BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERTAS VALVE

    MDR report key: 4122642 · Received September 26, 2014

    Report

    Report Number
    1226348-2014-12008
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 22, 2014
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE PATIENT HAS CERTAS IMPLANTED SINCE (B)(6) 2013. IT WAS SET AT 4 BACK THAN WITH SG. IN (B)(6) 2014 IT WAS CHANGED TO 2. SINCE THE (B)(6), PATIENT HAD ISSUES AND CAME IN TO SEE THE DOCTOR. AFTER SEVERAL VERIFICATIONS SURGEON WAS SURE THAT VALVE WAS SET AT 4 AND NOT AT 2 ANYMORE. STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602024 UNKNOWN CERTAS VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention