BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY QUADRA CRT-D, DF-4 CONNECTOR

    MDR report key: 3880718 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03366
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 30, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    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

    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

    NEW INFORMATION RECEIVED INDICATED THAT POST-PACED T-WAVE OVERSENSING CONTINUE TO BE SEEN VIA REVIEW OF MERLIN TRANSMISSION. PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DEVICE THAT WAS POSED PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. IT WAS RECOMMENDED TO REPROGRAM THE DEVICE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24334 UNIFY QUADRA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD CD3249-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR