BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL 3

    MDR report key: 920890 · Received September 21, 2007

    Report

    Report Number
    6000032-2007-02891
    Event Type
    Death
    Date Received
    September 21, 2007
    Report Date
    March 16, 2005
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT REPRESENTS 1 UNREPORTED DEATH EVENT FOR THE MODEL 7425 FOR THE ABOVE TIME PERIOD (PRODUCT CODE LGW).

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THE PATIENT DEVELOPED AN INFECTION AT THE DEVICE SITE. THE PATIENT EXPIRED SOMETIME AFTER (DATE, TIME UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO., MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death EXPLANTED| EXPLANTED| EXTENSION MODEL 7498| LEAD MODEL 3888| EXPLANTED| EXTENSION MODEL 7498| LEAD MODEL 3888| EXPLANTED