Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abscess (1690); Pain (1994)
|
Event Date 06/08/2015 |
Event Type
Injury
|
Event Description
|
Device 1 of 2.Reference mfr.Report:1627487-2015-03261.It was reported, the patient's scs trial leads were pulled mid trial due to lower back pain as a result, of an abscess.Follow-up information identified the low back pain has resolved and the abscess was evacuated.
|
|
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.
|
|
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.(b)(4).
|
|
Event Description
|
Device 1 of 2.Reference mfr.Report:1627487-2015-03261.
|
|
Search Alerts/Recalls
|