BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF4 CONNECTOR

    MDR report key: 2984402 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00548
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 24, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYIS. THE REPORTED THRESHOLD ANOMALY COULD NOT BE REPRODUCED IN THE LABORATORY. DURING ANALYSIS, HIGH CURRENT LEAKAGE WAS WAS DETECTED. FURTHER EVALUATION IDENTIFIED DAMAGE WITHIN THE HIGH VOLTAGE CIRCUITRY.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89066 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