BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3251642 · Received July 29, 2013

    Report

    Report Number
    3007566237-2013-02497
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013,PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_TUNNELINGTOOL, PRODUCT TYPE ACCESSORY. ANALYSIS OF THE EXTENSION FOUND THAT THE EXTENSION BODY WAS NOT STRAIGHT NEW OUT OF THE BOX. ANALYSIS OF THE TUNNELING TOOL FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STAGE II IMPLANT, THE DOCTOR NOTED THAT THE EXTENSION LOOKED KINKED. IT WAS NOTED THAT THE EXTENSION WAS CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND AN IMPEDANCE MEASUREMENT RESULTED IN HIGH IMPEDANCES. IT WAS NOTED THAT THE EXTENSION WAS CHANGED OUT AND EVERYTHING WAS RECONNECTED. AFTERWARD IMPEDANCE MEASUREMENTS WERE ALL IN RANGE. IT WAS NOTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353667 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR