BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR CATHETER ACCESSORY KIT (LCAK)

    MDR report key: 1031208 · Received April 18, 2008

    Report

    Report Number
    9612007-2008-00015
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 9, 2008
    Report Date
    April 19, 2008
    Manufacturer
    INTEGRA LIFESCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALSO SEE MFR REPORT # 9612007-2008-00016. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A LUMBAR CATHETER FROM A LUMBAR CATHETER ACCESSORY KIT (LCAK) WAS PLACED IN A PT PRIOR TO SURGERY FOR AN ANEURYSM. THE PT DEVELOPED A FEVER ABOUT SIX HOURS AFTER INSERTION, AND SURGERY WAS NOT PERFORMED. A SECOND PHYSICIAN, AN ALLERGIST REPORTED THAT THE PT HAD A SECOND CATHETER (SEE MFR REPORT # 9612007-2008-00016) FROM A LCAK INSERTED. AGAIN SIX HOURS AFTER PLACEMENT, THE PT DEVELOPED A FEVER AND NUMBNESS IN THE LEGS. INCREASED NEUTROPHILS IN THE CEREBROSPINAL FLUID WERE OBSERVED, BUT CULTURES CAME BACK NEGATIVE. THERE WAS NO SKIN RASH. THERE WAS NO EVIDENCE OF ALLERGIC REACTION. THE CARDIOTHORACIC SURGEON REPORTED THAT HE GAVE PROPHYLACTIC ANTIBIOTICS AFTER THE SECOND INSERTION AND SUBSEQUENT FEVER REACTION. NO POSITIVE BACTERIAL CULTURES WERE OBTAINED. A REPORTING PHYSICIAN QUESTIONS THAT THERE MAY HAVE BEEN A BARIUM REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR CATHETER ACCESSORY KIT (LCAK) LUMBAR DRAINAGE CATHETER JXG INTEGRA LIFESCIENCES IMPLANTS S.A. 910-121 0145995

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization