BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 8685655 · Received June 10, 2019

    Report

    Report Number
    2938836-2019-04647
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 10, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    UDI-DI
    05414734507738
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING VIBRATORY PATIENT NOTIFICATION ALERT, AN ALERT FOR EXTENDED CHARGE TIME WAS OBSERVED. PATIENT WAS NOTED TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND HAD A VF EPISODE WITH SEVERAL CHARGES. DEVICE WAS INTERROGATED AGAIN IN A DAY AND NORMAL CHARGE TIME WAS NOTED. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476008 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1411-36Q S000045925 05414734507738

    Patients

    Seq Age Sex Outcome Treatment
    1