BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROG VALVE RIGHT ANGLE

    MDR report key: 17691195 · Received September 6, 2023

    Report

    Report Number
    3013886523-2023-00292
    Event Type
    Death
    Date Received
    September 6, 2023
    Report Date
    October 26, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519263
    PMA / PMN Number
    K041296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID: 823184) 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 COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS. 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. A MEDICAL ASSESSMENT WAS REQUESTED TO OUR MEDICAL SAFETY DEPARTMENT: CONCLUSION: THE NARRATIVE DESCRIBES A PROCEDURALLY RELATED EVENT ONLY. THERE IS NO EVIDENCE THAT SUPPORTS A CAUSAL RELATIONSHIP TO THE DEVICE.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00293 THE PATIENT¿S SON REPORTED A HAKIM VALVE (ID 823184) AND BACTISEAL CATHETER (ID 823072) WERE IMPLANTED IN HIS FATHER IN (B)(6) 2022. ACCORDING TO THE SON, THERE WAS NO INFECTION BEFORE THE OPERATION. HE APPROACHED THE SURGEON DUE TO HIS FATHER¿S WEIGHT REDUCTION AND POOR RESPONSE AT THE END OF (B)(6) 2022, AND HE WAS INFORMED THAT BY ADJUSTING THE PRESSURE, THE PATIENT WILL BE BACK TO NORMAL AND PRESSURE WAS ADJUSTED TWO TIMES (SETTING NOT PROVIDED). THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR MORE THAN 10 DAYS ONLY FOR OBSERVATION AND WAS INFORMED THAT THE PATIENT WILL BECOME NORMAL IN THE TWO WEEKS PERIOD. IN JANUARY 2023, THE PATIENT WAS ADMITTED AGAIN DUE TO POOR RESPONSE AND AFTER 4 DAYS THE PATIENT HAD AN INFECTION. THE SURGEON INFORMED THEM THAT THE PATIENT HAD AN INFECTION AND A MYOCARDIAL INFARCTION (MI). THE PATIENT EXPIRED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224826 PROG VALVE RIGHT ANGLE CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 5885822 10381780519263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death