BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 4170202 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02877
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    September 22, 2011
    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
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF INAPPROPRIATE HV THERAPY WAS VERIFIED AFTER REVIEW OF THE STORED ELECTROGRAMS. THE SEGM REVEALED T-WAVE OVERSENSING. THE CAUSE OF THE INAPPROPRIATE THERAPY WAS NOISE AND THE CAUSE OF THE NOISE WAS FOUND TO BE T-WAVE OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED FOR ISSUES REGARDING INAPPROPRIATE THERAPY. THE DEVICE WAS AT ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23744 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC. CRMD V-340

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention