BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 3242897 · Received July 19, 2013

    Report

    Report Number
    2021898-2013-00245
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT "LOCAL AND SYSTEMATIC INFECTIONS ARE NOT UNCOMMON WITH SHUNTING PROCEDURES." A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT DEVELOPED AN INFECTION AFTER IMPLANTATION OF THE VALVE. ACCORDING TO THE REPORT, THE PATIENT UNDERWENT TREATMENT FOR THE INFECTION. THE REPORT STATED THAT THE PATIENT HAD RECOVERED AND WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338211 STRATA II VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY D39147

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention