BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BURR HOLE RING

    MDR report key: 4173571 · Received October 15, 2014

    Report

    Report Number
    3007566237-2014-02992
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-29, LOT# N259454, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SKIN EROSION AROUND THE LEFT BURR HOLE. THE SKIN INCISION WHERE THE BURR HOLE WAS LOCATED WAS REVISED AND NO PRODUCT WAS REPLACED. THE IMPEDANCES WERE TAKEN AND ALL WITHIN RANGE. THE PATIENT¿S SYMPTOMS WERE WELL-CONTROLLED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652863 UNKNOWN BURR HOLE RING STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_BURRHOLERING

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention