BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 450305 · Received March 24, 2003

    Report

    Report Number
    6000030-2003-00245
    Event Type
    Injury
    Date Received
    March 24, 2003
    Report Date
    March 13, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED DUE TO A RETURN OF SPASTICITY. THE PATIENT "FEELS PUMP IS AGAIN MALFUNCTIONING" WITH A RETURN OF SYMPTOMS. THE ADMITTING PHYSICIAN REQUESTED DIAGNOSITCS ON THE PUMP. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization EXPLANTED: UNK.| CATHETER MODEL 8709, LOT#J10908R47, IMPLANTED:2002