BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1374343 · Received May 4, 2009

    Report

    Report Number
    2182207-2009-03113
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: VAN RJIN 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 PATIENTS 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 PATIENTS WERE ASSESSED FOR ELIGIBILITY BETWEEN 2002 AND 2007, 42 PATIENTS WERE ELIGIBLE TO PARTICIPATE. AFTER IMPLANT, IT WAS REPORTED THAT THERE WAS A PUMP POCKET INFECTION RESULTING IN THE EXPLANTATION OF THE DEVICE. THE PATIENT WAS SUBSEQUENTLY RE-IMPLANTED. 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 Required Intervention CATHETER: MODEL CATHETER| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER| IMPLANTED: