InjuryNHW
PATCH
Received Jul 11, 2011 · Event occurred Apr 13, 2011
Report 2124215-2011-06692 · MDR key 2156250
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
86 YR
- Unspecified Infection
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO A PATIENT POCKET INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Additional Manufacturer Narrative
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.