BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 1981946 · Received February 8, 2011

    Report

    Report Number
    2182208-2011-00046
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    December 13, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT DIED 11 DAYS POST IMPLANT OF THE LEFT VENTRICULAR EPI-CARDIAL PATCH AND APPROXIMATELY TWO AND HALF WEEKS POST IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR, RIGHT VENTRICULAR EPI-CARDIAL LEAD, AND LEFT VENTRICULAR SUB-CUTANEOUS COIL. THROUGH FOLLOW UP THE PHYSICIAN REPORTED THAT IT WAS NOT AN ARRHYTHMIC DEATH. CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death