BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N'VISION

    MDR report key: 1000062 · Received February 15, 2008

    Report

    Report Number
    2182207-2008-00728
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 19, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT WAS EXPERIENCING "NEUROLOGICAL ISSUES" FOLLOWING A PROGRAMMING ERROR THE DAY BEFORE. A BRIDGE BOLUS WAS BEING PROGRAMMED DUE TO A CHANGE IN MEDICATION CONCENTRATION. THE DRUG USED IN THE PUMP WAS FENTANYL 3800 MCG/ML AT A DOSE OF 2000 MCG/DAY, AND THE NEW DRUG WAS SUFENTANIL 400 MCG/DL AT A DOSE OF 200 MCG/DAY. THE VOLUME BRIDGED WAS 0.485 ML. THE ERROR WAS MADE WHEN THE NEW DAILY DOSE WAS USED IN PLACE OF THE OLD DAILY DOSE. AT THE TIME OF THE REPORT, 148 HOURS WERE REMAINING OF THE INCORRECTLY PROGRAMMED BOLUS. A SINGLE BOLUS OF 132 MCG OVER 15 HOURS WAS PROGRAMMED TO ACCOUNT FOR THE REMAINING VOLUME. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N'VISION LKK MEDTRONIC NEUROMODULATION 8840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863720| CATHETER MODEL 8709 LOT# J11893R23 IMPLANTED| EXPLANTED| LOT# NGP004823N IMPLANTED