BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR, DF4 CONNECTOR

    MDR report key: 3101185 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01965
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 9, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INAPPROPRIATE THERAPY DUE TO AN SVT THAT FELL IN A VF ZONE WAS OBSERVED. THE PATIENT WAS NOT SYMPTOMATIC. THE DEVICE INTERMITTENTLY BINNED EVENTS IN THE VF ZONE. PROGRAMMING CHANGES WERE MADE AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203607 ELLIPSE DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention