BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA BURR HOLE VALVE, PERFORMANCE LEVEL 1, 16 MM

    MDR report key: 2111716 · Received May 25, 2011

    Report

    Report Number
    2021898-2011-00093
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K934545
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. NO IMPACT TO THE PT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A VALVE REVISION WAS PERFORMED. ACCORDING TO THE REPORT, THE VALVE WAS FOUND TO HAVE A CRACK OVER THE DELTA CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA BURR HOLE VALVE, PERFORMANCE LEVEL 1, 16 MM JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R