BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3489206 · Received November 26, 2013

    Report

    Report Number
    3004209178-2013-21467
    Event Type
    Injury
    Date Received
    November 26, 2013
    Report Date
    November 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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 PRODUCTS: PRODUCT ID 3389S-40, LOT # V038036, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V050299, IMPLANTED: (B)(6)2007, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD THEIR DEEP BRAIN STIMULATION (DBS) SYSTEM EXPLANTED IN (B)(6) 2011 DUE TO LEAD EROSION THROUGH THE SCALP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614758 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention