Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/05/2018 |
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 2 of 5.Reference mfr.Report: 3006705815-2018-02406; reference mfr.Report: 3006705815-2018-02407; reference mfr.Report: 1627487-2018-09163; reference mfr.Report: 1627487-2018-09199.It was reported the patient's lead revision was abandoned due to anesthesia and airway issues on (b)(6) 2018 (please see mfr.Report #: 3006705815-2018-02434).As a result, the patient¿s scs system was explanted.
|
|
Event Description
|
Device 2 of 5: reference mfr.Report: 3006705815-2018-02406, reference mfr.Report: 3006705815-2018-02407, reference mfr.Report: 1627487-2018-09163, reference mfr.Report: 1627487-2018-09199.Follow-up information provided the patient has recovered.
|
|
Search Alerts/Recalls
|