BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1950373 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-10465
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION. THE PT PROGRAMMER DISPLAY SHOWED "CALL YOUR DOCTOR" ICON. THE DEVICE WAS ALSO IN A "POWER ON RESET" (POR) CONDITION. ADD'L INFO WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V508214| PROGRAMMER: MODEL PROGRAMMER, LOT # UNK