BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3890435 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03535
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 18, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR CAPTURE THRESHOLD VARIED BETWEEN THE DEVICE AND THE EXTERNAL PACING SYSTEM ANALYZER. THE DEVICE WAS EXPLANTED, RETURNED, AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31046 UNIFY CRT-D, DF-4 CONNECTOR NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention