BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 2152700 · Received June 22, 2011

    Report

    Report Number
    3004209178-2011-04669
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A POWER ON RESET (POR) OCCURRED. THE INS WAS IN THE BOX AND NEVER IMPLANTED. THE INS WAS BEING CHARGED UP ON (B)(6) 2011 IN PREPARATION FOR AN IMPLANT ON (B)(6) 2011. THERE WAS TROUBLE MAINTAINING A CHARGE AND THE RECHARGER DISPLAYED A POR MESSAGE. AN OVERDISCHARGE OCCURRED. THE INS WAS CHARGED OVERNIGHT AND THE 8840 PROGRAMMER DISPLAYED A POR ERROR CODE OF "0X8". ONCE THE POR WAS CLEARED AND DATE RESET, IT INDICATED THAT THE INS WAS CHARGED FOR 6.3 HRS WITH 8 COUPLING BARS. THE RECHARGE STATS SHOWED A RECHARGE SESSION OF 6.2 HRS WITH BATTERY VOLTAGE AT 2.375 VOLT AND ENDED AT 4.020 VOLT. THE INS WAS NOT USED FOR IMPLANT DUE TO THE CONCERNS OF WHY THE BATTERY DEPLETED SO QUICKLY.

    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 NA Unknown