BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 3090029 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01270
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 12, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED OUTPUT ANOMALY WAS CONFIRMED. AN ARC MARK WAS FOUND ON THE DEVICE CAN AND LEAD MATERIAL WAS PRESENT IN THE ARC. THE CAUSE OF THE ANOMALY WAS FOUND TO BE DUE TO A LEAD ANOMALY.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED IN CLINIC, LOW SHOCK LEAD IMPEDANCE WAS OBSERVED BEFORE THE PC SHOCK. SUSPECTED THAT THE ICD MAY BE DAMAGED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191698 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 1582/65 (B)(4)