BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3121937 · Received May 21, 2013

    Report

    Report Number
    3007566237-2013-01688
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S NEUROSTIMULATOR HAD NORMALLY DEPLETED THREE YEARS AGO. THE PATIENT WAS REFERRED TO THE HCP ONLY FOR EXPLANTING. THE INS WAS NOT REPLACED AS THE PATIENT¿S DISEASE HAD IMPROVED AND THERE WAS NO NEED FOR IT ANYMORE. IT WAS NOTED THAT THERAPY HAD BEEN TURNED OFF FOR THE PAST THREE YEARS. SEE ALSO MFR. REP. # 3007566237-2013-01689.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATORS HAVE ¿STOPPED FUNCTIONING.¿ IT WAS NOTED THE PATIENT WANTED BOTH IMPLANTS REMOVED. THE HEALTH CARE PROFESSIONAL WAS PLANNING TO LEAVE THE LEADS AND CONNECTORS IN PLACE AND ONLY REMOVE THE STIMULATORS UNLESS IT WAS NOT ADVISED. IF NOT ADVISED THE HEALTH CARE PROFESSIONAL WOULD SEND THE PATIENT SOMEWHERE ELSE TO HAVE THE SYSTEM REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224809 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1