BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRHOMED II

    MDR report key: 1242888 · Received November 19, 2008

    Report

    Report Number
    2182207-2008-07587
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    {860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PUMP MOTOR STALL WITH NO RECOVERY RECORDED IN THE EVENT LOGS. A "TUBE SET" MESSAGE OCCURRED TWO DAYS AFTER THE STALL. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR EXPLANTED:| CATHETER: MODEL 8709| IMPLANTED:| PROGRAMMER: MODEL 8840