InjuryNHW
PATCH
Received Oct 7, 2013 · Event occurred Aug 1, 2013
Report 2124215-2013-13528 · MDR key 3392060
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
55 YR
- Endocarditis
- Unspecified Infection
Narrative
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.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.