BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 3872951 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11868
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 28, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERSENSING WAS OBSERVED DURING DEFIBRILLATION THRESHOLD TESTING. HIGH VOLTAGE THERAPY WAS DELIVERED AND A "RETURN TO SINUS" WAS PROPERLY DETECTED DESPITE THE UNDERSENSING. NO PATIENT SYMPTOMS WERE REPORTED. PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350042 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR