Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bruise/Contusion (1754); Complaint, Ill-Defined (2331)
|
Event Type
Injury
|
Event Description
|
It was reported the patient had skin necrosis two years after having the implantable neurostimulator (ins) implanted.The patient had pain at the device pocket and around the ins.The skin around the ins was badly affected and was black and blue.There was a point of pressure as if there was a piece of skin that stuck out on the surface of the ins.A revision was scheduled for next week.The patient status at the time of this report was alive with injury.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Additional information received reported the patient had an infection.The implantable neurostimulator and extensions had been explanted.The patient was doing well, but they were in pain.
|
|
Manufacturer Narrative
|
Concomitant products: product id: neu_unknown_lead, product type lead.(b)(4).
|
|
Event Description
|
The health care provider (hcp) reported via the company representative (rep) three months later that the skin necrosis was at the pocket site.The patient experienced an ins allergic reaction.The leads remained in the brain after the ins and extensions were explanted.An allergy test was performed and now the dermatologist found out that the patient was allergic to polyurethane a80.Skin erosion was noted.The patient needs to be implanted with a deep brain stimulation (dbs) system again, therefore, the neurosurgeon was asking for a solution.The issue was not resolved at the time of this report.
|
|
Event Description
|
The rep reported a month later that the leads will not be explanted.A new ins will be implanted when the patient feels comfortable with that idea.This will be discussed with the patient in three weeks.
|
|
Search Alerts/Recalls
|