BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1226536 · Received November 11, 2008

    Report

    Report Number
    2182207-2008-07347
    Event Type
    Injury
    Date Received
    November 11, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: STETKAROVA I, VRBA I, PEREGIN J, SROUBEK J. COMPLICATIONS OF TREATMENT OF SEVERE SPASTICITY WITH IMPLANTABLE PUMP SYSTEMS. CESKA SLOV NEUROL NEUROCHIR. 2008; 71(4):458-465. THE EFFECT OF INTRATHECALLY ADMINISTERED BACLOFEN WAS TESTED IN 19 PTS WITH SEVERE SPASTICITY AND IN ONE PT WITH GENERALISED DYSTONIA. BASED ON THE EFFECT OF TESTED BACLOFEN, WE SUBSEQUENTLY IMPLANTED PUMP SYSTEMS TO NINE PERSONS WITH MULTIPLE SCLEROSIS AND FIVE PERSONS WITH A CHRONIC SPINAL INJURY. REPORTABLE EVENT: IN TWO OF OUR PTS, WE FOUND THE DISLODGING OF THE CATHETER OFF THE SUBARACHNOIDAL SPACE. SURGICAL REVISION WITH SUBSEQUENT REPLACEMENT OF THE CATHETER WAS NECESSARY. SEE MFG REPORT# 2182207200807345.

    Devices

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

    Patients

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