BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 2984522 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00610
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 14, 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
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER UPON RECEIPT. LOW BATTERY VOLTAGE WAS OBSERVED. WITH ANOTHER BATTERY ATTACHED, THE DEVICE FUNCTIONED NORMALLY; NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE WITH THE EXPECTED LIMITS. HOWEVER, RAPID DEPLETION FROM ERI TO EOS WAS OBSERVED. THE DEVICE FUNCTION WAS NORMAL WHEN TESTED ON THE BENCH. THEREFORE, THE RAPID DEPLETION FROM ERI TO EOS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO VISIT AND ERI INDICATOR WAS OBSERVED. THE DEVICE WAS UNABLE TO BE INTERROGATED AND NO PACING WAS NOTED. PREMATURE BATTERY DEPLETION SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89030 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 75 YR