InjuryNHW
ENPATH
Received Jan 7, 2011 · Event occurred Nov 29, 2010
Report 2124215-2010-23127 · MDR key 1951956
Device
Product problems
- Insufficient Device Problem Information
Patient
61 YR
- 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 WILL BE PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.