BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 24627758 · Received March 18, 2026

    Report

    Report Number
    2649622-2026-07620
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    DTB
    UDI-DI
    00643169708198
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 1581 LEAD IMPLANTED: (B)(6) 2007 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 THE PATIENT EXPERIENCED CHEST PAIN. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS IN PROGRESS AND UNNECESSARY PACING AT TIMES. THE RA LEAD 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
    692231 CAPSUREFIX NOVUS MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC PUERTO RICO VILLALBA 407652 00643169708198

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male 4798 LEAD, DTPA2Q1 CRT-D