BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5

    MDR report key: 2982016 · Received February 8, 2013

    Report

    Report Number
    2021898-2013-00042
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION HAS NOT BEEN COMPLETED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS FOUND TO BE LEAKING DURING PRE-IMPLANTATION TESTING. ACCORDING TO THE REPORT, THE PHYSICIAN CHANGED THE SET TO COMPLETE THE OPERATION. NO IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55386 DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D18007

    Patients

    Seq Age Sex Outcome Treatment
    1