BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 484217 · Received September 15, 2003

    Report

    Report Number
    6000030-2003-00830
    Event Type
    Other
    Date Received
    September 15, 2003
    Date of Event
    August 7, 2003
    Report Date
    August 18, 2003
    Manufacturer
    RICE CREEK MFG.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTS THE PUMP DID NOT "EXTRACT THE QUANTITY OF MORPHINE REQUESTED." THERE WAS NO PT COMPLICATION. "FIRST THE CONNECTION WAS REPLACED, THEN THE CATHETER WAS REPLACED AND THE PUMP WAS CHECKED BY X-RAY." THE PUMP WAS EXPLANTED AND RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW UP REPORT WILL BE SENT WHEN ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MFG. 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other