BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3250489 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12365
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    February 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V591641, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V590200, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOUR MONTHS AGO THE PATIENT EXPERIENCED EYELID APRAXIA AND ¿THE EYELIDS KEPT CLOSING AND THEY CAN¿T OPEN.¿ THE MOST RECENT PROGRAMMING CHANGE WAS SIX MONTHS AGO AND CONTACTS EIGHT AND NINE WERE USED FOR PROGRAMMING. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL AT 3V FOR THESE CONTACTS. THE IMPEDANCE MEASUREMENTS DID NOT SUGGEST A SHORT CIRCUIT, BUT AN OPEN CIRCUIT WAS REPORTED ON THE CASE AND 11 AROUND 19 ,000, WHICH WAS NOT A CONTACT BEING USED FOR THERAPY. IT WAS ALSO REPORTED THE DEVICE WAS TURNED OFF AND ON AND APRAXIA WAS NOT PRESENT FOR EITHER. THE HEALTHCARE PROVIDER (HCP) DID NOT FEEL IT IS RELATED TO DEEP BRAIN STIMULATION. LEVODOPA MEDICATIONS HAD BEEN INCREASED AND THE HCP SUGGESTED REDUCING. IT WAS ALSO NOTED LATER THE SAME DAY THERE WERE NO MALFUNCTIONS AND ¿IMPEDANCES WERE FINE AND THERAPY WAS FINE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351037 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR