BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 964624 · Received December 7, 2007

    Report

    Report Number
    2182207-2007-04314
    Event Type
    Other
    Date Received
    December 7, 2007
    Date of Event
    November 8, 2007
    Report Date
    November 8, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT TWO WEEKS AGO THE PT'S DRUG CONCENTRATION WAS CHANGED FROM 10 MG/ML TO 20 MG/ML, BUT THE PUMP WAS NEVER UPDATED WITH THE NEW CONCENTRATION. THE HCP IS NOW ALSO ADDING CLONIDINE TO THE PATIENT'S PUMP, AND WAS REQUESTING ASSISTANCE FOR PROGRAMMING A BRIDGE BOLUS FROM 10 MG/ML TO THE NEW 20 MG/ML AND CLONIDINE MIXTURE WITH A DAILY DOSE OF 7 MG/DAY. THE HCP WAS ADVISED THAT THE PT HAS BEEN RECEIVING 14 MG/DAY SINCE THE DRUG CONCENTRATION WAS CHANGED TWO WEEKS EARLIER, BUT AFTER THE 14 HR BRIDGE BOLUS THE PATIENT WOULD BE RECEIVING 7 MG/DAY. THE HCP WAS OK WITH THIS. THE PT REPORTED THAT THE BRIDGE BOLUS WAS PERFORMED AND THE PT WAS INSTRUCTED TO CALL THE HCP IMMEDIATELY IF THEY NOTICED ANY UNUSUAL SYMPTOMS. NO PT SYMPTOMS WERE REPORTED. THE OTHER DRUG IN THE PT'S PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LKK MEDTRONIC NEUROMODULATION PROGRAMMER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED| IMPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8627-18| EXPLANTED| CATHETER MODEL 8709 LOT# N063437001| LOT# NGF035950R