BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1954680 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00548
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    June 22, 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 Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO DELAY IN RECEIVING PAPERWORK. UPON INTERROGATION, NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE DUE TO A DEPLETED BATTERY. THE DEVICE WAS ANALYZED WITH A POWER SUPPLY AND WAS FOUND TO BE NORMAL. THE 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 WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION TO EOL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention