BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3041338 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04872
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 16, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V451314, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPL ANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V451314, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT POWER ON AND THE SCREEN SHOWED POWER-ON-RESET (POR). IT WAS INDICATED THAT THE PATIENT'S HAND WAS "SHAKING," STATING "THERE WAS A LOT MORE MOVEMENT THAN THERE HAD BEEN FOR A LONG TIME." IT WAS STATED THAT WHILE THE PATIENT WAS BEING GUIDED TO CLEAR THE POR, THE PATIENT WAS ABLE TO SEE THAT THE DEVICE WAS "TURNED OFF." THE DEVICE WAS REPORTEDLY TURNED ON AND THE PROGRAMMER WAS IN SIMPLE MODE, SO THE PATIENT WAS "UNABLE TO SEE ANY SETTINGS." IT WAS NOTED THAT THE PATIENT "HADN'T EVER" CHARGED THE DEVICE HIMSELF. HOWEVER, IT WAS STATED THAT THE "BATTERY LEVEL WAS OKAY." AFTER THE DEVICE WAS TURNED ON, THE PATIENT REPORTEDLY FELT "BETTER." A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143047 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1