BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1884893 · Received October 20, 2010

    Report

    Report Number
    3004209178-2010-08158
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 UPON INSERTION, THE SURGEON FELT THE GUIDEWIRE PULL APART AND IMPLANTED ANOTHER CATHETER. NO FURTHER INFO WAS REQUESTED AT THIS TIME.

    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 37 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N259265003| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N262207009