BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3092736 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07299
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 22, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V821660, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V821660, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; 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 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT A RETURNED OF TREMOR WAS NOTICED "ABOUT A MONTH AGO OR SO" FOLLOWING A FALL. IT WAS INDICATED THAT THE DEVICE "MAY HAVE BEEN DAMAGED." IT WAS NOTED THAT THE PATIENT HAD MORE THAN ONE FALL IN THE PAST. THE PATIENT REPORTEDLY HAD "MORE" TREMOR ON THE LEFT SIDE AND THE TREMORS WERE "QUITE FREQUENT, MORE SO THAN NORMAL." ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193831 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1