BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4011991 · Received August 15, 2014

    Report

    Report Number
    3007566237-2014-02284
    Event Type
    Injury
    Date Received
    August 15, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT BEING TREATED FOR PARKINSON¿S DISEASE HAD THEIR RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED THE DAY PRIOR TO REPORT. THE INS WAS REPLACED FOLLOWING A LOW IMPEDANCE MEASUREMENT OF 9 OHMS ON THE BIPOLAR ELECTRODE PAIR 0 AND 3. IMPEDANCE TESTING ON ALL OTHER UNIPOLAR ELECTRODES AND BIPOLAR ELECTRODE PAIRS WAS NOTED TO HAVE FOUND ¿NORMAL VALUES.¿ THE EVENT REPORTEDLY PRESENTED A ¿MODERATE¿ HEALTH HAZARD TO THE PATIENT AND IT WAS NOTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR RECOVERY. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490334 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R