BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1831047 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03640
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 21, 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED VIA REVIEW OF ARCHIVED DATA RECEIVED FROM THE FIELD. NO SOURCES OF HIGH CURRENT DRAIN WERE FOUND THROUGHOUT DEVICE TESTING. THE BATTERY WAS SENT TO THE VENDOR FOR DESTRUCTIVE ANALYSIS. NO ANOMALIES WERE DETECTED THAT WOULD CAUSE THE BATTERY TO DEPLETE PREMATURELY. THE CAUSE FOR THE PREMATURE BATTERY DEPLETION REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    THE LEAD WAS CAPPED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION.

    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 Required Intervention 1570/65, (B)(4)