BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOS PROG INFANT VALVESYSTEM

    MDR report key: 11415341 · Received March 4, 2021

    Report

    Report Number
    3013886523-2021-00100
    Event Type
    Injury
    Date Received
    March 4, 2021
    Report Date
    March 31, 2021
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION: DHR - LOT NUMBER 4113061, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, NO DEFECTS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO OVERDRAINAGE ISSUES WERE NOTED.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED OVER DRAINAGE OF A MEDOS INFANT VALVE SYSTEM: THE VALVE WAS IMPLANTED ON (B)(6) 2020 AND EXPLANTED ON (B)(6) 2021 DUE TO OVER DRAINAGE ALTHOUGH THE SHUNT WAS ADJUSTED TO A HIGHER PRESSURE. THE VALVE WAS REPLACED TO A NEW HAKIM MEDOS AND THE PATIENT IS IN CLINICAL STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312173 MEDOS PROG INFANT VALVESYSTEM CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 4113061

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR