BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 4170191 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02876
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    April 6, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. THE REPORTED FIELD EVENT OF DEVICE RESET WAS CONFIRMED. THE CAUSE OF THE RESET WAS FOUND TO BE DUE TO A POWER-ON RESET. THE DEVICE WAS TESTED ON THE BENCH AND ALL TEST SPECIFICATIONS ARE NORMAL. IT IS BELIEVED THE ROOT CAUSE OF THE FIELD EVENT IS DUE TO A LEAD ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED IN THE ER AFTER BEING SHOCKED APPROPRIATELY FOR A VENTRICULAR ARRHYTHMIA. INTERROGATION OF THE DEVICE STATED POSSIBLE OUTPUT CIRCUIT DAMAGE. THE DEVICE WAS FOUND TO BE IN HIGH VOLTAGE VVI AND EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23745 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL INC. CRMD V-340

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention (B)(4)| (B)(4)| (B)(4)