BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1172972 · Received September 19, 2008

    Report

    Report Number
    3004209178-2008-05963
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION IS TURNING ON/OFF AND THAT MOVEMENT IS CAUSING STIMULATION CHANGES. THE REGISTERED NURSE TURNED THE PATIENT'S STIMULATION ON, BUT THE PATIENT MOVED A CERTAIN WAY, THERE WAS STIMULATION YET THE PATIENT PROGRAMER INDICATED THAT STIMULATION WAS OFF. NO FALLS OR TRAUMA OR RECENT MEDICAL PROCEDURE OCCURRED PRIOR TO THIS EVENT; HOWEVER, THE PATIENT IS RECEIVING PHYSICAL THERAPY. IT WAS REPORTED THAT THE PATIENT VISITED THE CLINIC BECAUSE OF DIFFICULTLY USING THE 'PATIENT PROGRAMMER' AND 'DEVICE'. THE LEAD IMPEDANCE MEASUREMENTS WERE NORMAL. THE PATIENT WAS IN THE CLINIC BUT WENT HOME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1