BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 3160393 · Received June 10, 2013

    Report

    Report Number
    9614453-2013-01420
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    April 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME/SIMILAR 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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECORDED EPISODES WHICH FROM THE ELECTROCARDIOGRAM (EGM) APPEARED TO BE TRIGGERED BECAUSE OF NOISE. THE NOISE WAS SEEN IN BOTH THE ATRIAL AND VENTRICULAR EGMS SUGGESTIVE OF EXTERNAL INTERFERENCE. IT WAS NOTED THAT THE EPISODES STOPPED AND NO THERAPIES WERE DELIVERED. 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
    260165 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR