BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3111046 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01605
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD "MULTIPLE" OPEN CIRCUITS "OUT OF NOWHERE." A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ANY FUTURE ADDITIONAL INFORMATION RECEIVED ON THIS EVENT WILL BE INCLUDED IN MANUFACTURING REPORT 3004209178-2013-04121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213308 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1