BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 2902591 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00456
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 14, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BACKUP RESET WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET. THE CAUSE OF THE POWER ON RESET WAS A LOW BATTERY VOLTAGE. DEVICE DIAGNOSTICS SHOWED THAT THE BATTERY DEPLETION WAS NORMAL BASED ON DEVICE USAGE. THE DEVICE REMAINED IMPLANTED AFTER END OF SERVICE AND CYCLIC CHARGING OCCURED WHICH EVENTUALLY CAUSED A POWER ON RESET. DURING TESTING, A NEW BATTERY WAS ATTACHED AND THE DEVICE WAS FOUND TO FUNCTION NORMALLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR THE FIRST TIME SINCE IMPLANT. UPON INTERROGATION, THE DEVICE WAS FOUND IN HW RESET. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8513 ATLAS II HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR