BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAPY¿COOL PATH¿DUO ABLATION CATHETER

    MDR report key: 5519295 · Received March 23, 2016

    Report

    Report Number
    2030404-2016-00009
    Event Type
    Death
    Date Received
    March 23, 2016
    Date of Event
    November 16, 2015
    Report Date
    March 14, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4) THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDITIS MAY HAVE BEEN PROCEDURE RELATED.

    Description of Event or Problem · 1

    FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT DEVELOPED PERICARDITIS AND SEPTICEMIA. THE ABLATION PROCEDURE WAS COMPLETED WITH NO ISSUES NOTED BUT THE PATIENT DEVELOPED PERICARDITIS POST-PROCEDURE DUE TO ABLATION ON THE POSTERIOR WALL OF THE LEFT ATRIUM. THE PATIENT THEN DEVELOPED SEPTICEMIA, WHICH WAS TREATED WITH ANTIBIOTICS AND LOCAL ANESTHETIC; HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE DURING THE ABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175341 THERAPY¿COOL PATH¿DUO ABLATION CATHETER CATHETER, ELECTRODE RECORDING OAD ST. JUDE MEDICAL, INC. IBI-83565 5052416

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death