BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 25247079 · Received May 21, 2026

    Report

    Report Number
    2649622-2026-15115
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    DTB
    UDI-DI
    00643169708204
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: UNKNOWN IMPULSE DYNAMIC DEVICE IMPLANTED ON (B)(6) 2023; 6725 ADAPTOR IMPLANTED ON (B)(6) 2023; 407658 LEAD IMPLANTED ON (B)(6) 2023. 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 WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC CONTRACTILITY MODULATION THERAPY DEVELOPED TRICUSPID REGURGITATION OVER TIME. THE THREE RIGHT VENTRICULAR (RV) LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411840 CAPSUREFIX NOVUS MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC PUERTO RICO VILLALBA 407658 00643169708204

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| R DDMB1D4 ICD, 5076-52 LEAD, 6935M62 LEAD.