BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS CODMAN

    MDR report key: 8090645 · Received November 19, 2018

    Report

    Report Number
    MW5081503
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 2, 2018
    Report Date
    November 16, 2018
    Manufacturer
    JOHNSON & JOHNSON / INTEGRA LIFESCIENCES
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A CERTAS-CODMAN VENTRICULAR-PERITONEAL SHUNT IMPLANTED (B)(6) 2017 FROM JOHNSON AND JOHNSON AT THE (B)(6). THIS REPLACED A MEDTRONIC STRATA VALVE. MEDTRONIC ALWAYS SUPPLIES AN ID CARD FOR THEIR IMPLANTED DEVICES WITH TECHNICAL INFO FOR PTS TO SHOW RADIOLOGISTS AND PHYSICIANS FOR SAFETY CONCERNS DURING MRA EXAMS AND TSA AGENTS AT AIRPORTS AS SOME DEVICES TRIGGER ALARMS. I HAVE NEVER RECEIVED A CARD FOR THE CERTAS-CODMAN VALVE, SO I CALLED J&J ONLY TO FIND OUT, THE UNIT WAS SOLD TO INTEGRA LIFE SCIENCES. I CALLED INTEGRA BUT HAVE NOT HEARD BACK FROM INTEGRA MEDICAL INQUIRY DIVISION. MY COMPLAINT IS WITH J&J AND INTEGRA LIFE SCIENCES FOR FAILING TO PROVIDE IMPLANTED DEVICE ID CARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923291 CERTAS CODMAN SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG JOHNSON & JOHNSON / INTEGRA LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR