BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2834203 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10328
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889BLUE_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SEVERAL LEAD INSERTION ATTEMPTS WITH HIGH IMPEDANCES. THE REPORTER STATED THAT NO MOTOR RESPONSES WERE VISIBLE WITH STIMULATION UP TO 6 VOLTS WHEN PROGRAMMING ELECTRODES 2 AND 3. IT WAS NOTED THAT THE ELECTRODES WERE CONNECTED TO THE INTERNAL NEUROSTIMULATOR DURING TESTING, ELECTRODE READINGS WERE AT 4,000 OHMS, AND CYCLING WAS USED. THE INTERNAL NEUROSTIMULATOR WAS REMOVED AND THE ELECTRODES WERE RETESTED WITH A CABLE AND SCREENER. IT WAS NOTED THAT HIGHER VOLTAGES WERE NEEDED TO OBTAIN MOTOR RESPONSES THAN DURING THE LEAD PLACEMENT, WHERE 2-3 VOLTS WERE NEEDED TO OBTAIN MOTOR RESPONSE. OTHER ELECTRODE COMBINATIONS WERE TESTED THROUGHOUT THE LEAD WITH THE SCREENER AND ALL REGISTERED HIGHER VALUES OR "NOTHING" WHEN COMPARED TO THE INITIAL LEAD PLACEMENT. TWO DAYS LATER IT WAS REPORTED THAT NO CAUSE OF THE ISSUE HAD BEEN DETERMINED AND A NEW LEAD WAS USED DURING THE SURGERY. THE REPORTER STATED THAT THE PATIENT WAS RECEIVING GOOD RESULTS AND THE OUTCOME WAS SUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1