BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 3080196 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01029
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 28, 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 Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW EXPECTED LIMITS. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ANNUAL FOLLOW UP, THE DEVICE WAS FOUND TO BE BELOW END OF LIFE. REVIEW OF SESSION RECORDS REVEALED THAT ONE MONTH PRIOR THE BATTERY WAS FOUND TO BE WITHIN NORMAL RANGE. PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182221 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention