BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA¿ XT CRT-D

    MDR report key: 8701110 · Received June 14, 2019

    Report

    Report Number
    9614453-2019-01947
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    UDI-DI
    00763000059668
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 A POSSIBLE INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS FAST VENTRICULAR TACHYCARDIA (VT). THERE WAS A HIGH THRESHOLD ALERT ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494933 VIVA¿ XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTBA1D4 00763000059668

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening 5568-53 LEAD, 6947M62 LEAD, 511211 LEAD