BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 480699 · Received August 27, 2003

    Report

    Report Number
    6000030-2003-00770
    Event Type
    Death
    Date Received
    August 27, 2003
    Date of Event
    August 4, 2003
    Report Date
    August 4, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF PATIENT IN HOSPITAL ON RESPIRATOR. RESPONDS TO NARCAN. PATIENT HAD A REFILL A WEEK AGO AND HOSPITAL DOCTOR UNSURE WHAT IS PROGRAMMED. HCP SEEKING ASSISTANCE IN MANAGING PUMP. FOLLOW UP WITH REPORTER REVEALED THERE WAS NO INDICATION OF MALFUNCTION OF THE PUMP. THE HOSPITAL STAFF NEEDED HELP IN MANAGMENT OF PUMP AND PROMPT HELP WAS PROVIDED. PATIENT HAD MULTIPLE MEDICAL CONDITIONS AND WAS TAKING MANY ORAL PAIN MEDS. PATIENT DEVELOPED RENAL FAILURE AND HAS PASSED AWAY AS A RESULT OF THEIR MEDICAL DISEASE CONDITIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H CATHETER MODEL 8703W LOT# L49842 IMPLANT 1998| EXPLANT UNK.