BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1053228 · Received May 28, 2008

    Report

    Report Number
    6000030-2008-02844
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0957-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 'SIGNIFICANT' RESERVOIR VOLUME WAS DISCOVERED AT A PUMP REFILL VISIT. A ROTOR STUDY WAS DONE (DATE NOT REPORTED) AND IT APPEARED A STALL HAD OCCURRED. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO ADMINISTER FENTANYL, BACLOFEN, CLONIDINE, AND MARCAINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PROGRAMMER MODEL UNK LOT# UNK| CATHETER MODEL 8598 LOT# UNK| IMPLANTED| EXPLANTED| CATHETER MODEL UNK LOT# UNK| EXPLANTED| IMPLANTED