BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1935933 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10194
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    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 F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    REC'D INFORMATION THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN WAS NOT ABLE TO INSERT THE EXTENSION INTO CHANNEL 1 (CONTACTS 0-7), WHILE THE SAME EXTENSION COULD BE PLUGGED WITHOUT PROBLEMS IN THE CHANNEL 2 (CONTACTS 8-15). A NEW ACTIVA INS WAS USED AND THE PROBLEM WAS SOLVED. IT WAS POSSIBLE TO PLUG THE EXTENSIONS SO THE WHOLE SYSTEM WAS IMPLANTED. THE PT SUFFERED NO INJURY AND IS OKAY.

    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 70 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN012022V| EXTENSION: MODEL 37085, LOT# NKN012020V