BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 472634 · Received July 17, 2003

    Report

    Report Number
    6000030-2003-00606
    Event Type
    Other
    Date Received
    July 17, 2003
    Date of Event
    July 10, 2003
    Report Date
    July 11, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PUMP WAS EXPLANTED AND LATER REPLACED DUE TO AN INFECTION. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 8627L10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other CATHETER MODEL 8711 LOT# J11349R42 IMPLANT: 2002| EXPLANTED: UNK.