BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 14497755 · Received May 25, 2022

    Report

    Report Number
    3013886523-2022-00219
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 6, 2022
    Report Date
    July 13, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041559
    PMA / PMN Number
    K041296
    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 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT CMHCZ6, 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 WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE FAILED, THE CAM MECHANISM WRIGGLED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE WAS RETESTED FOR PROGRAMMING AND PASSED THE TEST. THE VALVE PASSED THE TEST FOR OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE CAM MECHANISM. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, WAS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A PROG VALVE INLINE W SG (ID 823162) WAS IMPLANTED VIA V-P SHUNT OVER 10 YEARS AGO WITH 110 MMH2O. THE SET PRESSURE WAS NOT CHANGED, THEREFORE AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE FROM 110MM H2O TO 90 MM H2O, HOWEVER, IT COULD NOT BE CHANGED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO THE ISSUE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094853 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3162 10886704041559

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown