BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3253822 · Received July 30, 2013

    Report

    Report Number
    3004209178-2013-12473
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V530092, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# L75840, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿PERSISTENT EXCRUCIATING SHOCKS¿ WHICH LASTED UP TO 30 SECONDS. IT WAS NOTED THAT THE SHOCKS WERE ¿SO STRONG¿ THEY WOULD IMMOBILIZE THE PATIENT. THE SHOCKING SEEMED RANDOM AND NOT RELATED TO MOVEMENT. THE SYMPTOMS BEGAN AROUND (B)(6) 2011. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356256 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR