BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1061522 · Received June 17, 2008

    Report

    Report Number
    6000030-2008-03302
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 22, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP MOTOR STALLED. THE MOTOR STALL WAS CONFIRMED BY ROTOR STUDY. NO PT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR CATHETER: MODEL 8709| EXPLANTED| PROGRAMMER: MODEL PROGRAMMER| IMPLANTED