BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2012271 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-00797
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE SURGEON ATTEMPTED TO INSERT THE LEFT HEMISPHERE EXTENSION INTO THE SOCKET 1 OF THE NEUROSTIMULATOR HEADER BLOCK BUT WOULD ONLY ADVANCE TO THE FIRST ELECTRODE CONTACT. FURTHER ATTEMPTS TO ADVANCE THE EXTENSION WERE UNSUCCESSFUL. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY INSERT THE EXTENSION INTO THE OTHER SOCKET OF THE DEVICE. THE SURGEON THEN TRIED TO INSERT AN 18 GAUGE NEEDLE INTO THE OBSTRUCTED SOCKET BUT IT WOULD NOT GO PAST THE FIRST ELECTRODE CONTACT POINT. AFTER SEVERAL ATTEMPTS, THE NEEDLE WAS ABLE TO BE FORCEFULLY INSERTED ALL THE WAY IN. IT WAS RECOMMENDED THAT THE DEVICE NOT BE USED (IN CASE THE DEVICE WAS DAMAGED BY THIS) AND A NEW NEUROSTIMULATOR WAS THEN USED. THERE WERE NO PATIENT INJURIES AND HE RECOVERED WITHOUT SEQUELAE.

    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