BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 4160792 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01875
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 13, 2012
    Manufacturer
    ST. JUDE MEDICAL INC. CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE DELIVERED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE DEVICE ORIGINALLY DIAGNOSED THE RATE AS SVT AND SUDDEN ONSET DETERMINING VT. THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26827 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC. CRMD CD3249-40

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention