BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 1022239 · Received March 26, 2008

    Report

    Report Number
    2182207-2008-01615
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    March 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ROOSEN ET AL. "ANALYSIS OF SURGICAL INTRATHECAL (I.T.) BACLOFEN (ITB) IMPLANT RESULTS EMPHASIZING REVISION SURGERY IN A MIXED PEDIATRIC/ADULT POPULATION." P54, PROGRAM AND ABSTRACTS, CHILD NEUROLOGY SOCIETY. P S121. THE AUTHORS PROVIDED A RETROSPECTIVE REVIEW OF REVISION SURGERY EXPERIENCED FOR PRIMARY IMPLANTS (IMPLANTED AT THEIR INSTITUTION) AND OPERATIVE REVISIONS FOR CASES ORIGINALLY IMPLANTED OUTSIDE THEIR INSTITUTION. SINCE 2002, THEY TREATED 41 PTS, 15 WHICH REQUIRED VARIOUS REVISIONS. REPORTABLE EVENT: THREE PTS HAD CONNECTOR-RELATED DYE LEAKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER MODEL UNK| IMPLANTABLE INFUSION PUMP MODEL # UNK