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dennis100
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« Reply #660 on: June 26, 2019, 07:27:53 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that this patient is being referred for generator replacement. The patient has had the vns implanted 10 years ago, and it is now off, and the neurologist wants to restart vns therapy for the patient. The patient later reported that they need an mri of their head, and has been having pain in his head. The patient reported that they would like the device out.
 
Event Description
Additional information was received from the neurologist¿s office stating that the patient's head pains were related to vns therapy per the patient, and the doctor was not sure of the relationship between the two as he did not interrogate the device. The patient's head pains were a contributing factor for surgery referral, but surgery is for patient comfort reasons. The doctor stated that the patient¿s device will be explanted, not replaced. 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=7240614
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dennis100
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« Reply #661 on: June 26, 2019, 07:28:41 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The doctor reported that the generator was nearing end of service and therefore a replacement was needed. The patient later stated that they would like to move forward with the replacement as they were reporting pain. The patient's husband had concerns regarding the magnet effectiveness and being referred to a surgeon in a timely manner as to avoid increased seizures and falls that the patient has experienced. The surgery has occurred for this patient's generator replacement. The device has not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The generator has been received by the manufacturer for product analysis. It was reported that the device was interrogated successfully prior to explant, and it was confirmed to be a prophylactic generator replacement. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7243747
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dennis100
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« Reply #662 on: June 27, 2019, 12:06:47 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's generator replacement referral. Per notes , the physician noted tenderness on the chest wall when the vns was interrogated. Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest. At the surgeon's consult appointment, the surgeon mentioned that the patient was ok. The surgeon has deferred repositioning the device. No known surgical interventions have occurred to date.
 
Event Description
Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation. Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness. The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device. The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders. The physician reported that the surgery was not planned for the pain. The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7318737
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dennis100
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« Reply #663 on: June 27, 2019, 12:07:44 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported the patient had her device removed because the patient felt that she had left chest and arm pain from the device. The explanted devices were discarded after explant and are not available for analysis. No additional or relevant information has been received to date.
 
Event Description
Additional information was received from the physician indicating that the explant for the pain was for patient comfort only and not to preclude a serious injury. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7245738
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dennis100
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« Reply #664 on: June 28, 2019, 10:57:33 PM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2002
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received indicating that a patient had experienced recurrent laryngeal nerve injury with vns. Per the notes, the patient also experienced a cough with mild pharyngeal pain or dysphagia. Programming history was reviewed for the patient's device, and diagnostics were within the normal limits on the date of implant and one month after implant surgery. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The physician reported that the patient experienced paresis in the recurrent laryngeal nerve due to initial vns implant surgery, which occurred nearly 14 years prior to the clinic notes. No medical intervention was taken for the nerve injury as it was a one time surgical injury. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7335848
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dennis100
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« Reply #665 on: June 28, 2019, 10:58:18 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was referred for vns replacement due to left neck pain, that was suspected as due to migration of the vns and a mass on the left side of the neck. The physician felt that the vns generator was slipping down and tension could be placed on the vns tie-downs and the patient's muscle, which could be causing the pain. A ct scan revealed no soft tissue mass nor fluid collection and everything appeared intact and normal. The impression from the ct results was that the palpable abnormality was likely related to the vns lead. The patient underwent vns repositioning surgery with no replacements instead. The surgeon repositioned the strain relief bend and loop for the lead and repositioned the generator. Diagnostics were reported as within normal limits. It was reported that the patient had weight loss surgery and lost a significant amount of weight and that the vns was pulling due to the weight loss. The patient settings were not adjusted. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to generator migration as it was bothering the patient. Follow up with the surgeon's office revealed that the surgical interventions were for the patient's comfort. Clinic notes were received by the manufacturer and indicated that the leads were "scarred in her neck and causing significant tension on the neck muscles. " it was noted that the generator pocket was very low on the patient's chest, more on top of the patient's breast, and created tension to the area when the patient was moving or standing, continuing to cause pain. It was noted that the generator pocket was not severe at first and the pocket was not revised. However, following the repositioning surgery, the neck pain resolved and the pain from the generator pocket was worse. The physician believed that this was due to tension due to the patient's breasts. A lidocaine patch was prescribed to the patient, but if the pain does not improve with the patch, repositioning surgery was to be performed. The patient underwent prophylactic vns generator replacement surgery. During attempts at product return, it was revealed that the explanted generator was discarded by the facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7534983
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dennis100
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« Reply #666 on: June 28, 2019, 10:59:15 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/30/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's vns was firing non-stop and causing intense chest and neck pain. The patient also felt sick and faint. Symptoms resolved after the output current was decreased from 2. 00 ma to 1. 50 ma. The patient's family reported that there was no trauma or manipulation to the vns. System diagnostics were within normal limits. The patient had previously been set to an output current of 2 ma for over 6 months. It was reported that the patient was admitted to the cardiac unit due to the chest pain; however, the full cardiac workup turned out to be negative. The patient's family indicated that they had been swiping the magnet more often which they believed could have led to the overstimulation. On the day of the event, he had an otherwise normal day until the evening when he suddenly "grasped his left chest" and stated that he was having sharp pain and discomfort. He also reported that he was having difficulty swallowing. This episode lasted "several minutes but seemed better" by the time they arrived at the hospital. While in the hospital, however, he again experienced "about 5 minutes" of grasping his chest, and experienced a sharp pain, throat pain, and difficulty swallowing. He continued to have repetitive episodes of chest pain, throat discomfort nausea, and feeling "sick" until the vns output current as decreased. The family felt that the patient's vns was firing longer than normal. No further relevant information has been received to date.
 
Event Description
It was reported that the only intervention taken when the patient was hospitalized was that the patient's settings were turned down. After that the patient was fine until two weeks later, where the symptoms, recurred and his device was disabled. She said that the patient was now fine. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7545787
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dennis100
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« Reply #667 on: July 01, 2019, 10:37:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient went into clinic to have his device turned on, but was experiencing pain in his neck as if the lead was pulling on his nerve and feels that the generator has slid down further on his chest than where it was originally implanted. The device was not turned on. Follow-up from the company representative who contacted the physician provided that the cause of the migration is unknown. The device was not turned on as physician wanted the patient to be relieved of his pain/discomfort before turning it on. The patient had put a strap around his chest to hold the generator in place and stop it from falling down and it had alleviated some discomfort. The device was later turned on and the patient tolerated the first settings well. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the surgeon provided that he has not evaluated the patient since the time of the reported migration, and that a non-absorbable suture was not used to secure the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7480005
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dennis100
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« Reply #668 on: July 01, 2019, 10:37:41 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2008
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Later information was received providing that the device is now causing pain and explant is planned. Follow-up to the provider indicated that the surgery had not been scheduled, but they may be planning it. They were not sure if it was to address a serious injury or for patient comfort since further discussion had not occurred with the patient. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7522417
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dennis100
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« Reply #669 on: July 01, 2019, 10:38:17 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient's husband that the vns was giving the patient a lot of problems. The patient's autostim output current was previously disabled due to discomfort, but the patient continued to have discomfort. The representative stated that x-rays and the vns was previously examined by the physician and no malfunction or failure was identified with the device. Clinic notes were later received that indicated that the patient's seizures were worse since the current vns generator was implanted. It was noted that the patient had recently been taken off of one of her aeds. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7244110
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dennis100
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« Reply #670 on: July 01, 2019, 10:39:12 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the vns was causing the patient pain and was protruding. It was stated that both the patient and patient's mother wanted the vns removed immediately. It was stated that the patient was not currently seeing a neurologist, but the pcp was to refer the patient to a surgeon that the patient's family knew. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7392007
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dennis100
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« Reply #671 on: July 02, 2019, 01:11:33 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient was experiencing soreness at her neck and was referred for exploratory surgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7344182
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dennis100
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« Reply #672 on: July 04, 2019, 01:11:10 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/19/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by a vns patient that he got a new device and whenever he moves his arm his device moves around. He stated that this has never occurred with any of his previous devices and that he is in discomfort because of the movement of the device. The patient stated there were no traumatic injuries that could have resulted in the generator becoming loose and moving around. It was later reported that the patient was experiencing discomfort with the device and the patient feels the generator is too big. The patient was referred for surgery to receive a smaller device. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Generator replacement surgery occurred (b)(6) 2018. The explanted device was reported to have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7472222
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dennis100
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« Reply #673 on: July 04, 2019, 01:11:54 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/23/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient has complained of constant stimulation and her device had to be disabled as a result. The physician did not run diagnostics on the device, but stated that the patient had a fall and hit her neck before her visit. As a result the patient will be referred for a full revision. The patient also reported a sore neck, ear, and throat due to the vns. The physician programmed the device off on (b)(6) 2018. Notes state she feels like she has a crick in neck and ct reported as normal. The patient had a full replacement on (b)(6) 2018 and the devices were discarded per the explanting facility's protocols. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Date of event, corrected data, initial mdr inadvertently reported incorrect event date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7699860
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dennis100
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« Reply #674 on: July 04, 2019, 01:12:43 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes from were received providing the patient feels there may be something wrong with the vns wires. The notes clarified that when she yawns she feels like something is stabbing her in the throat, at her left neck. She states it has been occurring over the last year. There are no problems during stimulation. She is not sure if she has moved the wire during a seizure. She was referred to surgery for repositioning or revision of the lead wire. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Generator replacement surgery occurred. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted devices were reported to have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686990
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dennis100
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« Reply #675 on: July 05, 2019, 10:47:11 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's mother reported that the patient is having difficulty with gagging and coughing. The patient's physician sent a surgery referral the day after this report was received. It was noted that after further observation, the patient¿s father noticed that the coughing and gagging were present even without stimulation occurring. The physician believed that the events may be side effects of the epidiolex that the patient was prescribed recently, however the physician did not deny relationship to vns therapy. Additionally, the physician decreased the signal frequency and pulse width parameters of the vns at the patient's appointment to mitigate these complaints. Further follow up with the physician confirmed that the patient also reports pain since vns was taped with the magnet. Additionally, the physician noted that the patient will be seen by neurosurgery for vns battery change to be scheduled. The physician noted that the patient is currently taking vimpat, lamotrigine, and trileptal medications which could be contributing to the reported events. It was noted that they will possibly be weaning the patient off of these medications. The physician refrained from confirming whether or not the reported pain, coughing, and dysphagia were factors to the surgery referral. 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=8744176
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dennis100
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« Reply #676 on: July 05, 2019, 10:47:50 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/11/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Patient was referred for replacement of the generator due to low battery and possible revision of the lead due to pain in the jaw that occurred with stimulation. The patient underwent generator replacement. The explanted generator was stated to have been discarded. The explanted product has not been received by product analysis to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8678440
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dennis100
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« Reply #677 on: July 11, 2019, 01:59:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/17/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported migration is not related to the functionality or delivery of therapy of the device.
 
Event Description
The physician sent in clinic notes for the patient's surgery referral. Within the clinic notes, it is mentioned that the patient's vns generator has migrated underneath their left axilla and is causing discomfort with movement. It was noted that the patient has been referred to surgeon for repositioning of the generator and proximal lead wire into a more medial position in an effort to prevent further irritation from its current position. No known surgical intervention has occurred to date. Note that once surgery takes place, 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 other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8686348
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dennis100
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« Reply #678 on: July 11, 2019, 02:00:42 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient was experiencing pain and was not tolerating magnet swipes. Clinic notes were provided and mentioned that the patient gets a left-sided pulling of her mouth and body twitching with every magnet swipe, along with headaches. This is said to have been going on for a few months. Clinic notes also mentioned that patient experienced an event where she was shaking, and her left lip was "drawn downward;" she was having difficulty using her left side upper extremities and her arm was painful. This was reported to have occurred after the magnet was used during diagnostics. The physician disabled the vns due to patient¿s episodes after magnet swipes. The patient stated that although the device was turned off, the "pulling" sensation on the left side of her face persisted, and she had tightness on the left side of her upper extremities. The patient was reportedly taken by ambulance to the hospital and admitted for one night. It was also mentioned in the notes that the patient is too afraid to use the magnet to abort seizures because of the mouth "pulling" sensation. The physician informed that the a surgery referral has been placed for patient comfort reasons. Additionally, the physician believes that the reported side effects may be related to the patient's pseudo seizures. The reason for the patient¿s hospitalization was not provided. 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=8676229
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« Reply #679 on: July 11, 2019, 02:01:21 AM »

Model Number 304-20
Device Problem High impedance
Event Date 05/30/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient's seizure frequency began to worsen after having a fall. The patient was seen by the physician and found that there was high lead impedance. The patient has been implanted about two years and has been having good benefit from vns. X-rays and radiology note was sent in for review. The radiology note indicated the patient was also having pain in the neck along with high impedance after seizure related fall. Based on the x-rays received, the cause of the high impedance cannot be determined. Note that a microfracture or discontinuity in the portions of the lead that were not visible cannot be ruled out. The device history record's of the lead was reviewed. The lead passed final quality and functional specifications prior to release. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8728246
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« Reply #680 on: July 11, 2019, 02:02:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's husband reported that the patient had a psychotic break down and has been inpatient for about the last month. The husband believes vns settings are too high which is causing his wife's problems. He noted that his wife has reacted horribly to magnet swipes, stating that she was having pain in the neck and coughing. The patient's group home later called and reported behavioral changes and frequent urination for this patient. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8667403
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« Reply #681 on: July 11, 2019, 02:02:39 AM »

Model Number 302-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/23/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy. (b)(4).
 
Event Description
It was reported that the patient¿s generator was protruding from her skin, and she was referred for surgery. Clinic notes received indicate that the wire was extruding through the skin and has been having pain. It was stated that there was an opening in the skin anterior to superior aspect of left axilla with lead protruding. Her husband stated that he believes a fall in the tub caused the extrusion. A fax was received from the physician. There was no obvious cause to the fall, and the protrusion started about a month prior. The surgery was for patient comfort and for possible infection. The patient¿s generator and lead were replaced. 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=8680066
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« Reply #682 on: July 11, 2019, 02:03:20 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/13/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the patient caregiver that the patient had two seizures above baseline since having vns replacement. The provider does not believe that the seizures are associated with vns but can be attributed to the surgery pain and pulse width tolerance. Pulse width was lowered and the patient will be seen again to assess seizures and tolerability. Information was received that the location of the pain from the surgery is unknown. The cause of the patient not tolerating the pulse width was attributed to patient physiology. Provider is speculating because the patient is non-verbal that since the pulse width was programmed high, lowering the pulse width would lower pain and raise tolerance. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8716063
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« Reply #683 on: July 11, 2019, 02:04:07 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/28/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was being referred for explant due to unknown reason. During follow-up for the reason, it was stated that the patient was not able to tolerate titration and was the reason for explant. Information was received indicating that the patient has a low pain tolerance. Vns diagnostics were stated to be normal and autostim is off. The patient has not been able to up titrate due to pain/tolerance. The patient is the one who requested that vns be removed and the physician's office is not able to do anything about this. Clinic notes were received indicating the patient is scheduled for explant due to vns pain and a burning sensation. The physician attempted to titrate the patient's settings up but was unable to tolerate and is no longer willing to have the settings increased. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8716055
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dennis100
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« Reply #684 on: July 11, 2019, 02:04:53 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported in (b)(6) 2018 that the patient was being referred for explant due to pain and swelling. In (b)(6) 2018, it was reported that the patient first reported chest pain about a year prior. It was mentioned that the patient wanted to have their device explanted because they felt that the device was not helping, however the device was disabled earlier that year as the physician stated there had been reduction in the frequency of seizures. In (b)(6) 2018, the surgeon believed that it was highly unlikely that the vns device was causing the pain and swelling, and the neurologist believed that the pain was due to possible fibromyalgia, unrelated to the vns therapy system. The surgeon went on to state that he informed the patient that explanting the generator would not guarantee pain reduction or pain alleviation. However, due to the patient being adamant about explanation, the patient was referred for surgery. Device diagnostics information was not received at this time, however it was mentioned that the patient was at a low setting. The patient later reported, in (b)(6) 2019, that the vns caused jerking, falling, strokes, flushing of the breasts (turned red per patient), and pain throughout the body. The patient also mentioned that the vns caused both their breasts to hurt and turn red, and that both breasts needed to be taken out. Multiple attempts have been made to the physician for an assessment of these allegations, and there relationship to the vns and surgery referral, however no response has been received to date. 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=8724571
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dennis100
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« Reply #685 on: July 16, 2019, 11:19:04 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient's vns had migrated from the chest to the underarm and was causing pain. The patient expressed her desire to have the device removed. It was later reported that the patient was referred for generator replacement surgery. Device diagnostics were reported to be normal. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7878253
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dennis100
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« Reply #686 on: July 16, 2019, 11:19:47 PM »

Model Number 300-20
Device Problem Mechanical Problem
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A patient underwent a full revision surgery for patient comfort due to a chronic neck pain. The neurologist was unsure if the pain was related to the device or not. The explanted devices were shipped back for analysis. Analysis was completed for the generator, indicating no apparent device malfunctions. The lead assembly was returned in four portions; the portion of the lead assembly including the electrodes and tie downs was not returned. Setscrew marks were observed on both connector pins, indicating good electrical connection existed at one point. Abraded openings were found on both the outer and inner silicone tubing in one of the return portions of the lead. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Other than the abraded tubing openings, no additional obvious anomalies were noted. It was concluded that the abraded openings were likely due to normal wear. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7912423
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