwent revision surgery. Upon surgery, the lead was twisted and pulled tension on neck; the strain relief was broken as well. The surgeon placed new pocket in chest above old pocket and sutured to fascia. He then recreated strain loop in neck. Currently, the patient called and said she is no longer feeling need to vomit or cough with neck movement. No new lead or generator was needed. Stimulation was not turned on. Patient still has vocal cord paralysis from this event so her treating physician will determine when vns will be programmed on. Mfr. Report #1644487-2010-02742 was submitted to report on the event of vocal cord paralysis. Moreover, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919363
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dennis100
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« Reply #834 on: May 08, 2019, 10:42:37 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2017
Event Type  Injury   
Event Description
It was reported that the patient¿s vns had caused vocal cord dysfunction. No further information on this report could be clarified at the time of the initial report. Follow up with the office of the treating neurologist showed that the patient¿s vns registered system impedance within normal limits. No further information could be provided at that time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6535831
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dennis100
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« Reply #835 on: May 08, 2019, 10:43:18 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2016
Event Type  Injury   
Event Description
Information was received indicating that the patient's voice was "extremely" hoarse. The hoarseness was not cyclical but constant. The patient was referred to an ent for injects. The hoarseness was present after the patient's implantation surgery in (b)(6) 2016 where the patient's generator was programed on. The patient's generator was disabled in february to allow the patient to heal. Diagnostics of the patient's device were within normal limits. No additional relevant information has been received to date.
 
Event Description
It was later explained by the physician that the patient's voice was hoarse and getting progressively worse, along with coughing and aspiration of both solids and liquids. It was also explained the patient has left vocal cord paresis as opposed to paralysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6378738
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dennis100
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« Reply #836 on: May 11, 2019, 03:15:00 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2019
Event Type  Injury   
Event Description
After device implant the patient reported hoarseness and shortness of breath. An ent specialist diagnosed the patient with vocal cord paralysis. The patient's treating physician indicated that the events were related to vns surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514461
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dennis100
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« Reply #837 on: May 11, 2019, 03:16:28 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/03/2017
Event Type  Injury   
Event Description
The physician reported that a patient suffered vocal cord paralysis following a previous lead revision surgery. The physician noted that the patient ended up having a device implanted to help their voice, and informed that the vns was turned off for several months following the vocal cord paralysis onset. The physician has recently programmed the vns back on to very low settings. The physician attributed the vocal cord paralysis to the vns lead revision surgery, noting that the patient's nerve was possibly nicked during the procedure. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8471259
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dennis100
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« Reply #838 on: May 11, 2019, 03:17:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/04/2019
Event Type  Injury   
Event Description
It was reported by the patient that their generator pocket had ripped and the generator was lower than it should be following the patient lifting a heavy object. The patient reported that when they went under an overpass they believed the magnetic force of the wires in the overpass caused paralysis of their vocal cords, caused their lead wire to become taut, pain in neck, and their voice to become hoarse. The patient indicated that their neck was bruised and swollen from the stimulation that occurred due to the overpass and felt like their leads were going to come out of their neck. The surgeon's office indicated that the entirety of the reported adverse events experienced by the patient were related to the migration of the generator. It was reported that the generator was secured during initial implant surgery using a "butterfly wing" suture technique; however, the type of suture was not known. It was reported that the patient was referred for a pocket adjustment. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8562974
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dennis100
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« Reply #839 on: May 11, 2019, 03:17:54 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/20/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The abstract of an article was received which studied vagus nerve stimulation treatment in 14 children with pharmaco-resistant epilepsy specific to a single facility. One patient experienced a post-implant complication of unilateral vocal-cord palsy which was stated to be to vns surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506591
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