BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS DR

    MDR report key: 3890209 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04496
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 14, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED POST SENSED T WAVE OVERSENSING WAS OBSERVED. PATIENT RECEIVED INAPPROPRIATE HV THERAPY. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34438 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD V-242

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention