BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 3884715 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12126
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 15, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT POST-PACED T-WAVE OVERSENSING RECURRED. THE PATIENT WAS ASYMPTOMATIC. FURTHER PROGRAMMING CHANGES WERE MADE AND THE DEVICE REMAINS IMPLANTED. REMOTE MONITORING WILL CONTINUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP AND POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360603 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR