BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA S VR

    MDR report key: 3992994 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01933
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INAPPROPRIATE DEVICE ALERT FOR EPISODES OF NONSUSTAINED VENTRICULAR TACHYCARDIA RESULTING IN REPROGRAMMING OF THE DEVICE BY PROLONGING THE NUMBER OF INTERVALS TO DETECT/REDETECT (NID). A COMPARISON OF THE USE BEFORE DATE FIELD AND IMPLANT DATE FOUND THE RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED AFTER THE USE BEFORE DATE. THE DEVICE AND RV LEAD REMAIN IN USE. THE PATIENT WAS REPORTED TO BE ENROLLED IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467462 EVERA S VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND DVBC3D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR 6947M55 LEAD