BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF

    MDR report key: 4170122 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02906
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 2, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION: THE REPORTED FIELD EVENT OF NO PACING WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF STORED ELECTROGRAMS IN THE LABORATORY. THE REPORTED FILED EVENT OF COMMUNICATION NONE WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND OUR AUTOMATED TESTING EQUIPMENT. ANALYSIS FOUND INTERNAL DAMAGE BETWEEN THE ANODE AND CATHODE SEPARATORS, CAUSING AN INTERNAL SHORT OF THE BATTERY. THIS DAMAGE RESULTED IN PREMATURE DEPLETION OF THE BATTERY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC DUE TO DECOMPENSATION. THE DEVICE WAS UNABLE TO INTERROGATE. THE EGM SHOWED NO BIVENTRICULAR STIMULATION. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23720 ATLAS II PLUS HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC., CRMD V-367

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7071/65, (B)(4)