BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5154219 · Received October 15, 2015

    Report

    Report Number
    3007566237-2015-02973
    Event Type
    Injury
    Date Received
    October 15, 2015
    Report Date
    September 21, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE PATIENT HAD DEEP BRAIN STIMULATION (DBS) TWICE. THE REPORTER STATED THE FIRST ONE WAS A GREAT SUCCESS AND THE SECOND ONE WAS "BOTCHED." THE HEALTH CARE PROVIDER (HCP) HAD IMPLANTED THE LEAD TOO DEEP IN THE PATIENT'S BRAIN CAUSING IRREVERSIBLE BRAIN DAMAGE. THE PATIENT'S LIFE WAS CHANGED FOREVER. THE REPORTER STATED THEY NEED HELP FOR THE PATIENT AND EVERY DOOR THEY TRY TO OPEN GOT SHUT IN THEIR FACE. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682196 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other