BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 25257250 · Received May 22, 2026

    Report

    Report Number
    2182208-2026-29596
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    January 1, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/72 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TANDEM APPROACH FOR TRANSVENOUS LEAD EXTRACTION: EFFICACY, SAFETY, AND OPERATIONAL LEARNING CURVE. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2026. 37:282¿295. DOI: 10.1111/JCE.70207. 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

    LITERATURE WAS REVIEWED REGARDING A TANDEM APPROACH FOR TRANSVENOUS LEAD EXTRACTION (TLE). THE AUTHORS DESCRIBED LEADS WHICH WERE EXTRACTED DUE TO HIGH THRESHOLDS, HIGH IMPEDANCE, AND NOISE AND OVERSENSING. THERE WAS ONE LEAD WHICH COULD NOT BE EXTRACTED DUE TO EXTENSIVE ADHESIONS AND SUPERIOR VENA CAVA (SVC) OCCLUSION. THERE WERE MAJOR COMPLICATIONS RELATED TO TLE WHICH INCLUDED TWO CASES OF PROCEDURAL VENTRICULAR FIBRILLATION (VF) DUE TO MECHANICAL IRRITATION OF THE RIGHT VENTRICLE DURING EXTRACTION OR REIMPLANTATION, BOTH SUCCESSFULLY TERMINATED WITH DEFIBRILLATION. MINOR COMPLICATIONS INCLUDED POCKET HEMATOMAS WHICH REQUIRED EVACUATION, WORSENING TRICUSPID REGURGITATION, TEMPORARY ASYSTOLE, PERICARDIAL EFFUSION, DAMAGE TO OTHER LEADS, AND ONE HYPERTENSIVE CRISIS. THE STATUS OF THE DEVICES AND LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611854 CAPSURE SP NOVUS LEAD PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 5092

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H UNKNOWN COMPETITOR CIED