UNKNOWN
Received Jan 13, 2012 · Event occurred Dec 14, 2011
Report 2124215-2012-00567 · MDR key 2415545
Device
Product problems
- Fracture
- Use of Device Problem
Patient
50 YR
- No Consequences Or Impact To Patient
Narrative
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 THE RING LEAD WAS PLUGGED INTO THE BIFURCATED PORTION OF THE PACEMAKER AND THAT THIS LEAD HAD A COMPLETE FRACTURE OF THE CONDUCTOR. THIS LEAD HAD A PREVIOUS BREAK NEAR THE TERMINAL, BUT HAD BEEN REPAIRED AND HAD A NON-BOSTON ADAPTOR IN PLACE TO PUT IT INTO THE DEVICE. THE ADAPTOR WAS CUT OFF AND THE LEAD WAS SURGICALLY ABANDONED. HOWEVER, UPON THE REMOVAL OF THE PACEMAKER, THE HEADER SEPARATED FROM THE CAN WITHOUT EFFORT WHEN A SLIGHT TORQUE WAS APPLIED.