BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3881109 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02248
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 29, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT THAT A DEVICE EXHIBITED FAR FIELD R WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31211 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD CD3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention