Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Headache (1880); Discharge (2225); Discomfort (2330)
|
Event Type
Injury
|
Manufacturer Narrative
|
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 3 of 3.Reference mfr report #: 1627487-2017-06995, reference mfr report #: 1627487-2017-06996.It was reported that the patient experienced drainage at their trial site.In addition, the patient experienced burning, discomfort and headaches.The patient was instructed to go to the emergency room.
|
|
Event Description
|
Device 3 of 3, reference mfr report #: 1627487-2017-06995.Reference mfr report #: 1627487-2017-06996.Follow up revealed that there was no identified infection for this patient.Reportedly, the drainage from the paddle trial site was an expected drainage from the procedure.As a result, the patient underwent surgical intervention on (b)(6) 2017 wherein the leads were explanted.The issue was resolved post operatively.
|
|
Search Alerts/Recalls
|