BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5140830 · Received October 9, 2015

    Report

    Report Number
    3007566237-2015-02887
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Report Date
    September 15, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN REMOVED.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE (REP) REPORTED A MONTH LATER THAT THE BREAK WAS LIKELY IN THE EXTENSION. THE WIRE CONNECTING THE 3RD ELECTRODE WAS BROKEN IN THE EXTENSION AND TOUCHES THE WIRES FOR ELECTRODES 0 AND 2. THE CAUSE OF THE IMPEDANCE ISSUE WAS THE BROKEN EXTENSION.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE (REP) REPORTED AN IMPEDANCE ISSUE. IN AN ELECTRODE IMPEDANCE CHECK, THE FOLLOWING RESULTS WERE OBTAINED: CASE <(>&<)> #1 844 CASE <(>&<)> #2 514 CASE <(>&<)> #3 516 #0 <(>&<)> #1 644 #0 <(>&<)> #2 34 #0 <(>&<)> #3 35 #1 <(>&<)> #2 638 #1 <(>&<)> #3 638 #2 <(>&<)> #3 35 THE MEASUREMENTS WERE NOT CONSISTENT BETWEEN MONOPOLAR AND BIPOLAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT IF ANY INT ERVENTIONXX OR TROUBLESHOOTING WAS REQUIRED AND TO OBTAIN THE OUTCOME OF THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REP CLARIFIED THAT THERE WAS NO CONFIRMATION THAT THE EXTENSION WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670806 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1