BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 2902632 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00445
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    January 24, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED NO INTERROGATION WAS CONFIRMED IN THE LAB. A LONGEVITY CALCULATION WAS PERFORMED AND THE DEVICE WAS FOUND TO MEET ITS OVERALL LONGEVITY REQUIREMENT. HOWEVER, THE REVIEW OF THE BATTERY DEPLETION PROFILE SHOWED A SHARP DROP IN BATTERY VOLTAGE. WITH THE REMOVAL OF THE BATTERY AND AN EXTERNAL POWER SUPPLY CONNECTED, THE DEVICE TESTED NORMAL. THE BATTERY WAS SENT TO THE MANUFACTURER BUT NO ANOMALIES WERE FOUND. THE CAUSE OF THE NO INTERROGATION AND SHARP DROP IN BATTERY VOLTAGE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR FOLLOW-UP. DEVICE COULD NOT BE INTERROGATED. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9266 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR