BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA¿ QUAD XT CRT-D

    MDR report key: 23256897 · Received October 9, 2025

    Report

    Report Number
    3004209178-2025-17104
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    February 12, 2021
    Report Date
    October 9, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0180 LEAD IMPLANTED: (B)(6) 2011. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DATA TRANSMITTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE ICD REMAINS 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
    2481238 VIVA¿ QUAD XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1Q1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Life Threatening 459878 LEAD, 407652 LEAD