BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 926828 · Received October 11, 2007

    Report

    Report Number
    2182207-2007-03164
    Event Type
    Other
    Date Received
    October 11, 2007
    Report Date
    September 21, 2005
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: SHIELDS D.C., PALINA C., ET AL. "EXTRAMEDULLARY INTRATHECAL CATHETER GRANULOITIA ADHERENT TO THE CONUS MEDULLARIS PRESENTING AS CAUDA EQUINA SYNDROME." ANESTHESIOLOGY. 2005; 102(5) 1059-61. THE CATHETER MANUFACTURER WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SHIELDS D. C., PALINA C., ET AL. "EXTRAMEDULLARY INTRATHECAL CATHETER GRANULOITIA ADHERENT TO THE CONUS MEDULLARIS PRESENTING AS CAUDA EQUINA SYNDROME." ANESTHESIOLOGY. 2005; 102(5) 1059-61. THE ARTICLE DESCRIBES A CASE REPORT INVOLVING A PATIENT BEING TREATED WITH AN IMPLANTABLE INFUSION PUMP AND MORPHINE FOR PAIN ASSOCIATED WITH AN L1 COMPRESSION FRACTURE. THE PATIENT EXPERIENCED NEW ONSET PAIN DUE TO A GRANULOMA AT THE CATHETER TIP AND A MIGRATION OF THE REPLACEMENT CATHETER. REPORTABLE EVENTS: PATIENT EXPERIENCED NEW ONSET NEUROPATHIC PIAN RELATED TO A GRANULOMA FORMATION AT THE TIP OF THE CATHETER (N=1). SEVERAL WEEKS POST CATHETER REPLACEMENT, DUE TO THE GRANULOMA, THE PATIENT EXPERIENCED NEW ONSET PAIN RELATED TO THE MIGRATION OF THE CATHETER (N=1). THE CATHETER WAS REPOSITIONED AND THE PAIN WAS RESOLVED. THE CATHETER MANUFACTURER WAS NOT IDENTIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANTABLE INFUSION PUMP| IMPLANTABLE INFUSION PUMP