BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS DR

    MDR report key: 3210714 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03537
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 16, 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 FIELD EVENT OF AN OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. AN ARC MARK WAS OBSERVED ON THE ICD CAN. FURTHER EVALUATION OF THE ARC MARK INDICATED THE PRESENCE OF LEAD MATERIAL. THE DAMAGE FOUND IS CONSISTENT WITH THAT CAUSED BY ARCING BETWEEN THE HV CONDUCTOR AND THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAN AN OUTPUT CIRCUIT FAILURE MESSAGE WAS DISPLAYED WHEN ATTEMPTING TO DELIVER A SECOND SHOCK, AFTER THE FIRST SHOCK WAS PURPOSELY DELIVERED IN THE HOSPITAL. THE DEVICE WAS REPLACED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310806 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)