BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE MICRO

    MDR report key: 10280124 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00195
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    March 27, 2020
    Report Date
    March 27, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D10, G4, G7, H2, H3, H4, H6, H10 UDI: (B)(4). THE VALVE WAS RECEIVED FOR EVALUATION: DHR - LOT NUMBER 3945841, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, A SMALL HOLE IN THE DISTAL CATHETER OVER THE METAL CONNECTOR WAS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. A POSSIBLE ROOT CAUSE FOR THE PROBLEM REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS INTERFERING WITH THE VALVE, NO PRESSURE ISSUE WAS NOTED DURING THE INVESTIGATION OF THE VALVE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: THE ISSUE WAS DISCOVERED AFTER IMPLANTATION AND THE VALVE WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE HAKIM VALVE WAS DRAINING IMPROPERLY: ¿THE PROBLEM IS THAT WE NOW HAD TO DRAIN THE PERITONEAL CATHETER AND THEN AN AWFUL LOT OF CEREBROSPINAL FLUID CAME OUT AS IF THE VALVE HAD NOT BEEN CONNECTED UPSTREAM. SO, I WAS WONDERING IF THE VALVE COULD HOLD THE PRESSURE LEVEL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739319 PROG VALVE MICRO CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3945841

    Patients

    Seq Age Sex Outcome Treatment
    1