MEDTRONIC LEAD

Description of Event or Problem

LITERATURE WAS REVIEWED REGARDING LEFT BUNDLE BRANCH AREA PACING (LBBAP). THE AUTHORS DESCRIBED A PATIENT WHO DEVELOPED NEW-ONSET LEFT BUNDLE BRANCH BLOCK AND CARDIOMYOPATHY FOLLOWING SURGICAL RESECTION OF A SUBAORTIC MEMBRANE. THE PATIENT WAS IMPLANTED WITH CONVENTIONAL BIVENTRICULAR PACING, BUT THE LEFT VENTRICULAR (LV) LEAD REPEATEDLY DISLODGED DUE TO POOR CORONARY SINUS ANATOMY EVEN AFTER TWO PROCEDURES TO PLACE IT IN THE CORONARY SINUS BRANCH. THE LV LEAD WAS EVENTUALLY REMOVED AND REPLACED WITH LBBAP. 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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: LEFT BUNDLE BRANCH AREA PACING AFTER SUBAORTIC MEMBRANE RESECTION. JACC CASE REPORTS. 2026. 31:107546. DOI: 10.1016/J.JACCAS.2026.107546. 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.