BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 15869393 · Received November 28, 2022

    Report

    Report Number
    3013886523-2022-00553
    Event Type
    Injury
    Date Received
    November 28, 2022
    Report Date
    March 22, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519164
    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 HAKIN VALVE WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED ON (B)(6) 2022. THE PATIENT CAME IN WITH SHUNT OVER DRAINAGE. MEDICAL STAFF NEEDED TO SET THE VALVE PRESSURE, HOWEVER, THEY WERE UNABLE TO REPROGRAM THE VALVE AFTER MULTIPLE ATTEMPTS AND A VALVE REVISION WAS REQUIRED. OPERATION PERFORMED; "ENDOSCOPIC SEPTOSTOMY AND LEFT FRONTAL KOCHER'S POINT PROGRAMMABLE VP SHUNT UNDER GA."

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713045 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823113 5346513 10381780519164

    Patients

    Seq Age Sex Outcome Treatment
    1 Male