Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Abscess (1690)
|
Event Date 05/17/2016 |
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.
|
|
Event Description
|
Device 2 of 2.Reference mfr.Report: 1627487-2016-02903.It was reported the patient's entire system was explanted on (b)(6) 2016 due to epidural abscess.In addition, a laminectomy was performed to clear the abscess.
|
|
Event Description
|
Device 2 of 2.Reference mfr.Report: 1627487-2016-02903.Follow-up identified the patient was admitted to in-patient care, and was doing 'fine'.
|
|
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
|
Device 2 of 2.Reference mfr.Report: 1627487-2016-02903.Follow-up identified the patient's epidural abscess has resolved.
|
|
Search Alerts/Recalls
|