BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 4021814 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14558
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED INTO CLINIC AFTER RECEIVING A NOTIFIER ALERT. REVIEW OF EGMS SHOWED INTERMITTENT VENTRICULAR UNDERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499050 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR