BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 15412546 · Received September 13, 2022

    Report

    Report Number
    3013886523-2022-00421
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 29, 2022
    Report Date
    October 19, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519164
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823113) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3113 WITH LOT 5775694 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING, THE VALVE FAILED THE TEST. THE SILICONE WAS CUT JUST AFTER THE VALVE CASING AND THE CAM MECHANISM WAS GENTLY MOVED. THE VALVE WAS RETESTED FOR PROGRAMMING, THE VALVE FAILED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BUMP MARK WAS NOTED IN THE VALVE CASING. THE CAM MAGNETS WERE CONTROLLED AND FAILED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE VALVE RECEIVING A HARD KNOCK AND ABNORMAL POLARIZATION OF THE CAM MAGNETS. THE ROOT CAUSE FOR THE BUMP MARKS IN THE VALVE CASING NOTED DURING THE INVESTIGATION IS DUE TO THE VALVE RECEIVING A HARD KNOCK. THE ROOT CAUSE FOR THE ABNORMAL POLARIZATION NOTED DURING THE INVESTIGATION, WAS PROBABLY CAUSED BY AN EXPOSITION OF A TOO STRONG MAGNETIC FIELD, AS NOTED IN THE IFU, ¿ANY MAGNET MAY EXPERIENCE A DEGRADATION OF MAGNETIC FIELD STRENGTH AS A CONSEQUENCE OF EXPOSURE TO THE SIGNIFICANTLY STRONGER MAGNET FIELD INDUCED IN A MRI PROCEDURE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED ON (B)(6) 2021 FOR A CEREBROSPINAL FLUID DIVERSION. THE NEUROSURGEON WAS UNABLE TO REPROGRAM THE SHUNT. THEREFORE, IT WAS REMOVED AND REPLACED ON (B)(6), 2022.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664792 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823113 5775694 10381780519164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown