BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3960860 · Received July 28, 2014

    Report

    Report Number
    3007566237-2014-02088
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FILLING DIFFICULTIES WERE ENCOUNTERED ON A DEMONSTRATION DEVICE. WHEN FILLING AT THE JUNCTION, A LOT OF FLUID WAS SEEN COMING OUT OF THE PUMP. DIAGNOSTIC TESTING/TROUBLESHOOTING INCLUDED A DYE STUDY. IT WAS REPORTED AS ¿UNKNOWN OR N/A¿ IF THE ISSUE WAS RESOLVED AND THE CAUSE DETERMINED. NO DRUG WAS IN THE PUMP. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER WAS TROUBLESHOOTING WITH A DEMONSTRATION PUMP. REPORTEDLY, IF THE NEEDLE WAS INSERTED ON THE SIDE OF THE PUMP, AT THE JUNCTION, ONE COULD ¿SEE FEEL LIKE THE NEEDLE IS IN¿ AND FLUID COULD BE ASPIRATED. HOWEVER, WHEN FLUID WAS INJECTED IT SLOWLY FLOWED OUTSIDE THE PUMP. ALSO IN THIS SITUATION, EVEN JUST MOVING THE NEEDLE AROUND SEEMED TO MOVE THE JOINT AND LET FLUID OUT. REPORTEDLY, EXPERIENCED HEALTH CARE PROFESSIONALS IN THIS SERVICE WERE FEELING ¿LESS AND LESS AT EASE¿ IN FILLING THESE PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438260 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1