BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1973178 · Received January 28, 2011

    Report

    Report Number
    2182208-2011-00031
    Event Type
    Death
    Date Received
    January 28, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE DEVICE "SHOCKED" THE PATIENT "MANY TIMES" WHILE THE PATIENT WAS "JUST SITTING". IT WAS ALSO REPORTED THAT THE PATIENT HAD A BROKEN "LEAD WIRE" BUT THE PATIENT WAS TOO WEAK TO HAVE AN OPERATION. IT WAS ALSO REPORTED THAT THE PATIENT GREW WORSE AND EVENTUALLY DIED OF HEART FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L