BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 13871649 · Received March 24, 2022

    Report

    Report Number
    3013886523-2022-00110
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    March 4, 2022
    Report Date
    May 6, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041481
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 4218853, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED A NEEDLE HOLE IN THE SILICON HOUSING WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED; THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS LEAK TESTED AND LEAK FROM THE NEEDLE HOLE IN THE SILICON HOUSING WAS NOTED. THE SILICON HOUSING WAS CUT AFTER THE VALVE CASING. THE CAM MECHANISM WAS GENTLY MOVED, AND THE VALVE WAS RETESTED FOR PROGRAMMING AND FAILED, THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS DISMANTLED. THE CAM MAGNETS WERE CONTROLLED AND MAGNETS FAILED. THE VALVE WAS VISUALLY INSPECTED AND NO DEFECT WAS NOTED. THE VALVE PASSED THE TEST FOR PRESSURE. ROOT CAUSE - THE ROOT CAUSE FOR THE ABNORMAL POLARIZATION 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 PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED VIA V-P SHUNT ON (B)(6), 2021 WITH UNKNOWN SETTING. ON (B)(6), 2022, IMMEDIATELY AFTER THE MRI EXAMINATION, THE SET PRESSURE CHANGED AND IT BECAME IMPOSSIBLE TO RETURN THE SET PRESSURE TO THE ORIGINAL SETTING. WHEN VPV PROGRAMMER WAS USED, IT GOT AN ERROR MESSAGE AND THE SET PRESSURE WAS CHANGED IN A NARROW RANGE (APPROXIMATELY 120-160MMHG) UNDER FLUOROSCOPY. THE SET PRESSURE WAS SET TO 160MMHG, AND THE PATIENT'S CONDITION DID NOT CHANGE. THE PHYSICIAN DETERMINED THAT THE SHUNT WAS NO LONGER NEEDED AND THE VALVE WAS REMOVED ON (B)(6), 2022. THE PATIENT WAS RECOVERED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863041 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3113 10886704041481

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Female