BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF4 CONNECTOR

    MDR report key: 3101171 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01970
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 1, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING AN ALERT FOR HIGH HV LEAD IMPEDANCE. THE PHYSICIAN SUSPECTS THE DEVICE HAD PULLED DOWN AND MIGRATED DUE TO EXCESSIVE CHEST TISSUE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202830 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 54 YR (B)(4)