BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE

    MDR report key: 12409075 · Received September 1, 2021

    Report

    Report Number
    3013886523-2021-00383
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 28, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K041296
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 823164 WITH 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 80MMH2O. THE VALVE WAS HYDRATED. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. 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 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 OCCLUSION ISSUES WERE NOTED.

    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

    A PHYSICIAN REPORTED A SUSPECTED OBSTRUCTION OF A CODMAN HAKIM PROGRAMMABLE IN-LINE VALVE. THE VALVE WAS IMPLANTED IN A PATIENT VIA A VENTRICULAR PERITONEAL SHUNT ON AN UNKNOWN DATE WITH AN UNKNOWN INITIAL SETTING. OBSTRUCTION WAS SUSPECTED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2021 AND THE VALVE WAS REPLACED. NO INFORMATION OF SURGICAL DELAY WAS AVAILABLE. THE PROTEIN LEVEL WAS 873. THE PATIENT IS CURRENTLY IN FOLLOW-UP. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302920 PROG VALVE INLINE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 113382

    Patients

    Seq Age Sex Outcome Treatment
    1