12F SLS / LLD-EZ SPECTRANETICS CORP.

INDICATION FOR PROCEDURE: ENDOCARDITIS. PROCEDURE: THIS WAS A BILATERAL APPROACH PERFORMED IN THE OPERATING ROOM TO EXTRACT 4 PACEMAKER LEADS. MD ATTACHED THE LLD-EZ TO THE DISTAL END OF THE LEAD AND BEGAN LASING WITH THE 12F SLS. MD NOTICED THE LASER WAS TRACKING THE LEAD BUT THEN HEADED OUTSIDE OF TRICUSPID IMPLANT. PATIENT'S PACEMAKER LEAD WAS IMPLANTED IN 1984 AND THE TRICUSPID VALVE IN THE MID 1990'S. THE IMPLANTING MD CAPTURED THE LEAD BETWEEN THE TRICUSPID RING AND LATERAL HEART WALL. ALL LEFT-SIDED LEADS WERE REMOVED SUCCESSFULLY, BUT ULTIMATELY THE 12F SLS BECAME LODGED IN THE PATIENT'S BODY AND MD WAS UNABLE TO REMOVE THE SLS. IT WAS DECIDED TO LEAVE THE SLS IN THE PT AND WOULD BE SCHEDULED FOR AN OPEN CHEST PROCEDURE THE FOLLOWING MORNING. CT SURGEON OPENED THE PT'S CHEST THE NEXT DAY, SUCCESSFULLY REMOVED THE LEAD AND THE SLS. MD DETERMINED THE LEAD'S INSULATION WAS COMPROMISED AND BUNCHED UP INSIDE THE LASER MAKING IT IMPOSSIBLE TO REMOVE THE SLS.

ANALYSIS: THE DEVICES WERE DISPOSED OF DURING THE CODE AND WERE NOT RETURNED FOR ANALYSIS. THERE WERE NO ALLEGED DEFECTS OR NON-CONFORMANCES OF THE SPNC DEVICES. PATIENT OUTCOME: PATIENT RECOVERED AND WAS DISCHARGED WITH NO REPORTED DEFICITS. MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.