BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 12291732 · Received August 6, 2021

    Report

    Report Number
    3013886523-2021-00352
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 30, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K041296
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10 THE HAKIM VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 823162 WITH LOT 4772341 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED. SOME NEEDLE HOLES WERE NOTED THROUGH NEEDLE CHAMBER. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. 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 PROBLEM 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

    N/A.

    Additional Manufacturer Narrative · 1

    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 · 1

    1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2021-00353, 3013886523-2021-00354. A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED TO A PATIENT VIA V-P SHUNT THIS YEAR WITH AN UNKNOWN SETTING. ENLARGEMENT OF VENTRICLES WAS CONFIRMED, THEREFORE, THE SET PRESSURE WAS CHANGED. AFTER SEVERAL DAYS THERE WAS NO CHANGE IN THE VENTRICLES AND THE SHUNT WAS REPLACED ON (B)(6) 2021. THE PATIENT IS IN STABLE CONDITION. THE DEVICE WAS USED WITH 823073(SERIAL: UNK) AND 823072(SERIAL; UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183847 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4772341

    Patients

    Seq Age Sex Outcome Treatment
    1