BEUDAMED
    FDA Adverse Event Summary report: N

    ATLAS PLUS VR

    MDR report key: 3812029 · Received May 15, 2014

    Report

    Report Number
    2938836-2014-03757
    Date Received
    May 15, 2014
    Date of Event
    October 18, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED POST PACED T WAVE OVERSENSING WAS OBSERVED. PATIENT DID NOT RECEIVE THERAPY. DECREASE VENTRICULAR SENSITIVITY WAS RECOMMENDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP. POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289929 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-193

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR