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dennis100
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« Reply #300 on: July 26, 2019, 01:21:12 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 #301 on: August 10, 2019, 01:13:50 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's vns generator seemed to have migrated. The neurologist indicated that the generator migration may have caused the vns lead wires to press on the patient's thoracic duct and obstruct flow. The patient experienced swelling of the left arm, neck, leg, and hand. The neurologist indicated that the patient's left hand was more swollen than the right and was concerned the swelling may have been related to lymphedema. The patient's neurologist ordered the patient a compression garment. Clinic notes were received that mentioned x-rays were performed of the patient's neck and chest. The x-rays have not been received by the manufacturer for review to date. The notes indicated that the x-rays showed strain relief loop and that the leads were positioned appropriately. The x-ray notes reported the generator appeared to overlie the left chest, and per the x-ray assessment made by the surgeon the generator had not migrated into the armpit where it could endanger the lymphatic area. The patient was referred for generator replacement. No known relevant surgical intervention has occurred to date. 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=8775657
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dennis100
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« Reply #302 on: August 10, 2019, 01:14:27 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/30/2018
Event Type  Malfunction   
Event Description
It was reported by the patient's caregiver that the patient experienced heart rate increases correlating with the patient raising their arm. It was reported that the caregiver felt the patient's heart was pounding in their chest. The patient's vns settings were turned down by the neurologist; however, their seizures reportedly returned. 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=8780114
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dennis100
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« Reply #303 on: September 06, 2019, 10:45:48 PM »

Model Number 300-20
Device Problem Fracture
Event Date 07/26/2019
Event Type  Malfunction   
Event Description
Patient presented with high impedance. It was noted that earlier in the week the patient experienced a seizure and fell hitting his neck and chest on a counter. Impedance was noted to change as the patient moved his arm. The patient was referred for x-rays. The x-rays have not been received or reviewed to date. Patient was referred for full revision (replacement of the lead and generator).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8911570
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dennis100
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« Reply #304 on: September 06, 2019, 10:46:54 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/19/2019
Event Type  Injury   
Event Description
It was reported that the patient is referred for generator replacement due to battery depletion and potential total revision for complaints of pain shooting down his arm. It was reported that the patient was referred for replacement only but the physician did not do a diagnostic check before referring. No known surgery has 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=8888379
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