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dennis100
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« Reply #690 on: July 20, 2019, 10:32:37 PM »

Model Number 106
Device Problem High impedance
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that high impedance was detected approximately two months post-implant of the patient's vns. The patient reported that she had had a recent fall and that afterward had the sensation of electrical stimulation and pain radiating up into her neck. The patient reported a "violent head movement" during the fall, the vns site was also slightly swollen consistent with contusion. The patient's generator was disabled due to the high impedance and she was referred for surgery. Per the manufacturer's device history records, the generator and lead passed final quality and functional specifications prior to release. On (b)(6) 2018, exploratory surgery was performed. Per the surgeon, the visible lead in the chest pocket looked normal with no evidence of a lead fracture. He reinserted the lead pin and afterwards, the high impedance resolved. The lead pin was reinserted a second time into the generator and impedance was again normal. This indicates that incomplete pin insertion was the cause of the patient's high impedance. Incomplete pin insertion is where the setscrew has not been tightened enough to secure the lead pin in the generator; it can be resolved by reinserting and correctly tightening the pin. However, the surgeon elected to replace the patient's generator. The explanted generator was received and underwent analysis. The generator was monitored for more than 24 hours in a simulated body temperature environment. The generator provided the intended output current for the entirety of the monitoring period. The generator performed according to functional specifications with no anomalies identified. Review of the generator's internal data showed evidence of intermittent high impedance. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7785605
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dennis100
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« Reply #691 on: July 20, 2019, 10:33:48 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a prophylactic replacement surgery, and that the patient¿s heart rate would drop to the 30-40 bpm range approximately every minute. Due to the drop in heart rate, the neurosurgeon decided to lower the output current. The patient's neurologist reported that the low heart rate occurs when the vns is on. System diagnostics were received from the date the device was implanted and were within normal limits. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Initial mdr inadvertently omitted information that was known prior to submission.
 
Event Description
The patient also experienced vomiting which was reported to be caused by pain and the low heart rate when the vns is on. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8092613
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dennis100
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« Reply #692 on: July 23, 2019, 01:17:27 AM »

Model Number 3000
Device Problems Computer Software Problem; Energy Output Problem
Event Date 05/23/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient reported that at her last appointment her generator was reset to "factory settings". She was able to be programmed back to her original setting but was in the end programmed to lower settings due to discomfort at her original settings. She had not noticed anything unusual in her stimulation pattern prior to this report. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8185614
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dennis100
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« Reply #693 on: July 23, 2019, 01:18:38 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190458
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dennis100
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« Reply #694 on: July 26, 2019, 01:31:47 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the device extrusion is not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient reported discomfort following vns implant. The patient reports that they could see the vns generator and lead coming out of their skin. They also stated that they can feel the device sliding and moving close to their armpit. No known surgical intervention has occurred to date for the generator or lead. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8277830
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dennis100
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« Reply #695 on: July 26, 2019, 01:32:32 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/02/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Patient complaint of tenderness and possible infection at generator incision site. The generator was explanted several years ago due to infection. Generator explant due to infection in 2008 is captured in mfr. Report #1644487-2009-00087. Further information was received from the physician's office confirming that a culture was not performed to confirm the presence of an infection. Design history records were reviewed for the lead. The lead passed all specifications and was confirmed to be sterilized prior to distribution. No known surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
Further information was received that the patient experienced drainage and an opening in the lateral chest wound. It was noted that the patient felt pain when stretching his arm and was referred to a neurosurgeon. The surgeon saw the patient and noted that he was uncertain whether or not an infection was present. There was no underlying edema and no obvious opening of drainage. This resulted in the surgeon deciding to remove the lead/all remaining parts of the vns. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8290389
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dennis100
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« Reply #696 on: July 26, 2019, 01:33:50 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the patient was admitted to the hospital for right sided weakness and chest pain and the patient reported that he had had chronic problems with the vns. The patient also reported focal seizures, the last of which was in (b)(6) 2018. Upon follow-up with the patient, it was reported that the patient was experiencing shortness of breath, chest pain, and pain in his throat which had reportedly been occurring on and off for the past few weeks. The on-call physician did not seem to think these symptoms were related to the vns. System diagnostics and normal mode diagnostics were ok. The patient's vns output frequency was lowered from 30 to 20 hz at the direction of the neurologist, who thought this would alleviate some of the symptoms. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8153856
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dennis100
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« Reply #697 on: July 27, 2019, 12:51:48 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/19/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.
 
Event Description
The patient later reported that when her neck it flexed forward, or her hands are on her chest, the device seems to stimulate. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The patient later reported that she is having an increased sensitivity with clonic jerks, poor large muscle control upon movement, blurred vision, slurred speech, headaches, and a longer recovery time after seizures. She stated she was also having increased light sensitivity. The patient thinks some of the symptoms may be related to medications, but it is not confirmed. She did note that she had a 5 day veeg. She was taken off of 2 of her medications and had a decrease in symptoms of ataxia and stated the majority of her symptoms were medication induced. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
The patient later reported she has had a lot of pinching around the axilla of the left breast incision, and displacement of the device upon moving around in bed. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician stating the patient's symptoms were related to medications. Additionally, the physician did not believe the patient's pinching sensation was related to vns and no interventions have been taken due to the reported pinching sensation.
 
Event Description
Further information was received that the patient was experiencing an exacerbation of symptoms with vns including sleeping disturbances, ambulatory difficulties, and dysphagia. It was also reported that these symptoms started after her device was programmed back on in june 2017, indicating it had been previously turned off. No other relevant information was received from the patient's physician.
 
Event Description
Further information was received that the patient believed she had new issues with vns. Specifically, she complained of having "charlie horses in throat" on the left side vocal cord when she yawned or opened her mouth to sing. She also reported that she has experienced pain in the chest that extends down to her left arm. This pain was reportedly not constant (it "comes and goes"). The patient also reported having continued issues that were previously reported such as dysphagia, erratic stimulation, speech impediment, and ambulatory issues. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649
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dennis100
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« Reply #698 on: July 30, 2019, 10:45:16 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2019
Event Type  Injury   
Event Description
It was reported from a nurse at the hospital that the patient was admitted due to the generator causing the patient pain especially when she lies down. The patient reported that this started occurring recently and got continually worse. The patient stated the device was not working but based this on the pain she was experiencing and no other adverse events or seizure activity. She reported a burning sensation around the generator site as well that occurred every 15 minutes or so. The nurse stated the pain wasn't associated with stimulation but she also couldn't be sure it was constant either. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8418353
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dennis100
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« Reply #699 on: July 30, 2019, 10:46:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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dennis100
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« Reply #700 on: July 30, 2019, 10:48:52 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/02/2019
Event Type  Injury   
Event Description
It was reported from a patient that she was feeling pain after settings were increased for her seizures. The patient later saw her neurologist who turned the settings down, however the patient was still feeling the pain. It was clarified that the patient was not feeling pain with stimulation, although she only began feeling the pain after settings were previously increased. An update was received stating that the constant pain was occurring behind the patient's electrode site on the neck. It was noted that the patient had been taken to the er due to increased seizures and intolerable pain in her neck. She stated that her vns was "not working" and that she wanted it removed. The patient was still experiencing pain after decreasing settings. Follow up with the physician's office confirmed that when the patient was last seen, the output current was decreased due to pain and swelling in the neck and throat after previously increasing settings. It was unknown what the cause of the pain, swelling, and increased seizures were at this time. No known surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8320621
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dennis100
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« Reply #701 on: August 10, 2019, 02:15:59 AM »

Model Number 103
Device Problem Appropriate Term/Code Not Available
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Patient reported on social media that she started to have problems described to be bee sting like feeling shocks all over the left side of the body and in the patient¿s stomach. Patient reported pain around the brain stem. The patient reported that the pain was getting worse in the neck wire and was unbearable. The patient noted that she was seen by a physician a month ago and it was found that the device was malfunctioning therefore it was disabled. It was noted that the pain stopped after device disablement. The patient noted that she was referred for device explant. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8807124
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dennis100
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« Reply #702 on: August 10, 2019, 02:16:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reported that they experienced pain and swelling in their neck that started about two months prior to the report. The patient described the pain as a pulling sensation and knotting in the neck. Per the patient, the neurologist mentioned that the stimulation is irritating the patient's muscles, but referred the patient to the surgeon for a consult. Further follow up with the neurologist's office confirmed that the cause of the neck pain and swelling was due to the device migrating to the right side. The patient has been referred to the surgeon for further assessment. Per the physician, the referral for surgery is for both patient comfort reasons and to preclude serious injury. It was mentioned that this is all the information that the physician's office has at this point in time. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8756469
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dennis100
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« Reply #703 on: August 10, 2019, 02:17:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient¿s generator had migrated inferiorly and was causing the patient pain. The patient underwent repositioning surgery for patient comfort. The surgeon had opened the old incision, pulled the generator up, and added another suture through the suture hole. By adding another suture, it is assumed that the patient's original suture was still present. The patient was later explanted to due lack of efficacy, discomfort, and migration. The patient was suspected of picking at the incision site. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8822885
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dennis100
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« Reply #704 on: August 10, 2019, 02:18:09 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/03/2019
Event Type  Injury   
Event Description
It was reported by the patient that their vns lead was protruding and that they experienced neck irritation/sensitivity. It was indicated that the patient felt discomfort when he tugged on his neck or moved their neck too far back. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8824745
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dennis100
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« Reply #705 on: August 10, 2019, 02:18:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2019
Event Type  Injury   
Event Description
It was reported by the neurologist that the patient experienced a big seizure and has had pain. It was reported that the pain was not occurring with stimulation but occurred when the patient pushed on the vns or when the patient laid on their stomach. The patient was previously in a car accident and the pain may have been related to the placement of the seat belt. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8766021
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