BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

    MDR report key: 2156034 · Received July 1, 2011

    Report

    Report Number
    2021898-2011-00138
    Event Type
    Injury
    Date Received
    July 1, 2011
    Date of Event
    June 2, 2010
    Report Date
    June 1, 2011
    Manufacturer
    UNK
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. IT HAS BEEN CONFIRMED THAT THE SAID DEVICE IS A MEDTRONIC NEUROSURGERY PRODUCT.

    Description of Event or Problem · 1

    A REPORT WAS REC'D WHICH ALLEGES THAT A SHUNT MALFUNCTIONED AND FAILED TO OPERATE. THE REPORTER HAD FAILED TO IDENTIFY THE MAKE OR MODEL OF THE SHUNT OR INCLUDE ANY OTHER IDENTIFYING DETAILS. MEDTRONIC HAS CONSEQUENTLY BEEN UNABLE TO IDENTIFY, MUCH LESS OBTAIN AND CONDUCT AN ANALYSIS, REGARDING THE SHUNT IN QUESTION AND/OR THE VALIDITY OF THE REPORTER'S CLAIM OF AN ALLEGED SHUNT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability