BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1051447 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02722
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 22, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PUMP HADE A VOLUME DISCREPANCY. THE EXPECTED RESERVOIR VOLUME WAS 4 MLS; THE ACTUAL VOLUME WAS 17 MLS. IT WAS AN OLD PUMP; IT DID NOT SHOW AN ALARM OR A BATTERY ALARM DATE. THE PUMP WAS REPLACED. THE PT WAS DOING "OK" AFTER THE REPLACEMENT. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; THE PUMP WAS USED FOR INTRATHECAL SPASTICITY THERAPY. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention