BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM II

    MDR report key: 1222166 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07250
    Event Type
    Death
    Date Received
    November 6, 2008
    Date of Event
    July 4, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AND AN INJURY WAS MADE AS TO WHETHER THE PATIENT PROGRAMMER COULD BE DONATED. CAUSE OF DEATH IS UNKNOWN AND IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LEAD: MODEL 3889| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037