BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1872610 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07882
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    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

    A PT WAS PLACED UNDER GENERAL ANESTHESIA FOR AN IMPLANT PROCEDURE. PRIOR TO IMPLANTING, IT WAS DISCOVERED THAT THE PUMP RECEIVED WAS MISLABELED AS A 40 ML RESERVOIR PUMP, WHEN IT WAS ACTUALLY A 20 ML RESERVOIR PUMP. THE PHYSICIAN/REPORTER VERIFIED THE MODEL AND CALIBRATION CONSTANT, AND IT WAS CLEAR THAT THE PACKAGE WAS LABELED INCORRECTLY. THE IMPLANT PROCEDURE HAD TO BE STOPPED (PUMP WAS NOT IMPLANTED), AND A NEW IMPLANT DATE WAS UNCERTAIN BECAUSE OF PRIVATE CIRCUMSTANCES OF THE PT. IT WAS NOTED THAT THEIR WAS NO PT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR