BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1021061 · Received March 27, 2008

    Report

    Report Number
    2182207-2008-01586
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    March 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: 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.

    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 PATIENTS, 15 WHICH REQUIRED VARIOUS REVISIONS. REPORTABLE EVENT: 4 PATIENTS WITH SLOWLY INCREASING BACLOFEN-RESISTANT SPASTICITY HAD UNSUSPECTED PUMP-CATHETER CONNECTOR DEFECTS (1 OF WHICH WAS A SUBCUTANEOUSLY DISLOCATED I.T. CATHETER).

    Devices

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

    Patients

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