BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 466775 · Received June 17, 2003

    Report

    Report Number
    6000030-2003-00513
    Event Type
    Injury
    Date Received
    June 17, 2003
    Date of Event
    May 21, 2003
    Report Date
    May 24, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PATIENT'S PUMP WAS STARTED (05/2003) AT 2.0 MG/DAY OF MORPHINE. IN 05/2003, THE RATE WAS TURNED UP TO 2.5 MG/DAY. THE PATIENT PRESENTED IN 2003 AT THE OFFICE FEELING CONSTIPATED AND SLUGGISH. DURING THAT VISIT, PATIENT WAS TURNED UP TO 3.0MG/DAY. LATER THE DAY PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PARESTHESIA. THE DRUG WAS CULTURED. NO ORGANISM GROWTH OR CONTAMINANT FOUND. THE PUMP WAS EMPTIED AND REFILLED WITH SALINE. PATIENT WAS GIVEN ORAL MEDICATION FOR PAIN. THE HCP BELIEVES THE PATIENT HAD AN "IDIOPATHIC REACTION" TO THE MORPHINE AND THE THERE IS NOTHING WRONG WITH 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 57 YR Other EXPLANTED: UNK.| CATHETER MODEL 8709 LOT# J11497R42 IMPLANTED: 2003