BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 2905268 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00612
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 26, 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
    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 WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE OBSERVED. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND AN INTERNAL BATTERY ANOMALY WAS FOUND THAT CAUSED THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10917 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 84 YR Required Intervention