InjuryNHW
ENPATH
Received Jan 5, 2011 · Event occurred Nov 9, 2010
Report 2124215-2010-22305 · MDR key 1949530
Device
Product problems
- Insufficient Device Problem Information
- Appropriate Device Problem Term/Code Not Available
Patient
65 YR
- Unspecified Infection
- No Information
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.
Additional Manufacturer Narrative
FURTHER INVESTIGATION INDICATES THIS LEAD IS NOT MANUFACTURED BY BOSTON SCIENTIFIC AS THIS LEAD IS MANUFACTURED BY ENPATH. ENPATH REQUIRES REPORTING RESPONSIBILITIES FOR THIS LEAD.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS SURGICALLY ABANDONED DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.