BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE QUADRA CRT-D, DF-4, CONNECTOR

    MDR report key: 3890402 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03561
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    February 15, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP VT EPISODES WITH VENTRICULAR CROSS-TALK WERE NOTED TO HAVE CAUSED AN INAPPROPRIATE SHOCK. THIS WAS CLINICALLY RESOLVED BY REPROGRAMMING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30722 PROMOTE QUADRA CRT-D, DF-4, CONNECTOR NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3239-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention