BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 484435 · Received September 15, 2003

    Report

    Report Number
    6000030-2003-00828
    Event Type
    Malfunction
    Date Received
    September 15, 2003
    Date of Event
    August 13, 2003
    Report Date
    August 18, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PT PRESENTED EARLY AS PAIN RETURNED. "PUMP HAS ALWAYS APPEARED TO RUN SLIGHTLY FAST SINCE IMPLANT, I.E. LESS IN RESERVOIR AT REFILL THAN INDICATED ON READOUT" THE PUMP WAS EMPTY BUT THE READOUT INDICATED 5ML WAS THE EXPECTED RESERVOIR VOLUME. 7 HOURS FOLLOWING A ROUTINE REFILL. THE PT EXPERIENCED RESPIRATORY ARREST AND WAS "RESUSCITATED". THE PUMP WAS STOPPED AND EMPTIED, "16 ML LEFT OF THE 18 ML REFILL". THE PUMP WAS SCHEDULED TO BE EXPLANTED IN 2003. IT WAS NOT BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. 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 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R