BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE

    MDR report key: 15148288 · Received August 2, 2022

    Report

    Report Number
    3013886523-2022-00358
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    May 9, 2022
    Report Date
    November 18, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041566
    PMA / PMN Number
    NI
    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 823164) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) : THE PRODUCT CODE 82-3164 WITH LOT 212888, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 50MMH2O. THE VALVE WAS HYDRATED. THE CATHETERS WERE IRRIGATED NO OCCLUSIONS NOTED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX 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 FUNCTIONAL 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

    1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00359. A PHYSICIAN REPORTED A HAKIM PROGRAMMABLE VALVE WAS IMPLANTED IN A 15 YEAR-OLD MALE PATIENT TO TREAT AQUEDUCTAL STENOSIS WITH HYDROCEPHALUS BUT LATER DEVELOPED BILATERAL SUBDURAL COLLECTIONS. THE SUBDURAL COLLECTIONS WERE EVACUATED, SHUNT WAS REVISED AND CHANGED TO A PROGRAMMABLE VP SHUNT WITH PRESSURE AT 70MMH2O ON (B)(6) 2022. THEN PATIENT DEVELOPED RECURRENCE OF BILATERAL SUBDURAL COLLECTION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE HE UNDERWENT ON A RE- EVACUATION OF SUBDURAL HEMATOMA ON (B)(6) 2022 AND PRESSURE SETTING WAS INCREASED TO 110MM. HE UNDERWENT A REPEAT CT IMAGING THAT SHOWED NO SIGNIFICANT INCREMENT IN VENTRICLE SIZE AND HENCE PRESSURE SETTING WERE AGAINST CHANGED TO 140 AND LATER TO 200. HE ALSO UNDERWENT REPEAT EVACUATION OF BILATERAL SUBDURAL HEMATOMA ON (B)(6) 2022 BECAUSE OF SHUNT OVER DRAINAGE. REPEAT IMAGING ARE SUGGESTIVE THAT THE PRESSURE CHANGES IN THE SHUNT ARE NOT WORKING AND HENCE SHUNT WAS LIGATED ON (B)(6) 2022 THE VALVE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079271 PROG VALVE INLINE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3164 212888 10886704041566

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown