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dennis100
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« Reply #30 on: January 17, 2019, 03:03:58 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient was referred for surgical consult due to dysphonia. The patient experienced a significant deterioration in voice quality following vns implant on (b)(6) 2011. Upon examination using a flexible fiberoptic, it was noted that the patient had periodic hyper-adduction of the left vocal cord. The left arytenoid excessively rotated medially preventing the right vocal fold from closing appropriately which caused the deterioration in voice quality. During stimulation off times, the vocal fold would return to midline position but did not move normally. When the device was disabled using the magnet, the phenomenon would stop. The surgeon stated that the event was due to vns stimulation. Laryngeal adductor botox administration improved the patient¿s symptoms but did not eliminate them. The patient was taken to the or to cut the recurrent laryngeal nerve by performing an ansa to rln reinnervation.
 
Event Description
It was reported that the patient indicated that he was to undergo neck surgery due to laryngeal nerve damage from vns. It was reported that the patient was experiencing laryngeal spasms post vns implant. The surgeon indicated that the patient experienced "unusual vocal spasms during device stimulation"; however, no specific details were provided. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3887010
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dennis100
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« Reply #31 on: January 21, 2019, 11:56:07 AM »

Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".
 
Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.
 
Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.
 
Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167236
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dennis100
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« Reply #32 on: January 21, 2019, 11:57:10 AM »

Model Number 101
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Notes dated (b)(6) 2013 indicated that the patient may have had a seizure on (b)(6) 2013. The device was interrogated at 1. 75/20/130/30/5/1. 75/30. The impedance was ok (dcdc=3), the output status was ok, and the battery was noted to be functioning well. Notes dated (b)(6) 2013 indicated that the patient presented with a 2 year history of voice changes and hoarseness. The patient did not experienced any hoarseness following vns implant, except when it fires. A flexible videostroboscopy was performed with mild atrophy and supraglottic contraction but otherwise normal results. The event was determined to be muscle tension dysphonia for which the patient was referred for speech therapy. Clinic notes dated (b)(6) 2013 stated that the patient felt that her device was no longer working. The patient had three grandma seizures during the year. Prior to that, the patient had not had any seizures in 12 years. The patient also noted that her voice felt weak at times and thought the events might be related. A flexible laryngoscopy was performed: bot, vallecula, and piriform sinuses were clear and normal. Both true vocal cords showed good mobility, but there was possible slight bowing with a 1 mm gap. Moderate arytenoid erythema and mild edema were present. It was reported that the patient has possible mild age related atrophy and mild laryngitis contributing to her voice changes. The patient was referred for generator revision. The vns generator replacement was performed on (b)(6) 2014. The explanted vns device was discarded and therefore cannot be returned. Attempts are being made for additional information; however, no other information has been provided.
 
Event Description
It was reported that the generator battery was dying and the patient experienced more seizures. The physician reported that the patient is doing much better since generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606821
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dennis100
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« Reply #33 on: February 08, 2019, 01:15:13 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via social media that the vns caused the patient to have cysts on her thyroid and that the vns put a lot of pressure on her voice box and thyroid. She reported that she had her thyroid removed a month prior. The vns was explanted due to unrelated reasons prior to the thyroid removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8294394
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dennis100
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« Reply #34 on: February 09, 2019, 03:37:19 AM »

Model Number 101 NCP PULSE GENERATOR
Event Type  Injury   
Event Description
Was implanted with cyberonics vns. They put in a recalled device and the //ong model. It would not stop going on and very quickly caused dramatic problems. I lost use of my vocal cords for over 8 months and then partially for many years, and began having laryngo spasms many times a day. After a long time, they have finally lessened a lot but still occur. They are quite terrifying as my throat is completely closed when they happen. No air can get in or out. Also, my oxygen levels dropped and stayed low, very low, and have remained on oxygen ever since. Was a straight a student moving through a doctoral program but could not complete due to inability to think and organize logically. I was always a very joyful person, but since the implant, i fight depression every day. Sometimes very serious depression, i was always interested in everything. Since the surgery, i mostly wait to die. It's been years since the device was implanted but it has taken this long to fight my way back to enough health to know to make this complaint. I can't take legal action because within the legal time limits i was fighting for my life and could not act. One of their neurosurgeons told me later that i was never a candidate for the implant and that i was nothing more than a customer to them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8273950
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dennis100
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« Reply #35 on: February 12, 2019, 03:25:39 AM »

Model Number 304-20
Event Date 11/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient visited an ent due to difficulty swallowing following surgery and was diagnosed with left laryngeal paralysis. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535913
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dennis100
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« Reply #36 on: March 21, 2019, 01:28:08 AM »

Model Number 302-20
Device Problem High impedance
Event Date 09/03/2015
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system. It was reported that the patient, who had good seizure control with the vns, experienced an increase in seizures and pain around his voice box. The patient was seen to the clinic on (b)(6) 2015 where his device was interrogated and showed high lead impedance. It was reported that the device was switched off. X-rays were taken but no obvious lead break was seen. Those x-rays were not sent to the manufacturer for review. It was reported that the device was again interrogated on (b)(6) 2015 and high impedance results persisted (>=10000 ohms). The device was then left switched off. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. No known surgical interventions have been performed to date.
 
Event Description
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. The suspect lead was explanted and a replacement lead was implanted. No additional relevant information was provided to date.
 
Event Description
Further information was received from a nurse indicating that the explanted lead was discarded by the facility. Therefore, analysis cannot be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5204037
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dennis100
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« Reply #37 on: March 27, 2019, 07:10:40 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 #38 on: March 28, 2019, 08:12:48 AM »

Model Number 304-20
Event Date 01/21/2016
Event Type  Malfunction   
Manufacturer Narrative
Suspect device udi#: (b)(4).
 
Event Description
It was reported by the physician that the patient developed twitching in her neck with the use of the vns magnet. The physician suspects the twitching is due to a lead fracture and has advised the patient not to use the magnet as the patient has no other symptoms and the normal vns output current is not causing the same symptoms as magnet use. Settings were adjusted due to the discomfort with the magnet stimulation, which occurred prior to the observance of the muscle twitching. No settings were changed due to the reported muscle twitching.
 
Event Description
The patient underwent vns explant surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted products.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #1 inadvertently left out information. (b)(4).
 
Event Description
Clinic notes were received by the manufacturer and indicated that the patient had difficulties with pain at the neck and chest where the vns was implanted. It was stated that she developed issues with tension at the neck when trying to do sit-ups. When the vns activated, she experienced contractions of the laryngeal musculature. The patient reported twitching in her neck muscles with magnet stimulation. The vns magnet mode was programmed off. It was stated that since the magnet mode was disabled, the patient was getting the warning for complex partial seizures for shorter lengths of time, which she did not get before. The operative notes from the initial implant were included and no complications were reported. It was noted that the lead was secured to the surrounding subcutaneous tissues with 4-0 sutures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5453369
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dennis100
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« Reply #39 on: April 05, 2019, 01:41:30 AM »

Model Number 106
Event Date 05/19/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A report was received indicating that a patient experienced a laryngeal spasm during generator replacement surgery. It was reported that the laryngeal spasm occurred after the new generator was implanted and minutes after two successful system diagnostic tests, heartbeat detection testing, and parameter programming were performed. The two system diagnostic tests indicated a measured lead impedance of 3,456 ohms and 2,758 ohms. Normal mode output current had been programmed on but was at a level lower than the previous device setting, 2. 75ma vs. 3. 0ma. The operating room anesthesia staff treated the condition for approximately 10 minutes and the spasm subsided. Although it was not known if the spasm was related to vns or not the normal mode output current was lowered to 1. 0ma as a precaution. The patient was observed in the recovery room and was doing fine with no complaints. It was reported that pre-operative diagnostics with the former device were normal with normal lead impedance observed (2,130 ohms) and eos = yes. It was reported that the prior device had not been working for the past 3-4 months due to a normal end of service battery condition. Follow up indicated that the device had been turned on and had delivered several stimulation cycles prior to the onset of the spasms. Based on this the surgeon believes it is difficult to determine what, if any, effect vns stimulation had on the spasm. No further spasms have been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5709236
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dennis100
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« Reply #40 on: April 13, 2019, 05:01:09 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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