InjuryNHW
ENPATH
Received Jan 5, 2011 · Event occurred Nov 9, 2010
Report 2124215-2010-22304 · MDR key 1949574
Device
Product problems
- Insufficient Device Problem Information
Patient
65 YR
- Unspecified Infection
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
FURTHER INVESTIGATION INDICATES THIS LEAD IS NOT MANUFACTURED BY BOSTON SCIENTIFIC. ENPATH IS THE ORIGINAL MANUFACTURER AND IS RESPONSIBLE FOR REPORTING REQUIREMENTS.
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 SURGICALLY ABANDONED DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.