BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 686259 · Received March 10, 2006

    Report

    Report Number
    6000030-2006-00424
    Event Type
    Malfunction
    Date Received
    March 10, 2006
    Date of Event
    August 12, 2005
    Report Date
    March 10, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED AFTER AN IMPLANT DURATION OIF 66 MONTHS, IT WAS REPLACED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO PATIENT SYMPTOMS OR DEVICE TROUBLESHOOTING PRIOR TO REPLACEMENT SURGERY WAS REPORTED. A FOLLOW UP REPORT WILL BE SENT IF 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 66 YR Hospitalization