BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1872589 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07867
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SET SCREWS ROTATED IN THE POLYMER BOND, THUS TWISTING THE BRAIN LEAD. THE BOOT HAD TO BE CUT OFF TO TRY AND SAVE THE LEAD. THE IMPEDANCE WAS TESTED, AND IT WAS NORMAL. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V425792| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008929V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN008930V| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V425792| EXPLANTED:| STIM ACCESSORY: MODEL 3550-05, LOT# UNK| PROGRAMMER: MODEL 37642, LOT# NJZ105610N| IMPLANTED:| IMPLANTED: