PATCH
Received Jan 10, 2011 · Event occurred Jun 26, 2008
Report 2124215-2010-24140 · MDR key 1953980
Device
Product problems
- Insufficient Device Problem Information
Patient
51 YR
- Unspecified Infection
- Foreign Body In Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THE DEVICE WAS EXPLANTED AND ALL FOUR LEADS, INCLUDING THE EPICARDIAL RATE/SENSE LEADS, WERE CUT AND ABANDONED. THE SURGEON DID NOT USE LEAD CAPS BUT MAY HAVE USED SUTURE TIES. THERE WAS NO INJURY TO THE PATIENT; IT WAS NOT KNOWN WHEN OR IF A NEW SYSTEM WAS TO BE IMPLANTED.
Additional Manufacturer Narrative
WHILE THE DEVICE WAS EXPLANTED IN (B)(6) 2008, THE DEVICE AND SEVERED LEADS WERE RETURNED TO BOSTON SCIENTIFIC IN (B)(6) 2010. A REVIEW OF MEDICAL RECORDS INDICATED THAT THE PATIENT EXPIRED IN (B)(6) 2008. NO CAUSE OF DEATH WAS REPORTED. NO NEW BOSTON SCIENTIFIC SYSTEM HAD BEEN IMPLANTED, AND IT WAS NOT KNOWN IF THE PATIENT HAD RECEIVED A COMPETITIVE SYSTEM. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.