BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 22805572 · Received August 14, 2025

    Report

    Report Number
    2649622-2025-22104
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    DTB
    UDI-DI
    00643169633742
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B3. DATE OF EVENT: CORRECTED FROM 2025-07-19 TO 2025-07-18 G3. DATE MFR REC: CORRECTED FROM 2025-07-21 TO 2025-07-18. PLEASE NOTE THAT THE INITIAL MFR REPORT NUMBER: 2649622-2025-22104 SUBMITTED 2025-08-14 INADVERTENTLY HAD THE INCORRECT DATE AND IS NOW BEING CORRECTED ACCORDINGLY. THE DATE 2025-07-18 SHOULD HAVE BEEN USED IN SECTION G3 ON THE INITIAL REPORT. THE AWARE DATE 2025-08-20 BEING USED IN THIS CORRECTION SUPPLEMENTAL REPORT, IS THE DATE WHEN THE ERROR WAS IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 5076-52 LEAD; IMPLANT DATE (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 BY THE PATIENT THAT AFTER A DEVICE CHANGEOUT PROCEDURE, THEY FELT PULSATING AT THE BOTTOM OF THEIR RIBCAGE WHEN THEY WERE STILL IN THE OPERATING ROOM (OR), BUT IT SEEMED LIKE IT WENT AWAY. THE PATIENT WENT HOME AND FELT THE PULSATION AGAIN WHEN THEY LAY ON THEIR RIGHT SIDE ONLY. THE PATIENT RECEIVED A CALL FROM THE HOSPITAL AND WAS TOLD THERE HAS BEEN A SHIFT IN THE RIGHT ATRIAL (RA) LEAD AND NEEDED TO DO ANOTHER X-RAY. 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
    1556576 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC PUERTO RICO VILLALBA 5076-45 00643169633742

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female W4TR01 CRT-P, 479878 LEAD