Pages: 1 [2]  All   Go Down
Print
Author Topic: Larynx  (Read 1734 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 57640


« 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
Logged
Pages: 1 [2]  All   Go Up
Print
Jump to: