BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 16945954 · Received May 17, 2023

    Report

    Report Number
    3013886523-2023-00156
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    April 28, 2023
    Report Date
    July 12, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10 THE CERTAS VALVE (ID 828806) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER; AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED; 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 MECHANISM. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    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.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS PLUS (ID 828806) WAS IMPLANTED VIA LUMBAR PERITONEAL (L-P) SHUNT IN (B)(6) 2023 WITH SETTING 2. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). ON (B)(6) 2023, AN ATTEMPT WAS MADE TO CHANGE FROM SETTING 2 TO 3 USING ELECTRONIC TOOL KIT (ETK), BUT IT COULD NOT BE CHANGED. THE PATIENT HAD HEADACHE. AT THE PHYSICIAN'S DISCRETION, THE ELECTRONIC TOOL KIT (ETK) ADJUSTER AND THE CERTAS TOOK KIT ADJUSTER WERE OVERLAPPED TO STRENGTHEN THE MAGNETIC FIELD, AND THE SETTING WAS SUCCESSFULLY CHANGED FROM 2 TO 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830029 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Male