BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1895870 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04785
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 25, 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
    SC
    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 NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A LOW BATTERY VOLTAGE. NO HIGH CURRENT DRAIN SOURCES WERE FOUND ON THE HYBRID DURING BENCH, AUTOMATED ELECTRICAL, TEMPERATURE, AND HUMIDITY TESTING. THE BATTERY WAS SENT TO THE VENDOR AND NORMAL DEPLETION CHARACTERISTICS WERE FOUND. IT IS BELIEVED THAT THE LOSS OF COMMUNICATION WAS DUE TO NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED FEELING SYMPTOMATIC. THE DEVICE WAS UNABLE TO INTERROGATE. PACING SPIKES WERE OBSERVED ON THE LAST PATIENTS VISIT TO THE CLINIC. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-343 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention