BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4512490 · Received February 12, 2015

    Report

    Report Number
    3004209178-2015-02905
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V266792, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V230719, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-05, LOT# N195262, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS IN A REVISION CASE FOR NORMAL BATTERY DEPLETION. THE IMPEDANCES WERE CHECKED INTRA-OPERATIVELY AND WERE FINE. HOWEVER, AFTER THE PATIENT WAS CLOSED UP AND THE IMPEDANCES WERE CHECKED, THE LEFT SIDE #2 CONTACT WAS SHOWING HIGH. ALL COMBINATIONS CONTAINING CONTACT #2 WERE OVER 40,000 OHMS. THE ISSUE RESOLVED AFTER THEY WENT BACK IN AND DISCONNECTED AND RECONNECTED THE IMPLANTABLE NEUROSTIMULATOR (INS); THERE WAS FLUID INSIDE OF THE INS. NO LEAD FRACTURES WERE NOTED. THE PATIENT WAS DOING WELL, THE IMPEDANCES WERE NORMAL, AND SHE WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106492 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention