BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE RIGHT ANGLE

    MDR report key: 10837521 · Received November 13, 2020

    Report

    Report Number
    3013886523-2020-00189
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    October 20, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - D4, D10, G4, G7, H2, H3, H4, H6, H10 UNIQUE DEVICE IDENTIFIER (UDI) : (01)10886704041849(17)211130(10)111120 THE VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - LOT 111120, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, NEEDLE HOLES IN THE NEEDLE CHAMBER WERE 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 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 CATHETER AND THE VALVE MECHANISM, BUT NO FUNCTIONAL ISSUES WERE NOTED DURING THE INVESTIGATION.

    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

    A PHYSICIAN REPORTED A BLOCKED/OCCLUDED VALVE ON (B)(6) 2020. A CODMAN HAKIM PROGRAMMABLE RIGHT-ANGLE VALVE AND UNITIZED DISTAL CATHETER WAS IMPLANTED VIA A VENTRICULOPERITONEAL SHUNT ON AN UNKNOWN DATE. THE INITIAL SETTING WAS UNKNOWN. ON AN UNKNOWN DATE, ¿OCCLUSION WAS SUSPECTED, AND IT WAS FOUND BY SHUNT CONTRAST THAT FLOW TO THE DISTAL SIDE FROM THE VALVE COULD NOT BE CONFIRMED.¿ IT IS UNKNOWN IF THE PATIENT WAS EXPERIENCING ANY SYMPTOMS RELATED TO THE SHUNT OCCLUSION. THE VALVE WAS REMOVED ON (B)(6) 2020. NO REPLACEMENT WAS PERFORMED. THE PATIENT IS FOLLOWING UP WITH THE PROVIDER POST THE REMOVAL OF THE SHUNT VALVE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301685 PROG VALVE RIGHT ANGLE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1