12F SLS SPECTRANETICS CORP.

INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS A LEFT SIDED, DUAL CHAMBER PACING SYSTEM LEAD REMOVAL PERFORMED IN THE EP LAB. APPROXIMATE 5-6 YEAR OLD LEADS (1 ACTIVE, 1 PASSIVE) TO BE REMOVED. MD BEGAN WITH COOK DILATOR SHEATH TO REMOVE THE VENTRICULAR LEAD. UPON REMOVAL OF THE LEAD, THE MD NOTED TISSUE ON THE DISTAL END OF THE LEAD. THE PATIENT'S BLOOD PRESSURE BEGAN SLOWLY DROPPING AND THE CT SURGEON WAS PAGED. THE 12F SLS HAD BEEN PREPPED, MD LASED OVER ATRIAL LEAD SUCCESSFULLY REMOVING IT. A PERICARDIOCENTESIS WAS PERFORMED, CT SURGEON ARRIVED AND BEGAN WITH A XIPHOID WINDOW TO REPAIR THE RV PERFORATION. ULTIMATELY A FULL STERNOTOMY WAS PERFORMED TO REPAIR THE INJURY. ANALYSIS: THERE WERE NO DEVICES RETURNED FROM THIS CASE. MD INDICATED NO MALFUNCTIONS OF DEVICES USED. PATIENT OUTCOME: PATIENT RECOVERED AND WAS DISCHARGED WITH NO REPORTED DEFICITS.

MANUFACTURER DATES FOR ALL DEVICES: (B) (4) UNKNOWN.