BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA DISPOSABLE DRAINAGE SYSTEM

    MDR report key: 2852397 · Received November 13, 2012

    Report

    Report Number
    2021898-2012-00375
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SYSTEM WAS PATENT AND PASSED LEAK TESTING. ALTHOUGH PROTEINACEOUS DEBRIS WAS FOUND IN THE MALE LUER LOCK OF THE 12" BLUE STRIPE TUBING AND THE PROXIMAL ARM OF THE STOPCOCK/MOUNTING CLIP ASSEMBLY WAS SLIGHTLY BENT (NO CRACKING WAS PRESENT), THESE FACTORS DID NOT COMPROMISE THE FUNCTIONALITY OF THE DEVICE DURING ANALYSIS. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. IT IS UNK WHAT CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN FOUND THE EDM DEVICE WAS LEAKING WHILE PERFORMING A LUMBAR PUNCTURE DURING SURGERY. IT WAS REPLACED WITH A NEW DEVICE TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA DISPOSABLE DRAINAGE SYSTEM JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 46700 12208012

    Patients

    Seq Age Sex Outcome Treatment
    1