BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1895852 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04787
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 4, 2010
    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.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED IN THE LABORATORY. BASED ON PROGRAMMED SETTINGS AND USAGE DATA, A LONGEVITY CALCULATION WAS PERFORMED AND THE BATTERY WAS WITHIN NORMAL LONGEVITY ESTIMATIONS. DEVICE FUNCTION WAS NORMAL WHEN TESTED ON THE BENCH.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED THAT THE DEVICE WAS EXPLANTED DUE TO ERI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LONGEVITY CALCULATION ESTIMATED THE DEVICE HAD 5 TO 8 MONTHS BEFORE REACHING ERI. ON (B)(6) 2010 A LONGEVITY ESTIMATION SHOWED THE DEVICE HAD 25-28 MONTHS UNTIL ERI. THE PHYSICIAN NO LONGER HAS ACCESS TO THE PATIENT OR RECORDS. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 57 YR Required Intervention