BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201365 · Received July 2, 2013

    Report

    Report Number
    3007566237-2012-03043
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HEALTH CARE PROFESSIONAL WAS INTERROGATING THE PUMP, THE PUMP WAS ¿STRUGGLING TO GET TELEMETRY AND STRUGGLING TO READ THE ACTUAL PUMP.¿ THE PROGRAMMER MADE ¿KIND OF A FUNKY NOISE, KIND OF SHUT OFF,¿ AND WHEN THE HEALTH CARE PROFESSIONAL WENT TO RE-INTERROGATED IT, THE PUMP HAD STOPPED. THEN THE HEALTH CARE PROFESSIONAL RE-UPDATED THE PUMP, AND IT ¿RAN AGAIN.¿ THE EVENT OCCURRED WHEN THE HEALTH CARE PROFESSIONAL WAS DOING AN UPDATE AFTER REFILL. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PROGRAMMER MALFUNCTIONED AND CAUSED THE PUMP TO GO INTO A STOPPED MODE. THE PUMP WAS RE-INTERROGATED AND RE-UPDATED. EVERYTHING WAS ¿WORKING ONCE THE UPDATE WAS COMPLETED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303138 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1