BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N'VISION

    MDR report key: 1032144 · Received April 21, 2008

    Report

    Report Number
    2182207-2008-02092
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING CATHETER REVISION THE HCP DID NOT WANT TO CHANGE THE DRUG CONCENTRATION, BUT WANTED TO DECREASE THE PT'S DOSE. THE PT'S PUMP WAS PROGRAMMED TO THE LOWEST DOSE AVAILABLE WITH THE 2000 MCG/ML CONCENTRATION OF LIORESAL (96 MCG/DAY), AND THE PT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. THE PT COMPLAINED OF SOME INCREASED FLACCID LEG SYMPTOMS. THE LIORESAL CONCENTRATION WAS CHANGED TO 500 MCG/ML AND THE DOSE WAS DECREASED TO 41 MCG/DAY. THE PT WAS LATER RELEASED HOME, AND RECOVERED WITHOUT SEQUELA. REF MFR REPORT #6000030200801673.

    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 Hospitalization| R IMPLANTED| LOT #NGV004942N| IMPLANTABLE INFUSION PUMP MODEL 863740| EXPLANTED| IMPLANTED| EXPLANTED| CATHETER MODEL 8709 LOT# N143237003