BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL 3

    MDR report key: 1080722 · Received July 23, 2008

    Report

    Report Number
    6000032-2008-04257
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DIED. THE CAUSE OF DEATH IS UNKNOWN. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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 Death IMPLANTED,| PROGRAMMER MODEL 7434A LOT# NGL012951P| EXPLANTED:| EXTENSION MODEL 7489 LOT# NHU012195V| IMPLANTED:| LEAD MODEL 3986A LOT# LB9492