BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3212727 · Received July 9, 2013

    Report

    Report Number
    9614453-2013-01470
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 15, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS FINE AND WAS GETTING AN EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD TURNED OFF AND THE PATIENT PROGRAMMER READ THE ERROR CODE 509. IT WAS STATED THE REPORTER DID A "REST OF THE INS WITH THE RECHARGE SYSTEM." THERE WAS NO INJURY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313339 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1