BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3120910 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07946
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    May 8, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ¿ALL CHECKED OUT FINE¿ AT THE APPOINTMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER BATTERIES RAN OUT "A COUPLE DAYS AGO". ONCE THE PATIENT PLACED NEW BATTERIES THE PROGRAMMER DID NOT MAKE NOISES. EVERYTHING ELSE WAS NORMAL. A LOSS OF THERAPEUTIC EFFECT WAS REPORTED, AND IT WAS STATED THAT THE PATIENT¿S INS MUST HAVE SOMEHOW GOT TURNED OFF. THE PATIENT COULDN¿T WALK AND ONCE NEW BATTERIES WERE PLACED AND THE INS WAS TURNED ON THE PATIENT EXPERIENCED A "TERRIBLE JOLT" THAT WAS "NOT A PLEASANT EXPERIENCE." IT WAS NOTED THAT THE PATIENT WAS INCREASED TO 3.4V AND WAS FUNCTIONING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222305 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1