BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC LEAD

    MDR report key: 24179147 · Received January 26, 2026

    Report

    Report Number
    2182208-2026-01202
    Event Type
    Death
    Date Received
    January 26, 2026
    Date of Event
    August 1, 2025
    Report Date
    January 26, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    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. 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/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/68 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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 LOT NUMBER OR 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: TRANSVENOUS EXTRACTION OF QUADRIPOLAR CORONARY SINUS PACING LEADS. HEART RHYTHM. 2025. 22:E438¿E444. DOI: 10.1016/J.HRTHM.2025.03.1979 MEDTRONIC PRODUCTS REFERENCED: ATTAIN STABILITY QUAD MRI SURESCAN (4798) PRODUCT CODE OJX ATTAIN PERFORMA MRI SURESCAN (4298, 4398, 4598) PRODUCT CODE OJX ATTAIN OVER THE WIRE (4193, 4194) PRODUCT CODE LWP ATTAIN STARFIX (4195) PRODUCT CODE OJX ATTAIN ABILITY MRI SURESCAN (4196, 4296, 4396) PRODUCT CODE OJX 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 TRANSVENOUS EXTRACTION OF QUADRIPOLAR CORONARY SINUS (CS) PACING LEADS. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. LEADS WERE EXTRACTED DUE TO SEPSIS/ENDOCARDITIS, POCKET INFECTION, UNKNOWN LEAD FAILURES, AND FEVER. THERE WERE TWO MAJOR ADVERSE EVENTS RELATED TO THE EXTRACTIONS. ONE PATIENT WITH PREVIOUSLY MILD TRICUSPID REGURGITATION EXPERIENCED SEVERE TRICUSPID REGURGITATION WITH A FLAIL LEAFLET AND HEPATIC VEIN FLOW REVERSAL AFTER EXTRACTION. THE PATIENT REQUIRED SURGICAL TRICUSPID VALVE REPLACEMENT. ANOTHER PATIENT HAD PERICARDIAL TAMPONADE AFTER REMOVAL OF THE LEAD FROM THE CS. A SUBXIPHOID WINDOW WAS ATTEMPTED, BUT THE PATIENT WENT INTO CARDIAC ARREST AND REQUIRED CHEST COMPRESSIONS. A FULL STERNOTOMY WAS PERFORMED WITH RELIEF OF TAMPONADE AND RETURN OF HEMODYNAMIC STABILITY. PATIENTS WERE ATTEMPTED TO BE REIMPLANTED AND REASONS FOR FAILURE OF REIMPLANTATION INCLUDED STENOSIS, OCCLUSION, POOR THRESHOLDS, AND NON-CAPTURE. THE STATUS OF THE 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
    240145 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death UNKNOWN COMPETITOR CIED.