BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR ICD, US

    MDR report key: 5049320 · Received September 2, 2015

    Report

    Report Number
    3010215456-2015-28614
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED OVERSENSING EPISODES WAS OBSERVED. THE PHYSICIAN ELECTED TO MAKE ANY PROGRAMMING CHANGES FIR THE MOMENT. THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582327 ELLIPSE VR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. (CRM-KISTA) CD1377-36C S000002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention