16F SLS / LDD (UNKNOWN SIZE) SPECTRANETICS CORPORATION

MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.

INDICATION FOR PROCEDURE: INFECTION. PROCEDURE: THIS WAS A LEFT-SIDED PACEMAKER LEAD REMOVAL PROCEDURE CONDUCTED IN THE EP LAB. MD USED THE LLD TO ATTACH TO THE DISTAL TIPS OF THE 3 LEADS, BEGAN LASING WITH A 12 F SLS, THEN UP SIZED TO A 16F SLS. (RV & RA LEADS IMPLANTED IN (B) (6) 2001 & LV LEAD IMPLANTED IN 2007). THE LEADS WERE REMOVED IN THE FOLLOWING ORDER: LV, RV & RA. APPROXIMATELY 15 SECONDS AFTER THE RA LEAD WAS REMOVED THE PATIENT'S BP BEGAN DROPPING, THE CT SURGEON WAS PRESENT AT THE TIME AND A THORACOTOMY WAS DONE WITHIN 5 MINUTES. A HOLE IN THE CORONARY SINUS, IN ADDITION TO A CUT ALONG THE SEPTUM IN THE RV WERE FOUND AND SUCCESSFULLY REPAIRED. AN EPICARDIAL BI-V WAS PLACED IN THE PATIENT. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT REPORTED BY THE PHYSICIAN. PATIENT OUTCOME: THE PATIENT REPORTEDLY RECOVERED AND WAS DISCHARGED HOME SEVERAL DAYS POST-OPERATIVE.