BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 3220088 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04666
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 30, 2013
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR AN UNSPECIFIED REASON. IT WAS NOTED, THE PATIENT WAS WALKING AND HAD TO SIT, AND THEN BECAME UNCONSCIOUS. IT WAS REVEALED, THE PATIENT WAS IN VENTRICULAR TACHYCARDIA AND THE DEVICE DID NOT DELIVER THERAPY. UPON DEVICE INTERROGATION, IT WAS FOUND THAT THE DEVICE WAS PROGRAMMED AT HIGHER RATE THAN THE VT OCCURRED AND THEREFORE THE VT WAS NOT TREATED. DEVICE WAS REPROGRAMMED AND PATIENT'S MEDICATION WAS ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319642 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention