CapSureFix Novus Lead MRI SureScan

Description of Event or Problem

Literature was reviewed regarding left bundle branch area pacing (LBBAP) versus right ventricular pacing (RVP). The authors described patient deaths; however, the causes of death were unknown and categorized as all-cause or one-year mortality. It was noted that none of the deaths were due to implant-related causes. There were patients who experienced procedure-related complications in the LBBAP and RVP groups which included implant-related deep venous thrombosis, infection, perforation which required revision, pericardial effusion which required pericardiocentesis, pneumothorax, pocket hematoma, stroke, and heart failure hospitalizations. Leads exhibited dislodgements and unknown failures. The status of the devices and leads is unknown. No additional adverse patient effects or product performance issues were reported.

Additional Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. 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/73 years old. The date of death is not available at the time of this report as there is no indication of specific serial number/patient information. Without a 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: Impact of a Practice-wide Switch from Traditional Right Ventricular Pacing to Left Bundle Branch Area Pacing. The Journal of Innovations in Cardiac Rhythm Management. 2025. 16(6):6297¿6305. DOI: 10.19102/icrm.2025.16064. 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.