BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1031343 · Received April 18, 2008

    Report

    Report Number
    6000030-2008-02089
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 20, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0950-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THE SERIAL NUMBER IS INCLUDED IN THE DEVICE IDENTIFICATION RANGE FOR THE SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR PHYSICIAN COMMUNICATION (DATED AUGUST 2007). PUMP MOTOR STALL HAS NOT BEEN CONFIRMED IN THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HAVING A LACK OF THERAPEUTIC EFFECT. DURING REFILL, MORE DRUG WAS TAKEN OUT OF THE RESERVOIR THAN EXPECTED (THE VOLUMES WERE NOT REPORTED). ASPIRATION THROUGH THE SIDE PORT WAS POSSIBLE AND DURING EXPLANTATION OF THE PUMP, THE CATHETER DID NOT SHOW ANY SIGNS OF OCCLUSION. AFTER THE PUMP REPLACEMENT, THE PT WAS REPORTED TO BE DOING "FINE". THE PUMP WAS USED TO DELIVER VENDAL AND CLONIDINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention