BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3844999 · Received June 3, 2014

    Report

    Report Number
    3007566237-2014-01505
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU _UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED INTRA-OPERATIVE THE DOCTOR WAS UNABLE TO CONNECT A PRIMARY CELL IMPLANTABLE NEUROSTIMULATOR (INS) TO A SINGLE PRONG INS. IT WAS STATED A POCKET ADAPTOR WOULD BE NEEDED. IT WAS NOTED THE PATIENT WAS OPEN ON THE TABLE WITH NO CONVERSION. IT WAS STATED THE INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323643 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1