UNKNOWN
Received Oct 8, 2012 · Event occurred Jul 17, 2012
Report 2124215-2012-12242 · MDR key 2776196
Device
Product problems
- Connection Problem
- Material Integrity Problem
Patient
73 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE CHANGEOUT TO A NEW DEVICE WITH A CHRONIC EPICARDIAL LEAD, THE SETSCREW OF AN ATTEMPTED ADAPTER BECAME STUCK, PROHIBITING THE PHYSICIAN FROM PULLING THE TERMINAL PIN OF THE LEAD OUT OF THE ADAPTER. WHILE MANIPULATING THE LEAD, PHYSICAL DAMAGE WAS SUSTAINED, THEREFORE THE PHYSICIAN ELECTED TO CUT AND SURGICALLY ABANDON THE REMAINING PORTION OF THE LEAD, REMOVING THE ADAPTER WITH A PORTION OF THE LEAD STILL ATTACHED. NO INFORMATION COULD BE OBTAINED ON PRECISELY WHICH OF THE TWO KNOWN CHRONIC EPICARDIAL LEADS WERE INVOLVED IN THE EVENT. THE CHRONIC DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED ON THE OTHER SIDE OF THE PATIENT'S BODY WITH NO HEADER DAMAGE. THE REST OF THE CHRONIC LEADS WERE SURGICALLY ABANDONED ELECTIVELY AS THE IMPLANT SITE FOR THE NEW SYSTEM WAS ON THE LEFT SIDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
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.