BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA¿ XT CRT-D

    MDR report key: 22978557 · Received September 5, 2025

    Report

    Report Number
    2182208-2025-04444
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. THERE WAS NO PATIENT INVOLVEMENT. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: IMPACT OF TABLET-INDUCED ELECTROMAGNETIC INTERFERENCE ON ABDOMINAL CARDIAC DEVICES: A STUDY BASED ON SIMULATED P ATIENTS. JOURNAL OF ARRHYTHMIA. 2025; 41:E70136. DOI: 10.1002/JOA3.70136 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

    LITERATURE WAS REVIEWED REGARDING ELECTROMAGNETIC INTERFERENCE (EMI) ON ABDOMINAL CARDIAC DEVICES. THE AUTHORS DESCRIBED SIMULATED PATIENTS WHO WERE INTERROGATED AFTER AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TAPED TO THEIR ABDOMEN AND OPERATED AN ELECTRONIC COMPUTER TABLET FOR TEN MINUTES TO TRY TO INDUCE EMI. EMI OCCURRED IN SOME OF THE ICDS WITH VARIOUS DISTANCES. THE STATUS OF THE DEVICES IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225836 VIVA¿ XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown