BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR CATHETER ACCESSORY KIT (LCAK)

    MDR report key: 973681 · Received December 5, 2007

    Report

    Report Number
    9612007-2007-00054
    Event Type
    Injury
    Date Received
    December 5, 2007
    Report Date
    December 5, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    INTEGRA LIFESCIENCES CORP ("INTEGRA") RECEIVED A LETTER FROM THE FDA WITH INFO OF AN ELECTRONIC PRINTOUT OF A MEDWATCH FORM THAT WAS SUBMITTED ON 9/24/07. THE INCIDENT WAS NOT REPORTED TO INTEGRA AT THE TIME OF OCCURRENCE, SO INTEGRA'S AWARE DATE IS 11/9/07, WHICH IS THE RECEIPT DATE OF THE FDA LETTER. CONTACT WAS MADE BY AN INTEGRA REP WITH THE RISK MANAGEMENT DEPT OF THE FACILITY ON 11/16/07, TO OBTAIN COPIES OF THE MEDWATCH FORM THEY FILED WITH THE FDA. A DISCREPANCY IN THE CATALOG NUMBERS HAS BEEN FOUND ON THE MEDWATCH FORM BETWEEN SECTION B (910-120A) AND SECTION E (910-210 WHICH IS NOT A VALID NUMBER). THE PRODUCT DESCRIPTION WHICH IS INTEGRA ACCESSORY KIT LUMBAR CATHETER AND RECENT SALES HISTORY INDICATES LCAK 910-121 IS ROUTINELY ORDERED AND 910-120A WAS ONLY ORDERED AFTER THESE INCIDENTS OCCURRED. THE PRODUCT WAS USED IN CONJUNCTION WITH CODMAN DRAINAGE COLLECTION SYSTEM #82-1731, SO PRODUCT IS MOST LIKELY THE LCAK 910-121. THE MEDWATCH FORM REPORTED THE FOLLOWING INCIDENT: THE CRANIAL SPINAL FLUID ("CSF") DRAIN WAS PLACED BY ANESTHESIA. THE DRAIN MALFUNCTIONED INTRA-OPERATIVELY DURING THE THORACO ABDOMINAL ANEURYSM ("TAA") REPAIR. INTEGRA CSF DRAIN WAS PLACED PRE-OPERATIVELY BY ANESTHESIA TO DRAIN CSF DURING TAA REPAIR. THE REPORTED FAILURES INCLUDE KINKING, CATHETER CLOTTING, AND INABILITY TO FLUSH OR ASPIRE THE CATHETER. THE CATHETERS HAD TO BE REPLACED FOR TWO OF THE THREE PATIENTS. THE INTEGRA DRAINS ARE USED IN CONJUNCTION WITH THE CODMAN DRAINAGE COLLECTION SYSTEM #82-1731. THIS INCIDENT IS RELATED TO MDR NUMBERS 9612007-2007-00053 AND 9612007-2007-00055.

    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. * 0144103

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention CODMAN DRAINAGE COLLECTION SYSTEM #82-1731