InjuryNHW
UNKNOWN
Received Jan 6, 2011 · Event occurred Nov 17, 2010
Report 2124215-2011-00255 · MDR key 1950629
Device
Product problems
- Insufficient Device Problem Information
Patient
65 YR
- Unspecified Infection
Narrative
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.
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
UPDATED INFORMATION: PLEASE NOTE THAT THIS LEAD IS NOT MANUFACTURED BY BOSTON SCIENTIFIC. THEREFORE, THE INITIAL REPORT WAS NOT REQUIRED TO BE SUBMITTED FROM BOSTON SCIENTIFIC.