InjuryNHW
PATCH
Received Oct 5, 2011 · Event occurred Jul 12, 2011
Report 2124215-2011-12613 · MDR key 2277722
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
56 YR
- Unspecified Infection
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS EPICARDIAL PATCH WAS EXPLANTED DUE TO PATIENT INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.
Additional Manufacturer Narrative
THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION.