BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR CATHETER ACCESSORY KIT (LCAK)

    MDR report key: 510240 · Received February 5, 2004

    Report

    Report Number
    9612007-2004-00006
    Event Type
    Injury
    Date Received
    February 5, 2004
    Date of Event
    August 2, 2003
    Report Date
    February 5, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO RMA WAS ISSUED, THE DEVICE IS NOT EXPECTED TO BE RETURNED. A PT STATUS POST PITUITARY TUMOR REMOVAL DEVDLOPED A CEREBRAL SPINAL FLUID LEAK AND A LUMBAR DRAIN WAS PLACED. IN 2003 THE PT HAD POSITIVE CEREBRAL SPINAL FLUID FOR CRYPTOCOCCUS UNIGUTTILATUS. THE PT WAS ASYMPTOMATIC AND DID NOT REQUIRE TREATMENT. THE DEVICE WAS IDENTIFIED AS A LUMBAR DRAIN, NO LOT NUMBER OR DEVICE NUMBER WAS IDENTIFIED. A REVIEW OF THE CUSTOMER ACCOUNT PURCHASE RECORDS IDENTIFIED DEVICE AS THE LUMBAR DRAIN PURCHASED BY THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR CATHETER ACCESSORY KIT (LCAK) EXTERNAL DRAINAGE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other