BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1895854 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04792
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 30, 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
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS VERIFIED IN THE LABORATORY. A LONGEVITY CALCULATION WAS PERFORMED BASED ON THE DEFAULT PARAMETER SETTINGS. THE LONGEVITY WAS FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED SYSTEM. NO HIGH CURRENT MEASUREMENTS WERE FOUND. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. NO ANOMALIES WERE FOUND THAT WOULD CAUSE BATTERY DEPLETION. THE CAUSE OF THE PREMATURE BATTERY DEPLETION REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWED AN ALERT FOR ERI. REVIEW OF BATTERY MEASUREMENTS SHOWED EXCESSIVE BATTERY DISCHARGE. THE PATIENT HAD NOT RECEIVED ANY HV THERAPY IN THE LAST 30 DAYS. THE DEVICE WAS EXPLANTED.

    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 70 YR Required Intervention