BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 21650353 · Received March 20, 2025

    Report

    Report Number
    2649622-2025-07729
    Event Type
    Death
    Date Received
    March 20, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 28, 2025
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633759
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 3387-40 DBS LEAD, 3387-40 DBS LEAD, 748251 NEURO EXTENSION, 748251 NEURO EXTENSION WAS IMPLANTED ON (B)(6) 2003.  64001 NEURO ADAPTOR, 37612 DBS IPG WAS IMPLANTED ON ( B)(6) -2016.  5076-58 LEAD WAS IMPLANTED ON (B)(6) -2019.  37602 DBS IPG WAS IMPLANTED ON (B)(6) -2021.  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

    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 RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES AND RESULTING IN FALSE TERMINATION OF AT/AF DETECTION. THE LEAD REMAINS IN PATIENT. IT WAS ALSO NOTED THAT THE PATIENT PASSED AWAY APPROXIMATELY TWO WEEKS AFTER THE REMOTE TRANSMISSION.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT'S DEATH WAS NOT LINKED TO THE PERFORMANCE OF THE RA LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508217 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 5076-52 00643169633759

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death 459888 LEAD, W4TR01 CRT-P,