BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3363188 · Received September 23, 2013

    Report

    Report Number
    3004209178-2013-16795
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Report Date
    August 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37603, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THERE WERE LOW OUT OF RANGE IMPEDANCE MEASUREMENTS. ELECTRODES 0 AND 3 SHOWED 34OHMS. THE PATIENT WAS PROGRAMMED AT 2-3+ AND THE PATIENT WAS DOING WELL. IT WAS NOTED THAT PATIENT WAS COMPLICATED IN THE PAST. HE WAS IN A WHEEL CHAIR BUT NOW HE WAS WALKING WITH A CANE. THERE HAS BEEN NO FALLS OR TRAUMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478905 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1