16F SLS / LLD (UNKNOWN SIZE) SPECTRANETICS CORPORATION

INDICATION FOR PROCEDURE: INFECTION. PROCEDURE: THIS WAS A LEFT-SIDED PACEMAKER LEAD REMOVAL PROCEDURE CONDUCTED IN THE OPERATING ROOM. MD USED THE LLD TO ATTACH TO THE DISTAL TIPS OF THE 4 LEADS, LASING WITH A 16F SLS. (2 LEADS IMPLANTED IN 2001 & 2 IMPLANTED IN 1981). THE 2 NEWER LEADS OF THE 4 WERE EXTRACTED WITH NO DIFFICULTY. WHILE TRYING TO REMOVE THE 2 OLDER LEADS THE MD NOTED A SLIGHT DROP IN THE PATIENT'S BP. FLUOROSCOPY WAS CHECKED AND IT WAS NOTED THE PATIENT'S LEFT LUNG WAS NOT EXPANDING. THE CT SURGEON WAS CALLED AND PLACED A CHEST TUBE IN THE PATIENT'S LUNG TO SUCCESSFULLY RE-EXPAND. THE PATIENT'S VITALS STABILIZED. MD MADE THE DECISION TO CAP AND ABANDON THE 2 OLDER LEADS. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT REPORTED BY THE PHYSICIAN. PATIENT OUTCOMES: THE PATIENT REPORTEDLY RECOVERED AND WAS DISCHARGED HOME SEVERAL DAYS POST-OPERATIVE.

MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.