BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 3220051 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04700
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 7, 2013
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTING TO THE CLINIC FOR NORMAL FOLLOW-UP. UPON INTERROGATION, THE DEVICE REPORTED THAT IT HAD REACHED EOL. SUSPECTED PREMATURE BATTERY DEPLETION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS EXPLANTED THE NEXT DAY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320431 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-366 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention