BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT VR

    MDR report key: 3990043 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-14487
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTING HEARING THE DEVICE ALERT WHILE USING SOLDERING IRON AT WORK. THE PATIENT ALSO REPORTS THAT THERE IS A MAGNIFYING GLASS WITH FLORESCENT LIGHT FIXTURES NEAR THE ICD. THE ALERT TONES WERE CONSISTENT WITH MAGNET EXPOSURE. 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
    465110 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR 6935M-55 LEAD