BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2963983 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02720
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3389S-40, LOT# V087151, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GETTING HEADACHES FROM SUSPECTED ELECTROMAGNETIC INTERFERENCE (EMI) WITH THEIR DEVICE FROM THEIR HEADSET. IT WAS NOTED THAT THE PATIENT WAS GOING TO GET SMALLER HEADPHONES UNTIL THEY DID NOT GET HEADACHES. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66454 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1