BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 2984422 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00607
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 29, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND RV LEAD WERE REPLACED DUE TO HV IMPEDANCE ISSUE. REVIEW OF THE SESSION RECORD SHOWED AN ALERT FOR OUTPUT CIRCUIT DAMAGE AND LOW HV LEAD IMPEDANCE. THERAPY WAS DELIVERED INAPPROPRIATELY FOR SVT. AFTER THE INITIAL SHOCK, NOISE WAS SEEN ON THE P/S PORTION OF THE LEAD. DEVICE CONTINUED TO ATTEMPT TO DELIVER THERAPY BUT WAS ABORTED MULTIPLE TIMES DUE TO POSSIBLE HV CIRCUIT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87850 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male (B)(4)| (B)(4)