BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3790076 · Received May 5, 2014

    Report

    Report Number
    3007566237-2014-01231
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN OUT OF REGULATION (OOR) TWICE. IT WAS NOTED THAT THE PATIENT HAD TWO PRIMARY CELL DEVICES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES HAD NOT CHANGED MUCH WHEN THEY WERE CHECKED IN VARIOUS NECK AND STRAINED POSITIONS. X-RAYS WERE ORDERED FOR THE HEAD, NECK AND CHEST AND HAD NOT FOUND ANY OBVIOUS BREAKS. THE PATIENT WAS RECEIVING THERAPY AND THE HEALTHCARE PROFESSIONAL HAD INCREASED THE VOLTAGE WITHOUT ANYTHING ABNORMAL OCCURRING WITH THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268703 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1