Description of Event or Problem · 1
ON (B)(6) 2013 PATIENT HAD LEAD EXTRACTION FOR POSSIBLE FRACTURED LEAD AT (B)(6) HOSPITAL, (B)(6) US. PATIENT ADVISED CARDIOLOGY ELECTROPHYSICIST MD THAT HE KNEW THE LEAD HAD BEEN ANCHORED WITH SCREW TYPE HOOK 10 YEARS PRIOR AT INSTALLATION. MD INDICATED HE WOULD USE "NEW LASER" - SPECTRANETICS LASER SYSTEM WAS USED TO EXTRACT. POST-OP PATIENT WAS ADVISED THERE WERE NO COMPLICATIONS BUT THERE HAD BEEN A TEAR AND IT HAD BEEN CAUTERIZED. CHRONIC LEAD WAS NOT REPLACED AND CHRONIC LEAD WAS RETURNED TO MEDTRONICS (RV LEAD 5076/52 SER. NO. (B)(4)) PATIENT SUBSEQUENTLY HAD WORSENING CONDITION BUT MD KEPT INSISTING NOTHING SHOULD BE WRONG. PATIENT SOUGHT SECOND OPINION ELSEWHERE AND TEE ON (B)(6) 2013 INDICATED FLAIL TRICUSPID VALVE LEAFLET, FREE WALL LEAFLET TORN IN THE INFEROLATERAL AREA WITH SEVERE TRICUSPID REGURGITATION; PERI-AORTIC HEMATOMA NOTED ANTERIOR AND BILATERALLY ALONG DISTAL THORACIC AORTA/NO INTIMAL TEAR. PATIENT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2013 AT (B)(6) HOSPITAL IN (B)(6) FOR REPAIRS. SURGICAL REPORT INDICATES WIDE TEAR OF TRICUSPID VALVE LEAFLETS, CORRESPONDING TO THE SEPTAL LEAFLETS AND POSTERIOR LEAFLETS FROM ANNULUS FOR ABOUT 1.5 CM IN LENGTH. AT LEAST 2 RUPTURED PRIMARY CHORDS CORRESPONDING TO SAME AREA. PERICARDIAL PATCH APPLIED TO TORN LEAFLET; TEAR BETWEEN SEPTAL AND POSTERIOR LEAFLETS REATTACHED BACK TO EACH OTHER AT A POINT OF GOOD PRIMARY CHORDAL SUPPORT CAUSING REDUCED SIZE OF TRICUSPID VALVE. INJECTION DID SHOW GOOD COMPETENCY.