BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 5453902 · Received February 23, 2016

    Report

    Report Number
    2938836-2016-01285
    Event Type
    Injury
    Date Received
    February 23, 2016
    Date of Event
    January 31, 2016
    Report Date
    January 31, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED BACKUP DFO WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND NO ANOMALY WAS FOUND. THE ROOT CAUSE OF THE BACKUP DFO COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASYMPTOMATIC PATIENT PRESENTED IN THE ER WITH DEVICE IN BACKUP VVI RESET MODE. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY AND THE DEVICE WAS RESTORED TO NORMAL OPERATION. THE FOLLOWING DAY, THE RESET RECURRED AGAIN. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109695 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2411-36Q A000013861

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention