BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 4153479 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16397
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE HV THERAPY FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. PROGRAMMING CHANGES WERE PLANNED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630458 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR