BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3842820 · Received June 2, 2014

    Report

    Report Number
    3007566237-2014-01496
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD ERODED THROUGH THE SKIN. THE INS WAS REPORTEDLY (B)(6). THE EXTENSIONS HAD TO BE CUT TO REMOVE THE INS. TWO DAYS LATER, IT WAS REPORTED THAT THERE HAD BEEN NO RE-IMPLANT YET AS THE LEAD REQUIRED AN EXTENSION TYPE THAT HAD BEEN DISCONTINUED FOR A FEW YEARS ALREADY. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. THE LEAD AND PART OF THE EXTENSION WERE STILL INSIDE THE PATIENT. FURTHER INFORMATION WAS NEEDED BEFORE A TOTAL REVISION COULD OCCUR. APPROXIMATELY A WEEK LATER, IT WAS REPORTED THAT THERE WAS NO CURRENT EXTENSION TYPE THAT WOULD FIT WITH THE ¿(B)(6) LEAD¿. A COMPLETE REVISION WAS "LIKELY GOING TO BE REQUIRED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320837 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention