BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, OPEN TIP

    MDR report key: 4092833 · Received August 21, 2014

    Report

    Report Number
    2648988-2014-00043
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Report Date
    July 30, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INS8330 HERMETIC LUMBAR CATHETER, OPEN TIP STOPPED WORKING AFTER 4 DAYS ((B)(6) 2014) AND LEAKS (CSF) CEREBROSPINAL FLUID. THE PATIENTS' AGE, GENDER AND UNDER LYING MEDICAL CONDITION WAS NOT PROVIDED. THE SURGEON DID NOT REMEMBER THE AMOUNT OF CSF THAT WAS LOST. THE PATIENT DID NOT INCUR AN INJURY BECAUSE OF THIS ISSUE. THE INS8330 CATHETER WAS REMOVED ON (B)(6)2014. ANOTHER CATHETER WAS INSERTED, HOWEVER, IT WAS ANOTHER MANUFACTURERS' PRODUCT. THE DATE IT WAS INSERTED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504567 HERMETIC LUMBAR CATHETER, OPEN TIP NA JXG INTEGRA NEUROSCIENCES PR 113845

    Patients

    Seq Age Sex Outcome Treatment
    1