InjuryNHW
ENPATH
Received Apr 14, 2011 · Event occurred Mar 9, 2011
Report 2124215-2011-05152 · MDR key 2055407
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
72 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE PHYSICIAN ELECTED NOT TO EXPLANT THIS PRODUCT DURING THE REVISION PROCEDURE, AND IT WILL REMAIN IMPLANTED. 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 EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.