BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3123800 · Received May 22, 2013

    Report

    Report Number
    3007566237-2013-01700
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE ¿INTERFERENCE¿ MESSAGES ON THE CLINICIAN PROGRAMMER (8840) WHEN TRYING TO INTERROGATE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT TWO 8840¿S WERE TRIED. THE INS COULD BE INTERROGATED ¿FINE¿ WHEN IT WAS ON A TABLE IN A DIFFERENT AREA OF THE SURGERY ROOM. THERE WOULD BE INTERFERENCE WHEN THE INS WAS ON THE SURGICAL TABLE OR IN THE PATIENT. ¿SOME¿ EQUIPMENT, INCLUDING A ¿ROBOT¿ THAT WAS IN THE ROOM WAS TURNED OFF. THE PATIENT WAS ON THE TABLE AT THE TIME OF THE CALL. A FEW DAYS LATER, IT WAS STATED THAT BERCHTOLD LED LAMPS WERE CAUSING THE INTERFERENCE. ONCE THE LIGHTS WERE TURNED OFF, THE 8840 NO LONGER DISPLAYED THE ERROR MESSAGE. THERE WAS NO HARM TO THE PATIENT AT ANY TIME. THE PROCEDURE WAS SUCCESSFUL. TWO DIFFERENT INS¿S WERE USED IN TROUBLESHOOTING. THE INS ON THIS REPORT WAS NOT IMPLANTED IN THE PATIENT. REFER TO MANUFACTURER REPORT #3004209178-2013-08021 FOR THE REPORT WITH THE INS THAT WAS EVENTUALLY IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOT GETTING COMMUNICATION WITH THE INS. IT WAS NOTED THAT THE PATIENT ALSO HAD A PACEMAKER WITH A MAGNET ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225898 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1