BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 22858399 · Received August 21, 2025

    Report

    Report Number
    2649622-2025-22784
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 21, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    NVN
    UDI-DI
    00763000740269
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 THAT DURING THE PROCEDURE THAT PATIENT EXPERIENCED ASYSTOLE AND CRACKED RIBS DURING CARDIOPULMONARY RESUSCITATION (CPR). IT WAS FURTHER NOTED THAT DURING THE AVJ ABLATION, AFTER THE AV NODE WAS BURNED, THE PATIENT WENT ASYSTOLIC AS THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED NON CAPTURE, DESPITE THE CATHETER NOT BEING IN CONTACT WITH THE LEAD. THE LBB LEAD IS BELIEVED TO HAVE STOPPED CAPTURING BECAUSE THE LESION REACHED AND DAMAGED THE TISSUE WHERE THE LEAD WAS IN CONTACT. IT WAS FURTHER NOTED THAT THE LBB LEAD EXHIBITED RISING THRESHOLDS. THE LBB WAS REPOSITIONED, REPROGRAMMED AND 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
    408419 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC PUERTO RICO VILLALBA 383069 00763000740269

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| R| L 5076-52 LEAD, W1DR01 IPG