BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 19499660 · Received June 10, 2024

    Report

    Report Number
    3008973940-2024-04211
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 10, 2024
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    UDI-DI
    00681490124812
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: T-WAVE OVERSENSING AFTER IMPLANTATION OF PACEMAKERS WITH AUTOMATIC SENSITIVITY ADJUSTMENT IN PATIENTS WITH ATRIOVENTRICULAR BLOCK. PACING AND CLINICAL ELECTROPHYSIOLOGY. 2024; 47:561¿563. DOI: 10.1111/PACE.14773. 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 T-WAVE OVERSENSING (TWOS) AFTER PACEMAKER IMPLANTATION. THE AUTHORS DESCRIBED A PATIENT WHO EXPERIENCED SLIGHT PALPITATIONS APPROXIMATELY FIVE DAYS POST IMPLANT. INTRACARDIAC ELECTROCARDIOGRAM (ECG) SHOWED THE PACED QRS FALLING OFF WHEN THE PATIENT GOT UP TO GO TO THE BATHROOM WHICH WAS CAUSED BY TWOS. THE LEAD WAS REPROGRAMMED, AND THIS RESOLVED THE TWOS. THE LEAD REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659464 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC SINGAPORE OPERATIONS 5076-52 00681490124812

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention A3DR01 IPG, 5076-45 LEAD