BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2930265 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00985
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO ADJUST THE STIMULATION. "CALL YOUR DOCTOR" ICON WAS DISPLAYED ON THE SCREEN OF THE PATIENT PROGRAMMER. A POWER ON RESET (POR) CONDITION WAS REPORTED. IT WAS MENTIONED THAT THE PATIENT SAW A CALL YOUR DOCTOR/POR SCREEN AFTER THE PROCEDURE ON THE DAY OF THE REPORT AND AFTER TURNING ON THE PROGRAMMER. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN TURNED ON YET AND IT WAS UNKNOWN IF INS HAD BEEN PROGRAMMED AFTER THE PROCEDURE.. IT WAS ALSO REPORTED THAT REPROGRAMMING TOOK PLACE FOUR DAYS LATER WHICH "WENT FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35305 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1