BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 7068943 · Received November 29, 2017

    Report

    Report Number
    2021898-2017-00615
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 29, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169010789
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE BACKUP WAS UNPACKED, THEY COULD NOT ACHIEVE A PERFORMANCE LEVEL 2.0 BY AN ADJUSTMENT TOOL, AND THE TOOL POINTED AT THE WHITE BELT BETWEEN THE PERFORMANCE LEVEL 2.5 AND 2.0. NONETHELESS, THE PROCEDURE WAS COMPLETED PER THE PHYSICIAN'S DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847569 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44421 E27074 00643169010789

    Patients

    Seq Age Sex Outcome Treatment
    1