Model Number 104 |
Device Problem
No Display/Image (1183)
|
Patient Problems
Unspecified Infection (1930); Tissue Breakdown (2681)
|
Event Date 12/01/2016 |
Event Type
Injury
|
Event Description
|
It was initially reported that there was concern about the patient's generator site.Additional information was received that the generator was extruding from the site and was visible.This was stated to be caused by an ongoing infection at the generator site that initially occurred during the patient's vns replacement surgery.There was an abscess that was draining at the site and topical antibiotics were prescribed.The patient was referred for surgery to address the issue and possibly explant the vns device.A review of device history records showed that both the lead and generator were sterilized prior to distribution.No surgical intervention is known to have occurred to date.No additional relevant information has been received to date.
|
|
Manufacturer Narrative
|
Device evaluation is not necessary because the reported infection has been determined as not related to vns therapy but rather the vns surgery.Explanted date: corrected information - in the initial report the explant date should have been included as the device had been explanted at the time of the report.
|
|
Event Description
|
The patient's generator was explanted due to the infection.A new generator was reimplanted at a later date.The medical professional for the patient mentioned that there was a possibility of the patient picking at the implant site causing the infection however this was just a possibility with no confirmation.
|
|
Event Description
|
Additional information was received the patient had an infection and the current implanted vns device was extruding.These events for the patient are reported in med watch # 1644487-2019-00517.The infection and extrusion events were attributed to the previous infection and extrusion reported in this med watch.
|
|
Search Alerts/Recalls
|