BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEPDOWN CONNECTOR WITH TUBING

    MDR report key: 2212688 · Received August 11, 2011

    Report

    Report Number
    2021898-2011-00188
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DOCTOR SUSPECTED THAT THE LUMBOPERITONEAL SHUNT SYSTEM WAS NOT SHUNTING NORMALLY. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEPDOWN CONNECTOR WITH TUBING JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C65756

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R