BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS ELECTRONIC TOOL KIT

    MDR report key: 25330489 · Received May 29, 2026

    Report

    Report Number
    3014334038-2026-00038
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K181902
    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.

    Description of Event or Problem · 0

    2 OF 2 REPORTS (SAME EVENT/DIFFERENT PRODUCTS). OTHER MFT REPORT NUMBER: 3013886523-2026-00123. A PHYSICIAN REPORTED A CERTAS VALVE WAS PLACED ON (B)(6) 2025. THE PHYSICIAN EXPERIENCED ISSUES CHECKING THE VALVE SETTING AND PROGRAMMING IT WITH THE ELECTRONIC PROGRAMMER (ID (B)(4)). ON (B)(6) 2026, THEY TRIED TO ADJUST THE VALVE; HOWEVER, THE ELECTRONIC PROGRAMMER DID NOT APPEAR TO CHANGE. THE PHYSICIAN WANTED TO MOVE IT FROM 7 TO 8, BUT IT WOULD NOT MOVE. IT IS POSSIBLE THE VALVE MALFUNCTIONED AND BECAME STUCK AND UNABLE TO PROGRAM. IT IS ALSO POSSIBLE THERE WAS AN ISSUE USING THE ELECTRONIC PROGRAMMER (A MAGNET COULD HAVE BEEN INTERFERING OR SOMETHING ELSE COULD BE WRONG WITH THE PROGRAMMER). THE PLACEMENT OF THE VALVE FOR THIS PATIENT WAS ALSO A LITTLE MORE DIFFICULT SINCE IT WAS MORE BEHIND THE EAR THAN ON THE TOP OF THE HEAD. OUT OF CAUTION AND TO ADDRESS THE PATIENT¿S CONCERN, THE VALVE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY SPECIFIC SYMPTOMS PRIOR TO REPLACING THE VALVE. THE PATIENT IS DOING WELL. THE PATIENT IS HUMAN IMMUNODEFICIENCY VIRUS (HIV) POSITIVE. THE ELECTRONIC PROGRAMMERS WERE TESTED USING A DEMO SHUNT, AND THEY ALL WORKED WELL. HOWEVER, IT WAS NOTICED THAT THE PLASTIC FACING ON THE PROGRAMMER HAS SHIFTED AND IMPACTS TURNING THE MAGNET. IT IS NOT KNOWN IF THEY WERE DROPPED OR WHAT CAUSED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152269 CERTAS PLUS ELECTRONIC TOOL KIT INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1