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dennis100
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« Reply #60 on: June 23, 2019, 04:26:17 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing some tightness around the generator after an increase in device settings on (b)(6) 2017. Diagnostics were within normal limits. She also called the physician¿s office on (b)(6) 2017 complaining of pain. Clinic notes were later received on (b)(6) 2017 for surgery referral. The physician noted the ¿vns is malfunctioning¿. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided in follow-up report#1 that the lead had also been replaced.
 
Event Description
Lead replacement occurred with the generator replacement surgery. The lead was also reported to have been discarded.
 
Event Description
Additional notes were received providing the vns is still malfunctioning. Generator replacement surgery occurred. The explanted device was reported to have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7166890
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dennis100
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« Reply #61 on: June 28, 2019, 11:23:05 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 #62 on: July 01, 2019, 10:20:32 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for full vns replacement surgery as the vns lead had become uncomfortable and the generator was near end of service, or neos. The patient's vns generator was implanted on her upper back due to previous non-vns related chest surgeries. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Follow up with the physician's office revealed that the discomfort possibly began within the last year. It was stated that there was mild discomfort due to the vns lead looping on the left lateral neck. It was reported that it was visibly protruding and that it was not so much pain as it was tightness or a lead pulling sensation. It was stated that the surgical intervention was for the patient's comfort.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7488181
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dennis100
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« Reply #63 on: July 05, 2019, 11:08:03 PM »

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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dennis100
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« Reply #64 on: July 05, 2019, 11:08:43 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/07/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's neurologist reported that the patient's seizures had worsened and the patient experienced chest tightness / pain. It was reported that the vns stimulation was the cause of the adverse events and that there were no known external factors contributing to the patient's reported adverse events. It was reported that the patient was unable to tolerate the vns stimulation which led to the device output currents being disabled. 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=8695977
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dennis100
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« Reply #65 on: July 11, 2019, 02:15:10 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient has neck swelling and that the patient had a recent placement of the vns on the left. The patient also has sensation of throat tightening. The patient was assessed left vocal cord paralysis was identified and abnormal asymmetric thickening of the left aryepiglottic fold which lies cephalad of the paralyzed left vocal cord. There was also a 13 mm solid nodule at the inferior pole of the left thyroid lobe. The patient¿s device has not been programmed on yet. Information was received from the patient that she can barely talk or breathe. The likely cause of the paralysis was from the surgical procedure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7678836
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dennis100
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« Reply #66 on: July 16, 2019, 11:28:23 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a large dog had jumped on the patient and the patient believed the vns had migrated. It was reported that the vns started firing and not stopping, which made the patient's throat feel tight. It was stated that the patient's o2 stats were ok. The patient's grandmother taped the magnet over the vns to magnet disable the device. The patient was admitted to the hospital and seen by neurology. The vns was disabled and the patient was sent home. It was stated that the patient was scheduled for surgery to fix or replace the vns. It was later reported that the patient also felt vibration and experienced hoarseness. Diagnostics were within normal limits. It was stated that the vns was disabled as the patient felt better when the vns was off. No relevant surgery 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=7911408
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dennis100
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« Reply #67 on: July 23, 2019, 01:07:44 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported to a company representative that a vns patient was experiencing painful stimulation 5-10 times per day. Impedance values were reported to be good. The patient reports tension of the lead in the neck, but no pain or impedance changes with lateral rotation. The patient was referred for x-rays and referred to neurosurgery. It was later reported that generator replacement surgery occurred. The explant facility does not return devices to the manufacturer. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7867487
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dennis100
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« Reply #68 on: July 23, 2019, 01:08:25 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/30/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing side effects such as voice loss/ alterations, tightening of the neck muscles, the patient¿s jaw moving more, and headaches. The patient wished to have the device removed and was referred for surgery. No known surgical intervention has 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=8104539
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dennis100
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« Reply #69 on: July 27, 2019, 12:43:42 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/08/2018
Event Type  Injury   
Event Description
Patient reported experiencing tightening of the lead wire with simulation which causes ear pain. The patient was referred for generator replacement due to low battery and lead replacement due to the pain. 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=8302844
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dennis100
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« Reply #70 on: August 10, 2019, 02:14:20 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 01/10/2019
Event Type  Malfunction   
Event Description
It was reported by the physician that the patient was seen due to breakthrough seizures. Upon vns interrogation, the patient's impedance was low. The patient also reportedly had swiped her magnet 3 days after the seizure and 30 minutes later, she felt local discomfort over the device and had some accompanying chest tightness. Due to persistent discomfort she went to local er the next day. The physician reported that the patient was now feeling better but still had some mild local discomfort. It was determined through data review that low impedance had been observed on date of the generator implant in (b)(6) via system diagnostics on the new generator. Pre-operatively, diagnostics on the generator that would be explanted were okay. Follow-up with the attending representative found that during this patient's implanting surgery, there was a concern of contamination so the first generator in process of being used was discarded and a new generator was used. The generator that was opened but not used had no evidence of low impedance in the programming data. Per the attending representative, there was no report of the surgeon damaging the lead. Review of the internal data of the generator indicated that low impedance had been observed intermittently since implant in (b)(6). No other anomalies identified. Programming history review of the patient's previous generator showed no evidence of low impedance. The device history records for the implanted generator were reviewed. The generator passed final functional and quality specifications prior to release. 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=8790088
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