BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3201673 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00058
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    January 3, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING DUE TO THE PATIENT MISSED THE REFILL SCHEDULE. THE PATIENT WAS EXPERIENCING WITHDRAWAL, AND IT HAD NOT BEEN RESCHEDULED WHEN THE PATIENT CALLED IN. THE DRUG DELIVERED IN THE SYSTEM WAS UNKNOWN. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303390 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 861718

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR