Model Number 3688 |
Device Problem
Low Battery (2584)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 06/20/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).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 has not been able to feel any stimulation for the past couple of months.The patient stated her patient programmer displays the "low ipg battery" warning.Surgical intervention is planned for a later date to address the issue.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Follow-up identified the patient's scs ipg was explanted and replaced.The patient's scs stimulation therapy has reportedly been restored and the reported issue has been resolved.
|
|
Search Alerts/Recalls
|