BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE

    MDR report key: 8664653 · Received June 3, 2019

    Report

    Report Number
    1226348-2019-00181
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 20, 2019
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K041296
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR - REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE, PRODUCT CODE 82-3164 WITH LOT 171588 SHOWED AN NR-REPORT WHEN RELEASED TO STOCK ON THE 19TH JANUARY 2018. THE NR REPORT ISSUE HAD NO LINK TO THIS COMPLAINT. FAILURE ANALYSIS:THE VALVE PASSED ALL TESTS. NO ROOT CAUSE COULD BE DETERMINED FOR THE VALVE; AS THE TECHNICIAN WAS UNABLE TO CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). DHR - REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE, PRODUCT CODE 82-3164 WITH LOT 171588 SHOWED AN NR-REPORT WHEN RELEASED TO STOCK ON THE (B)(6) 2018. THE NR REPORT ISSUE HAD NO LINK TO THIS COMPLAINT. IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AND ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR EVALUATION. NUMEROUS ATTEMPTS WERE MADE TO RECOVER THE DEVICE, WITH NO SUCCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH NORMAL PRESSURE HYDROCEPHALUS, UNDERWENT TO V-P SHUNT IN (B)(6) 2018. IN (B)(6) 2018 THE PATIENT NEEDS TO REPLACE THE VALVE DUE TO A FAILURE. ON (B)(6) 2019 THE PATIENT COMPLAINED OF PROGRESSIVE CLINICAL DETERIORATION. THEREFORE, VERIFIED A NEW FAILURE OF THE VALE, IT HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456266 PROG VALVE INLINE CHPV JXG RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1