BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 19499560 · Received June 10, 2024

    Report

    Report Number
    2649622-2024-15362
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 10, 2024
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    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 CHEST DISCOMFORT APPROXIMATELY FIVE DAYS POST IMPLANT. INTRACARDIAC ELECTROCARDIOGRAM (ECG) SHOWED THAT THE PACEMAKER TIMING CYCLE WAS RESET BY TWOS AFTER VENTRICULAR PACING AND CAUSED PROLONGATION OF THE RR INTERVAL. 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
    148717 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention W2DR01 IPG, 5076-52 LEAD