BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY QUADRA CRT-D, DF-4 CONNECTOR

    MDR report key: 4092046 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05096
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 13, 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

    ALL INFORMATION 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. E3: COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PRESENTED IN BACKUP VVI AND POWER ON RESET DURING DFT TESTING AT IMPLANT. AN INDUCED VENTRICULAR FIBRILLATION WAS EXTERNALLY DEFIBRILLATED AND CAUSED THE DEVICE TO REVERT TO VVI. THE DEVICE WAS REPROGRAMMED. THE PHYSICIAN THEN PERFORMED A SUCCESSFUL DFT TESTING AND CLOSED THE POCKET. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23222 UNIFY QUADRA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DIFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CRMD CD3249-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR