BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT DR

    MDR report key: 4161776 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02256
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    August 27, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CLASSIFIED AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) AS SINUS TACHYCARDIA. THE TACHYCARDIA SELF-TERMINATED. THE DOCTOR NOW WANTED TO UNDERSTAND THE ALGORITHM AND PROGRAMMING RECOMMENDATIONS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639408 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND DDBB2D4

    Patients

    Seq Age Sex Outcome Treatment
    1