BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 472757 · Received July 16, 2003

    Report

    Report Number
    6000030-2003-00593
    Event Type
    Other
    Date Received
    July 16, 2003
    Date of Event
    May 5, 2003
    Report Date
    June 27, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE RETURNED FOR ANALYSIS WITH REPORT THAT "FAMILY DESCRIBES EPISODES OF APPEARING "OVERSEDATED" THEN PERIODS OF WITHDRAWAL." DYE STUDY ATTEMPTED - UNABLE TO ACCESS. FOLLOW UP WITH HCP REVEALED THE PATIENT'S FAMILY WAS NOT HAPPY WITH PROGRESS OF PATIENT. THE FAMILY FELT THE PATIENT HAD PERIODS OF LETHARGY AND TIGHTNESS BUT HCP WAS UNABLE TO FIND A CAUSE RELATED TO FUNCTION OF THE PUMP. PUMP RESIDUAL VOLUMES WERE ACCURATE AND NO ROTOR STUDY WAS DONE. PATIENT HAS UNDERGONE A LONG OBSERVATION/EVALUATION PROCESS. A SECOND OPINION WAS OBTAINED AND THIS HCP ATTEMPTED TO DO A CATHETER STUDY BUT WAS UNABLE TO ACCESS THE PORT. PATIENT'S DOSE WAS REDUCED IN ANTICIPATION OF EXPLANT OF PUMP PER FAMILY CHOICE. PUMP EXPLANTED. PATIENT OUTCOME POST EXPLANT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 862710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization EXPLANT: 2003.| CATHETER: MODEL 8711, LOT# UNK, IMPLANT: UNK,