BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE

    MDR report key: 14687912 · Received June 14, 2022

    Report

    Report Number
    3013886523-2022-00264
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 27, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041566
    PMA / PMN Number
    K041296
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    HAKIM VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 113382, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS- THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 120MMH2O. THE VALVE PASSED THE TEST FOR PROGRAMMING, FLUSHING, LEAK, REFLUX AND PRESSURE. THE VALVE WAS LEAK TESTED AND IT LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM AT THE TIME OF INVESTIGATION NO FUNCTIONAL ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM PROGRAMMABLE VALVE (823164) WAS IMPLANTED VIA V-P SHUNT WITH UNKNOWN SETTING. OBSTRUCTION WAS SUSPECTED THUS THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. THE PATIENT IS NOW FOLLOWING UP.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687067 PROG VALVE INLINE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3164 113382 10886704041566

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male