BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKER II EDMS

    MDR report key: 4540276 · Received February 24, 2015

    Report

    Report Number
    2021898-2015-00076
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Report Date
    January 27, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS LATER IDENTIFIED THAT THESE EVENTS HAVE ALREADY BEEN REPORTED TO MEDTRONIC NEUROSURGERY. THEREFORE, THIS IS NOT A NEW EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AN UNKNOWN NUMBER OF BECKER II EDMS DEVICES WERE FOUND TO BE BROKEN AT THE DRAINAGE BAG LUER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129848 BECKER II EDMS DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1