BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 2984326 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00592
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 11, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 IN THE LABORATORY. SEVERAL ARC MARKS WERE 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. THE LOW VOLTAGE FUNCTIONALITY WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST AND DID NOT RECEIVE THERAPY FROM THE DEVICE. THE PATIENT HAD BE EXTERNALLY RESCUED. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE WITH NO DEFIBRILLATION CAPABILITIES. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87797 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR (B)(4)