BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2963698 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02700
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALY. ONLY PARTIAL CATHETER WAS RETURNED. THERE WERE LEAKS OBSERVED BETWEEN THE METAL PIN AND WHITE MATERIAL.

    Description of Event or Problem · 1

    THE DEVICES WERE RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO RETURN PAPERWORK. THE DEVICES UNDERWENT ROUTINE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69331 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1