BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2513827 · Received April 2, 2012

    Report

    Report Number
    3004209178-2012-02019
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Report Date
    March 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3387S-40, LOT # V011138, IMPLANTED: (B)(6) 2008, EXPLANTED: NA; LEAD MODEL 3389S-40, LOT # V090728, IMPLANTED: (B)(6) 2008, EXPLANTED: NA; EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA; EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA; ADAPTOR MODEL 64002, LOT # N303428, IMPLANTED: (B)(6) 2011, EXPLANTED: NA; PROGRAMMER MODEL 37642, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TRAVELING IN (B)(6) AND EXPERIENCED A LOSS OF EFFICACY, LEADING TO LOTS OF FALLS AND SOME PAIN. IT WAS NOT KNOWN IF STIMULATION COULD HAVE BEEN TURNED OFF BY AIRPORT SECURITY. THE REPORTER WAS TO CHECK WITH THE PATIENT AND SEE IF STIMULATION WAS TURNED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1