BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2040913 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02219
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2011
    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).

    Description of Event or Problem · 1

    THE EXPECTED RESIDUAL VOLUME OF THE PUMP RESERVOIR WAS 2 MLS; THE ACTUAL VOLUME WAS 19 MLS. THERE WERE NO ALARMS. NO DIAGNOSTIC STUDIES HAD BEEN PERFORMED AT THE TIME OF THE COMPLAINT. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N185651020