BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 3882090 · Received June 18, 2014

    Report

    Report Number
    2938836-2014-04427
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    September 28, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY. NO COMMUNICATION COULD BE ESTABLISHED DURING BENCH TESTING. THE DEVICE WAS TESTED USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE REPORTED NO COMMUNICATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    NEW INFORMATION AVAILABLE STATES THE DEVICE WAS EXPLANTED AND RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358565 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD V-343

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention