BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 1860015 · Received September 17, 2010

    Report

    Report Number
    2648988-2010-00065
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 17, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    (B)(4) HERMETIC LUMBAR CATHETER WAS PLACED (POSSIBLY INCORRECTLY -EG NOT FOLLOWING INTEGRA DFU) IN A PATIENT AND THEN WITH SOME DIFFICULTY THE UNIT WAS WITHDRAWN, AT WHICH POINT, PART OF THE CATHETER WAS REPORTED TO HAVE BECOME DETACHED AND REMAINED WITHIN THE PATIENT. THIS LED TO A NEUROSURGEON BEING CALLED AND SURGICALLY REMOVING IT FROM THE PATIENT. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT, HOWEVER, THE PROCEDURE WAS PROLONGED AS A RESULT. (LENGTH OF DELAY UNKNOWN).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention