BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3930202 · Received July 11, 2014

    Report

    Report Number
    3007566237-2014-01942
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387-40, LOT# J0519620V,IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE TIME WHEN AIRPORT SECURITY USED A HAND-HELD WAND OVER THE PATIENT¿S HEAD, ¿THE WIRES IN HER HEAD SIZZLED¿ AND SHE GOT A HEADACHE. THE PATIENT STATED THAT SHE LIED DOWN AND THEN WAS FINE. THE PATIENT NOTED THAT THIS OCCURRED ¿ABOUT SEVEN YEARS AGO.¿ THE PATIENT CONFIRMED THAT HER HEALTHCARE PROVIDER (HCP) WAS AWARE OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406428 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1