BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 15419402 · Received September 14, 2022

    Report

    Report Number
    3013886523-2022-00424
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 18, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519232
    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 6317112, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; A NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. 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 OCCLUSION ISSUES WERE NOTED WITH THE VALVE. NO CORRECTIVE ACTION IS REQUIRED GIVEN THAT NO MANUFACTURING, WORKMANSHIP, MATERIAL DEFICIENCY OR ADVERSE TREND WAS IDENTIFIED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED IN A 2 MONTH OLD PATIENT VIA UNKNOWN SHUNT AND DATE. ON (B)(6) 2022, THE PATIENT HAD A SUBCUTANEOUS RETENTION, LARGE FONTANEL SWELLING, FEVER, AND VOMITING. ON (B)(6) 2022, SHUNT IMAGING WAS PERFORMED AND OBSTRUCTION WAS CONFIRMED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. THE PATIENT IS IN FOLLOW UP.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2745613 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823162 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Unknown