BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOS PROG INFANT VALVESYSTEM

    MDR report key: 11854386 · Received May 20, 2021

    Report

    Report Number
    3013886523-2021-00226
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    May 3, 2021
    Report Date
    July 23, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - LOT CLCCL2 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN THE SILICONE HOUSING WERE NOTED, AND THE UNITIZED CATHETER WAS CUT/TORN. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 200MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLES. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD 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 ROOT CAUSE FOR THE CUT/TEAR IN THE UNITIZED CATHETER WAS PROBABLY DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE CATHETER AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE POSSIBLE ROOT CAUSE FOR THE DEVIATION OF THE ABDOMINAL CATHETER WAS PROBABLY THE INCREASE IN HEIGHT OF THE PATIENT AND THE OCCURRENCE OF GRAVITATIONAL FORCE AS REPORTED BY THE CUSTOMER.

    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

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00227. A PHYSICIAN REPORTED THAT IN 2001, A CODMAN HAKIM PROGRAMMABLE VALVE WAS IMPLANTED TO A (B)(6) YEAR-OLD FEMALE PATIENT VIA V-P SHUNT WITH A SETTING OF 100 MMH20. ON (B)(6) 2021, THE PATIENT COMPLAINED OF A HEADACHE. CONFIRMATION VIA MRI SHOWED THAT THE CATHETER HAD FALLEN OFF AND A SLIT-LIKE VENTRICLE WAS NOTED. ONLY THE VALVE WAS REPLACED ON (B)(6) 2021. THE IMPLANTED ABDOMINAL CATHETER WAS EXTENDED BY USING A CONNECTOR (823053) AND BACTISEAL (823073). THE CAUSE OF THE DEVIATION OF THE ABDOMINAL CATHETER WAS THE INCREASE IN HEIGHT OF THE PATIENT AND THE OCCURRENCE OF GRAVITATIONAL FORCE. THE PATIENT¿S CONDITION HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755974 MEDOS PROG INFANT VALVESYSTEM CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR