BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 2083635 · Received May 10, 2011

    Report

    Report Number
    6000094-2011-00669
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    January 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death