BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAPY¿ DUAL-8¿ ABLATION CATHETER

    MDR report key: 6584370 · Received May 23, 2017

    Report

    Report Number
    2030404-2017-00018
    Event Type
    Death
    Date Received
    May 23, 2017
    Date of Event
    May 18, 2017
    Report Date
    May 23, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P040042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DISSECTION AND SUBSEQUENT PATIENT EXPIRATION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE PATIENT EXPIRED. AFTER A SUCCESSFUL PVC ABLATION, THE PATIENT BECAME HYPOTENSIVE, HAD ST ELEVATION, AND BIGEMINAL PVC'S. AN ANGIOGRAM REVEALED AN OCCLUDED LEFT MAIN CORONARY ARTERY AND A DISSECTED LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND WAS DEFIBRILLATED WITH NO RESOLUTION AND SUBSEQUENTLY EXPIRED. THE PATIENT HAD EXPIRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367094 THERAPY¿ DUAL-8¿ ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. IBI-83372 5713512

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death