BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201422 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00084
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    January 27, 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 DURING PATIENT¿S LAST REFILL, THE REPORTER GOT ALL OF THE DRUGS OUT OF THE PUMP AND THEY WERE ONLY ABLE TO FILL THE PUMP WITH 13 CC OF DRUG. THE REPORTER TRIED ¿PULL BACK FOR FOUR MINUTES,¿ BUT HE STILL COULD NOT FILL THE PUMP. THE PROBLEM ¿GOT WORSE.¿ THE PATIENT HAD ANOTHER REFILL ON THE DATE OF THIS REPORT, AND THEY PULLED EVERYTHING OUT, BUT THEY COULD NOT GET ANYTHING BACK INTO THE PUMP. IT WAS LATER REPORTED THAT ¿EVERYTHING WAS WORKING PROPERLY¿ AFTER USING A 5 CC SYRINGE OF SALINE. THE SALINE WAS ¿PUSHED IN AND THEN ASPIRATED.¿ THE PUMP WAS USED TO DELIVER CLONIDINE, MARCAINE, PRIALT, BACLOFEN AND FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303333 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1