BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 3880477 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03489
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 6, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE REPORTED FIELD EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED AFTER PERFORMING LONGEVITY CALCULATIONS. DIFFERENT TESTS WERE PERFORMED AND NO SOURCES OF HIGH CURRENT WERE FOUND. THE BATTERY WAS SENT TO ITS MANUFACTURER FOR ANALYSIS, WHERE AN INTERNAL SHORT WAS FOUND. THE CAUSE OF THE PREMATURE DEPLETION IS BELIEVED TO BE DUE TO THIS INTERNAL BATTERY SHORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS BEEN DEPLETED RAPIDLY AND THERE APPEARS TO BE NO REASON FOR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28118 ATLAS PLUS HF CRT-D NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention