Model Number 3788 |
Device Problems
Nonstandard Device (1420); Communication or Transmission Problem (2896)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 02/28/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).This ipg serial number was included in a field advisory.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).
|
|
Event Description
|
It was reported the patient's ipg would not communicate with external devices.Per the manufacturer's device database, surgical intervention was undertaken to explant and replace the ipg.
|
|
Event Description
|
Follow-up identified the patient last used and charged the ipg in (b)(6) 2016.
|
|
Event Description
|
Follow-up identified effective stimulation was restored following the procedure.
|
|
Search Alerts/Recalls
|