BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2

    MDR report key: 2041903 · Received March 30, 2011

    Report

    Report Number
    2021898-2011-00074
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT ALLEGEDLY PRESENTED OVERDRAINAGE FROM HIS/HER VENTRICULOPERITONEAL SHUNT. ACCORDING TO THE REPORT, THE DOCTOR TESTED AND CLAIMED THAT THERE WAS SOMETHING WRONG WITH THE VALVE AND REPLACED IT WITH A DIFFERENT VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2 JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R