BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE, ULTRA SMALL, MEDIUM

    MDR report key: 1931215 · Received November 16, 2010

    Report

    Report Number
    2021898-2010-00290
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 17, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K873247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED TO THE MFR. MEDTRONIC NEUROSURGERY HAS REC'D NO PREVIOUS COMPLAINTS FOR THIS LOT AND A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHUNT HAD A MALFUNCTION PRIOR TO THE IMPLANTATION. THERE WAS NO USE ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALVE, ULTRA SMALL, MEDIUM JXG MEDTRONIC NEUROSURGERY NA C51072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA