BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 3101136 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01941
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 A DAY AFTER IMPLANT, THE PATIENT WAS IN A PERSISTENT STATE OF AF. THE DEVICE WAS UNABLE TO SENSE AF AND ISSUE WAS RESOLVED BY CHANGING THE SENSING/PACING VECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202852 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention