BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3891169 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03581
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION: THE REPORTED FIELD EVENT OF COMMUNICATION ANOMALY WAS CONFIRMED INT HE LAB. ANALYSIS FOUND THAT THE CAUSE OF THE ANOMALY WAS A KNOWN FIRMWARE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED IN THE BOX. PRODUCT WAS RETURNED AND WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28180 FORTIFY VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, LWS LWS ST. JUDE MEDICAL, INC., CRMD CD1231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1