Model Number 3788 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
Burning Sensation (2146)
|
Event Type
Injury
|
Manufacturer Narrative
|
This device model is associated with a field correction.The event date is unknown.The results/method and conclusion codes along with the investigation results will be provided in the final report.Concomitant medical products and therapy dates: model: 3721, scs charging system, therapy date: unknown.
|
|
Event Description
|
Device 1 of 2.Reference mfr.Report#: 1627487-2019-12011.This report is related to a (b)(6) patient.It was reported the patient had been experiencing pocket heating while recharging their ipg.As a result, the patient's ipg was explanted and replaced.Surgical intervention addressed the patient's issue.
|
|
Event Description
|
Device 1 of 2: reference mfr.Report#: 1627487-2019-12011.
|
|
Event Description
|
Device 1 of 2 reference mfr.Report#: 1627487-2019-12011.
|
|
Search Alerts/Recalls
|