BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 466793 · Received June 17, 2003

    Report

    Report Number
    6000030-2003-00508
    Event Type
    Injury
    Date Received
    June 17, 2003
    Report Date
    May 27, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP STATES THE PATIENT PRESENTED IN 01/2003 WITH AN EMPTY PUMP. THERE SHOULD HAVE BEEN 5CC REMAINING. IN 02-2003 THE PUMP WAS EMPTY AGAIN WHEN IT SHOULD HAVE HAD 3.7CC REMAINING. IN 05/2003 THERE WAS 1.5CC WITHDRAWN FROM THE PUMP THERE SHOULD HAVE BEEN 11.9CC. THE HCP NOTED THAT THE PATIENT WAS "SLEEPY," LIVES ABOVE 4,000 FEET, AND HAS BEEN USING A HEATING PAD OVER THE PUMP AREA. A PUMP MYELOGRAM WAS DONE-UNKNOWN DATE OR RESULTS. IN 05/2003 THE PUMP WAS EXPLANTED, REPLACED, AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. UPON EXPLANT, IT WAS NOTED THAT AN INFECTION WAS "BEGINNING" IN THE PUMP POCKET. THE PATIENT WAS NOTED AS BEING "ALERT WITH A WELL-HEALED INCISION" AND HAVING "NO FEVER, NO CHILLS, AND NO HEADACHES" AT THE POST REPLACEMENT FOLLOWUP VISIT.

    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 48 YR Other CATHETER MODEL 8709 LOT# J11210R43 IMPLANTED: 2002| EXPLANTED: 2003.