BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 1895318 · Received November 8, 2010

    Report

    Report Number
    3004209178-2010-09007
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION SUDDENLY STOPPED, AFTER WHICH FOR ABOUT SIX MONTHS RECHARGING CAUSED SEVERE "STRANGE SENSATION" AND "A NASTY FEELING" IN THE PT'S HEAD. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| ADAPTER: MODEL 64002, LOT# UNK