Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Therapeutic Effects, Unexpected (2099)
|
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 2 of 2.Reference mfr.Report: 1627487-2018-05545.It was reported the patient was receiving unintended abdominal stimulation due to lead location.As such, surgical intervention was undertaken on (b)(6) 2018 during which the leads were explanted and replaced.
|
|
Event Description
|
Device 2 of 2 : reference mfr.Report: 1627487-2018-05545.Follow-up identified the patient has effective stimulation following the procedure.
|
|
Search Alerts/Recalls
|