BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 1923232 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09148
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S RECHARGEABLE NEUROSTIMULATOR WOULD NOT RECHARGE ABOVE 50%. THE DEVICE WAS WORKING NORMALLY EXCEPT FOR THE RECHARGING ISSUE. THE PT DID NOT EXPERIENCE ANY INJURY OR SYMPTOMS. IT WAS LATER REPORTED THAT THE DEVICE WAS TOO DEEP IN THE POCKET. THE PT TRIED TO MANIPULATE THE DEVICE IN THE POCKET AND THIS RESOLVED THE CHARGING ISSUE. THE PT WAS ABLE TO FULLY RECHARGE THE DEVICE. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 40 YR