BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG VLV ONLY

    MDR report key: 17480505 · Received August 8, 2023

    Report

    Report Number
    3013886523-2023-00246
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 17, 2023
    Report Date
    August 30, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780529378
    PMA / PMN Number
    K182265
    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 CERTAS VALVE (ID: 828814PL) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 5. THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING. THE VALVE WAS DISASSEMBLED AND WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION; BIOLOGICAL DEBRIS WAS FOUND ON THE MOTOR AND THE SPRING. ROOT CAUSE- NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. HOWEVER, 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, AT THE TIME OF INVESTIGATION BIOLOGICAL DEBRIS WAS FOUND ON THE MOTOR AND THE SPRING.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED 3.5 YEARS AGO WITH SETTING 5. USING THE ELECTRONIC TOOL KIT (ETK), MEDICAL STAFF TRIED TO REPROGRAM SHUNT TO SETTING 7, HOWEVER, THE VALVE STAYED AT 5. AFTER MANY ATTEMPTS INCLUDING WITH MULTIPLE ETK KITS AND MAGNETS, THE SETTING REMAINED AT 5. THE LARGE MAGNET COULD NOT MOVE THE SETTING OFF OF 5. THE PATIENT DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS OF VALVE MALFUNCTION AND PHYSICIAN ONLY WANTED TO PROGRAM SETTING 7 AS THE PATIENT HAD A SUBDURAL DUE TO A FALL (THE PATIENT FELL OUT OF BED A FEW WEEKS AGO POSSIBLY DAMAGING THE VALVE). THE VALVE WAS REPLACED ON (B)(6), 2023.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326266 CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 10381780529378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown