Model Number 3286 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Neurological Deficit/Dysfunction (1982)
|
Event Date 05/30/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
|
|
Event Description
|
Device 3 of 3: reference mfr.Report: 1627487-2018-05550, reference mfr.Report: 1627487-2018-05551.It was reported the patient experienced a neurological deficiency on her right side.As such, the patient's entire system was explanted on (b)(6) 2018.
|
|
Event Description
|
Device 3 of 3: reference mfr.Report: 1627487-2018-05550, reference mfr.Report: 1627487-2018-05551.Follow-up identified the patient had experienced pain in her flank/abdomen, weakness and instability post-implant.The physician believed the symptoms were attributed to the system.The symptoms have resolved following explant.
|
|
Search Alerts/Recalls
|