BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM III AT

    MDR report key: 1913396 · Received December 3, 2010

    Report

    Report Number
    2647346-2010-00773
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    November 21, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980050/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 WIFE THAT THE PATIENT DIED AND THE WIFE "THOUGHT THE DEVICE COULD HAVE BEEN THE CAUSE." SHE REPORTED THE CAUSE OF DEATH WAS HEART ATTACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM III AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7276 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death