BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA XT VR

    MDR report key: 3863112 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10978
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 LIA (LEAD INTEGRITY ALERT) TRIGGERED DUE TO NON-PHYSIOLOGIC SENSING, WITH SEVERAL NST (NON-SUSTAINED TACHYCARDIA) EPISODES OCCURRING DURING A SHORT PERIOD OF TIME COINCIDENT WITH CARDIAC BYPASS SURGERY. THE DEVICE WAS LATER INTERROGATED BY THE CLINICIAN AND NO EVIDENCE OF A LEAD ISSUE WAS FOUND. 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
    339460 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DVBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR 694765 LEAD