BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR ICD

    MDR report key: 5930901 · Received September 6, 2016

    Report

    Report Number
    2938836-2016-06997
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    June 23, 2016
    Report Date
    June 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHEST PAIN. COMPETITIVE ATRIAL PACING CAUSED BY LONG PVARP AND LONG PAV DELAY WAS OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582860 ELLIPSE DR ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2411-36C 4293533

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR