BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3903713 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12740
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO AN EXCESSIVE NUMBER OF RESETS. THE RESETS WERE REPRODUCED DURING TEMPERATURE CHAMBER TESTING. THE DEVICE TESTED NORMALLY AT ROOM TEMPERATURE AND WARMER TEMPERATURES. THE CAUSE OF THE RESETS WAS AN ANOMALOUS COMPONENT ON THE HYBRID THAT WAS SENSITIVE TO EXTREME TEMPERATURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, BEFORE IMPLANT THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381233 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2377-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1