BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4220650 · Received November 3, 2014

    Report

    Report Number
    3007566237-2014-03206
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    November 15, 2013
    Report Date
    October 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS 3007566237. ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING SITE ID IS 9614453.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DECUBITUS AT THE IMPLANTABLE NEUROSTIMULATOR SITE. A REVISION WAS REQUIRED AND THE PATIENT WAS DOING WELL FOLLOWING THE REVISION. THEY WERE RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700954 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention