BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1374334 · Received May 4, 2009

    Report

    Report Number
    2182207-2009-03102
    Event Type
    Injury
    Date Received
    May 4, 2009
    Date of Event
    May 1, 2009
    Report Date
    April 13, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    LITERATURE: VAN RIJN MA, MUNTS AG, MARINUS J, ET AL. INTRATHECAL BACLOFEN FOR DYSTONIA OF COMPLEX REGIONAL PAIN SYNDROME. PAIN. 2009; 143(1-2): 41-47. SUMMARY: THIS STUDY LOOKED AT THE EFFICACY OF INTRATHECAL BACLOFEN (ITB) IN PTS WITH COMPLEX REGIONAL PAIN SYNDROME (CRPS)-RELATED DYSTONIA AND TO EVALUATE, IF ITB IS EFFECTIVE AND SAFE IN THIS POPULATION OVER A 12-MONTH PERIOD. FIFTY-SEVEN CRPS PTS WERE ASSESSED FOR ELIGIBILITY BETWEEN JANUARY 2002 AND JANUARY 2007, 42 PTS WERE ELIGIBLE TO PARTICIPATE. AFTER PUMP IMPLANT, IT WAS REPORTED THAT THERE WAS CATHETER DISLODGEMENT. DYSTONIA GRADUALLY WORSENED OVER A 2 WEEK PERIOD. THE PT IMPROVED OVER TIME POST CATHETER REVISION. SEE MANUFACTURER REPORT NUMBER: 2182207200903083.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL CATHETER| EXPLANTED: