BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE

    MDR report key: 20783733 · Received November 26, 2024

    Report

    Report Number
    3013886523-2024-00374
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    October 29, 2024
    Report Date
    March 7, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519249
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    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 823164) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM AND IDENTIFY THE ROOT CAUSE OF THIS ASSUMPTION AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. 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 MALFUNCTION DURING THE USE OF CODMAN PROGRAMMABLE INLINE VALVE. "ON (B)(6) 2024, A PHYSICIAN IMPLANTED CODMAN PROGRAMABLE INLINE VALVE (ID 823164). THE LOT/BATCH NUMBER AND EXPIRY DATE WERE NOT REPORTED. THE DEVICE WORKED FOR 24 HOURS ONLY THEN AUTOMATICALLY STOPPED/BLOCKED (MALFUNCTION OF SHUT CHAMBER). WHILE WORKING THROUGH DIGITALLY, IT WAS FUNCTIONING BUT NOT SPONTANEOUSLY, EVEN AFTER THE PRESSURE WAS REDUCED TO 70 MM/ H²O BY THE PHYSICIAN. IT WAS REPORTED THAT, THERE WAS NO CSF DRAINAGE. PHYSICIAN HAD TO REMOVE THE SHUNT AND CONVERT IT INTO AN EVD." REMARKS: "THE CAUSALITY FOR THE REPORTED EVENT IS CONSIDERED AS NOT ASSESSABLE DUE TO LACK OF INFORMATION REGARDING CIRCUMSTANCES LEADING TO THE EVENT, CO-SUSPECTS, CONCOMITANT MEDICATIONS, INDICATION, CONCURRENT CONDITIONS, RELEVANT MEDICAL HISTORY AND PAST DRUG HISTORY FOR COMPLETE ASSESSMENT."

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575903 PROG VALVE INLINE CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10381780519249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention