InjuryNHW
UNKNOWN
Received Apr 9, 2012 · Event occurred Feb 24, 2012
Report 2124215-2012-03911 · MDR key 2522450
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
57 YR
- Unspecified Infection
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS EPICARDIAL LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.
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.