InjuryNHW
ENPATH
Received Oct 21, 2010 · Event occurred Sep 29, 2010
Report 2124215-2010-19405 · MDR key 1878722
Device
Product problems
- Insufficient Device Problem Information
Patient
49 YR
- Unspecified Infection
- Foreign Body In Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. HOWEVER, THIS LEAD WAS SURGICALLY ABANDONED AND REMAINS INSIDE THE PATIENT'S BODY. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Additional Manufacturer Narrative
DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE PRODUCT IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.