InjuryNHW
ENPATH
Received Apr 15, 2011 · Event occurred Mar 31, 2011
Report 2124215-2011-05926 · MDR key 2059939
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
77 YR
- Pocket Erosion
Narrative
Additional Manufacturer Narrative
THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.
Additional Manufacturer Narrative
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Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A SUBCUTANEOUS EROSION OF THIS POCKET WAS OBSERVED. THE REVISION PROCEDURE WAS PERFORMED AND THE POCKET WAS DRAINED AND CULTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.