BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3004954 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03745
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V011797, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V011797, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER TREMORS RETURN TO BOTH SIDES OF HER BODY. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO GET TELEMETRY WITH THE PATIENT PROGRAMMER ON EITHER DEEP BRAIN STIMULATION IMPLANTS. IT WAS STATED THAT THE PATIENT TRIED EVERYTHING POSSIBLE TO GET THE PATIENT PROGRAMMER TO WORK. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107328 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1