BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA¿ XT CRT-D

    MDR report key: 10168164 · Received June 18, 2020

    Report

    Report Number
    3004209178-2020-10591
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 26, 2018
    Report Date
    June 18, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169007246
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT FOR EPISODES OF T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD ALSO EXHIBITED SMALL R-WAVES. THE RV SENSITIVITY SETTINGS WERE RE-PROGRAMMED. IT WAS ALSO NOTED THAT THERE WERE EPISODES OF OVERSENSING FROM ELECTROMAGNETIC INTERFERENCE (EMI) DUE TO THE PATIENT'S USE OF A LEAF BLOWER. THE RV LEAD AND CRT-D REMAIN 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
    631262 VIVA¿ XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D1 00643169007246

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR