BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1831054 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03636
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 23, 2010
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMMUNICATION ANOMALY WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, THE DEVICE LONGEVITY WAS FOUND TO BE OUTSIDE OF THE EXPECTED LIMITS. THE BATTERY WAS REMOVED AND THE DEVICE WAS ANALYZED WITH A POWER SUPPLY AND FOUND TO BE NORMAL. THE ORIGINAL BATTERY WAS SENT OUT TO THE VENDOR FOR FURTHER EVALUATION, AND NO ANOMALY WAS DETECTED THAT WOULD CAUSE THE BATTERY TO DEPLETE. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE ICD WAS SUSPECTED TO BE AT END OF LIFE PREMATURELY. HENCE, THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention