BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL 3

    MDR report key: 769920 · Received October 13, 2006

    Report

    Report Number
    6000032-2006-01698
    Event Type
    Death
    Date Received
    October 13, 2006
    Date of Event
    September 1, 2006
    Report Date
    September 21, 2006
    Manufacturer
    MED REL, INC.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A PATIENT'S DEATH. DESPITE SEVERAL ATTEMPTS BY THE MANUFACTURER, NO INFORMATION ON CAUSE OF DEATH HAS BEEN OBTAINED. A DEATH CERTIFICATE WILL BE REQUESTED. REF MFR REPORT # 6000030-2006-01700.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW GZB MED REL, INC. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death IMPLANTED| EXTENSION MODEL 7495-5,1 LOT # XR0040194N