BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1061525 · Received June 17, 2008

    Report

    Report Number
    6000030-2008-03311
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    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

    RESULTS CODE: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO END OF LIFE. THE CATHETER WAS BROKEN AND WAS ALSO REPLACED. NO PT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER| IMPLANTED:| CATHETER: MODEL #: 8703W| EXPLANTED: