BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 15198885 · Received August 10, 2022

    Report

    Report Number
    3013886523-2022-00368
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    July 15, 2022
    Report Date
    October 19, 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 CHJB48, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; THE STATOR WAS DISLODGED BUMP MARKS WERE NOTED IN THE VALVE CASING. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BUMP MARKS WERE NOTED IN THE VALVE CASING, THE CAM MECHANISM STEPS WERE DAMAGED, AND CORROSION WAS NOTED ON THE STATOR. THE CAM MAGNETS WERE CONTROLLED, MAGNETS FAILED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE DISLODGED STATOR THE ROOT CAUSE FOR THE DISLODGED STATOR NOTED DURING THE INVESTIGATION IS DUE TO THE VALVE RECEIVING A HARD KNOCK. THE ROOT CAUSE FOR THE BUMP MARKS IN THE VALVE CASING NOTED DURING THE INVESTIGATION AND THE DAMAGED CAM MECHANISM 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 PHYSICIAN REPORTED A MICRO VALVE WITH RICKHAM RESERVOIR AND UNITIZED DISTAL CATHETER (ID 823113) WAS IMPLANTED IN A FEMALE PATIENT VIA V-P SHUNT ON UNKNOWN DATE WITH 50 MMH2O. SINCE VENTRICULAR ENLARGEMENT WAS CONFIRMED ON (B)(6),2022, AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE, BUT IT WAS NOT POSSIBLE. AFTER THAT, VENTRICULAR ENLARGEMENT DID NOT IMPROVED. DUE TO SUSPICION OF VALVE DAMAGED, THE VALVE WAS REMOVED AND REPLACED ON JULY 25, 2022.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523401 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3113 CHJB48 10886704041481

    Patients

    Seq Age Sex Outcome Treatment
    1 Female