BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC VR

    MDR report key: 4170187 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02882
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    May 28, 2012
    Manufacturer
    ST JUDE MED INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN RETRIEVED SEVERAL EPISODES CLASSIFIED AS SVT/VT/VF EPISODES AND TREATED BY ATP AND SHOCK. THE PHYSICIAN THINKS THAT THE EPISODES WERE ACTUALLY ATRIAL FIBRILLATION. AN EPISODE OF VENTRICULAR INTERFERENCE WAS RETRIEVED. THE PHYSICIAN DECIDED NOT TO TAKE ANY ACTION, HOWEVER, THE DEVICE WILL BE REPLACED SOON DUE TO LOW BATTERY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23728 EPIC VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MED INC., CRMD V-197

    Patients

    Seq Age Sex Outcome Treatment
    1