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Author Topic: Voice/Speech  (Read 129123 times)
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dennis100
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« Reply #660 on: January 04, 2019, 11:15:31 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. 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=8127177
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dennis100
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« Reply #661 on: January 04, 2019, 11:16:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the vns was causing issues for the patient. It was later reported that the patient's vns was shut off due to hoarseness, dizziness, and blacking out. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190069
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dennis100
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« Reply #662 on: January 04, 2019, 11:17:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Event Description
It was reported by an emergency room physician that the patient's generator was continuously stimulating for several hours. It was reported that the physician attempted to disable the device using the vns magnet as well as a pacemaker magnet, but that the device continued to stimulate and the patient was admitted to the hospital. A company representative reported that the patient experienced neck pain and hoarseness that persisted despite the device being programmed off. The patient's device diagnostics were within normal limits. It was reported that the patient had recently had a seizure and had fallen and either hit her head or neck. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8178588
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dennis100
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« Reply #663 on: January 05, 2019, 03:42:56 AM »

Model Number 1000
Event Date 10/18/2018
Event Type  Death   
Event Description
Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8155362
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dennis100
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« Reply #664 on: January 07, 2019, 03:20:33 AM »

Model Number 302-20
Event Date 01/09/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 were received which indicate that the patient returned to the clinic for a consultation. Per the notes, since his last visit, the patient states he is experiencing increased seizures. The patient states that he no longer feels the vagal nerve stimulator when it activates. The patient denies any injuries to the head or neck. The patient stated that a few weeks ago, he developed a left frontal headache and hoarseness. The patient is tolerating his medications well. Per the notes, the vns device was interrogated and diagnostics were performed. Diagnostics demonstrated high impedances and inability to output current. X-rays will be ordered to assess for lead fracture. Notes dated (b)(6) 2013 indicate the patient has been having about one seizure every three weeks. The patient reports this is due to the fact that he has been spacing out his medications due to the risk of running short. Notes dated (b)(6) 2013 indicate the patient was having difficulty affording his medication and cut back on his does. Subsequently, he had four seizures. The patient's vns generator was replaced on (b)(6) 2014. Attempts were made for additional information; however, they were unsuccessful. The explanted device will not be returned to the manufacturer, as it has been discarded. No additional information has been received in regards to these events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3608421
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dennis100
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« Reply #665 on: January 07, 2019, 03:21:31 AM »

Model Number 304-20
Event Date 01/05/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device had high lead impedance. Follow up with the physician found that the high lead impedance was observed on (b)(6) 2014. The vns device was programmed off to 0ma following the observation of the high lead impedance. The patient stated that she came into contact with a large magnet over christmas ((b)(6) 2013) and felt strange afterward. The physician will not provide any additional information. Ap and lateral chest and neck x-rays dated (b)(6) 2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. It cannot be assessed if the lead pin is fully inserted as the lead pin is not visible past the connector block. Feed thru wires appear intact. Lead wires appear intact at the connector pins. The lead coils behind the generator before routing upward to the left neck. The portion of lead behind the generator cannot be assessed. The electrodes appear aligned. A strain relief bend is present and appears to be per labeling. No strain relief loop is present. Two tie-downs are visible; however, the tie-downs are not placed per labeling as the first tie-down is not positioned laterally to the anchor tether. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. There are several slivers in the neck area near the electrode; however, these appear to be behind the lead body and not interacting with the lead. No other information has been provided.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The patient reported via facebook comment in 2017 that the vns caused voice alteration and at a higher dose, she felt discomfort in her left neck, left lower tooth and left side of forehead for which her neurologist adjusted dose and time interval in response. She indicated that depending on the slant of her head, she felt that the vns was more intense. In addition, the patient reported brain freezes when she had to take her medications with cold water. She believed it was possible that the vns was going off at that time and causing it. The patient reported during follow-up with company representatives that her vns wasn't changed after high impedance a couple of months after having a cough. She said that she ended up getting pneumonia. The treating neurologist's nurse indicated that while the patient's pneumonia and the high impedance was noted in the patient's clinic notes, she didn't see anything connecting the pneumonia to the high impedance. The programming database and internal data of the patient's generator was reviewed. Per the data, it was found that the patient's generator was re-enabled. Also, it was found that the patient's impedance appeared to be fluctuating from high to normal until (b)(6) 2014, after which there was no further incidents of high impedance. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3622212
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dennis100
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« Reply #666 on: January 10, 2019, 02:07:16 AM »

Model Number 302-20
Event Date 01/15/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's device was programmed back on as there was no difference in the spasmodic dysphonia with or without vns stimulation. No further relevant information has been received to date.
 
Event Description
It was reported by the ent physician that the vns patient was seen in his office on (b)(6) 2014. Clinic notes were from the office visit were received indicating that diagnostic flexible fiberoptic laryngoscopy revealed left vocal cord paralysis possibly from a displaced lead. The notes also indicated that the patient recently went to the er where ct showed left vocal cord paralysis. The patient was having severe pain in her left throat and pain when swallowing. The ent physician suggests that the pain may possibly be due to a displaced lead, and advised the patient to have her generator programmed off. Additional information was received from the patient stating that she had been experiencing severe pain and had taped her magnet over her generator to disable stimulation. Whenever the magnet shifted out of place, the patient reported that she experiences a shock and the pain worsens. The patient was seen by a surgeon to discuss vns replacement. The surgeon believes that the patient does not have vocal cord paralysis but has irregular spasmodic movement of her left vocal cord which followed a severe upper respiratory tract infection. The surgeon stated that the patient¿s symptoms seem to worsen with vns stimulation. The surgeon does not believe that the reported event requires surgery, but suggested lowering the patient¿s settings. While the surgeon believes that the reported event is not due to vns, the neurologist believes there is a relationship with the reported event and vns. As suggested by the surgeon, the neurologist lowered the patient¿s settings. Review of the available programming and diagnostic history for the device did not reveal any anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3658670
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dennis100
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« Reply #667 on: January 11, 2019, 02:48:50 AM »

Model Number 102
Event Date 06/06/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that this vns patient was referred for revision due to pain. Clinic notes dated (b)(6) 2014 stated that no changes were made to patient¿s medications as she was tolerating her medications well. The patient¿s device settings were increased during the visit. The patient presented with increased chest pain during an office visit on (b)(6) 2014. A chest ct was reported by the physician to be unremarkable. The patient¿s device settings were lowered during the office visit. The patient complained of persistent pain in her left chest and her left upper extremities during an office visit on (b)(6) 2014. The patient¿s device was programmed off, and it was noted that the pain was also occurring without stimulation. The patient reported that she was still feeling electricity-like pain in her arm and palm. The patient had previously reported that she began feeling pain in the vns area of the chest along with a headache and slight fever after entering a building and passing through a metal detector in (b)(6) 2013. It was confirmed that the events are occurring continuously as well as with stimulation. She also stated that she has been experiencing voice alteration with stimulation which she did not experience previously. Additionally, she was seizure-free for a while and had one seizure. At that time, diagnostics were normal and the battery was reported to be fine as well. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717363
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dennis100
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« Reply #668 on: January 12, 2019, 03:53:55 AM »

Model Number 303-20
Event Date 11/18/2013
Event Type  Injury   
Event Description
On (b)(4) 2014, it was reported that this patient was evaluated by an ent on (b)(6) 2014 for continuous hoarseness. The visit report stated that the patient had "weakness of the left vocal cord" that was mild and would likely resolve. No interventions were taken. The patient had previously reported coughing and constant voice alteration following implant surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734895
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dennis100
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« Reply #669 on: January 14, 2019, 04:28:27 AM »

Model Number 302-20
Event Date 04/13/2014
Event Type  Injury   
Event Description
It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370
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dennis100
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« Reply #670 on: January 15, 2019, 03:07:51 AM »

Model Number 304-20
Event Date 04/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed ct scans of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Ct scans reviewed by manufacturer, unable to assess lead continuity or lead pin insertion. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient's device was disabled on (b)(6) 2014. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. Due to the poor quality of the images, lead pin insertion and the filter feed-through wires cannot be assessed. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc - 7). The patient¿s device was not programmed off following the high impedance observation. Ct scans were provided to the manufacturer for review but were unable to determine the integrity of the lead and whether the lead pin was fully inserted into the generator header. The last known good system diagnostic results were from the date of implant. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. Further follow-up revealed that the implant surgeon hit the patient¿s jugular as he tunneled from chest to neck. The patient was seen 15 days after implant surgery and presented with severe voice hoarseness. The patient¿s device was programmed on during an office visit on (b)(6) 2013. During the office visit on (b)(6) 2014, the patient¿s device settings were increased. A diagnostic test was subsequently performed and a warning message appeared indicating high impedance and limited output current. The neurologist misinterpreted the diagnostic results and increased the patient¿s device settings. A second diagnostic test was performed which revealed the high lead impedance. It was reported that the patient was doing well. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3823884
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dennis100
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« Reply #671 on: January 15, 2019, 03:08:33 AM »

Model Number 300-20
Event Date 04/19/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value = 10,000 ohms). The neurologist suspected fibrosis was causing high impedance as the patient was experiencing voice hoarseness with normal mode stimulation every five minutes. The patient was referred for generator and lead replacement surgery but no known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3810277
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dennis100
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« Reply #672 on: January 16, 2019, 02:35:23 AM »

Model Number 302-20
Event Date 04/19/2014
Event Type  Malfunction   
Event Description
The patient's generator product information was provided by the implanting hospital on (b)(6)2014.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The explanting facility does not return devices; therefore no analysis will be performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The neurologist suspected fibrosis was causing high impedance as the patient was experiencing voice hoarseness with normal mode stimulation every five minutes. The patient was referred for generator and lead replacement surgery but no known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808627
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