BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3891216 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03531
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 20, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL: THE REPORTED FIELD EVENT OF RF TELEMETRY ANOMALY WAS CONFIRMED VIA REVIEW OF THE DEVICE IMAGE IN THE LABORATORY. ANALYSIS FOUND THAT THE CAUSE OF THE ANOMALY WAS A FIRMWARE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REP COULD NOT COMPLETELY INTERROGATE THE DEVICE. PRODUCT WILL BE RETURNED AND WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31196 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1