BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT RIGHT ATRIAL LEAD

    MDR report key: 24415344 · Received February 23, 2026

    Report

    Report Number
    2017865-2026-03687
    Event Type
    Injury
    Date Received
    February 23, 2026
    Report Date
    February 23, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION FOR THIS EVENT WAS OBTAINED FROM A LITERATURE REVIEW ARTICLE: DETAILS ARE LISTED IN THE ARTICLE, TITLED ¿INTRAVASCULAR LITHOTRIPSY TO FACILITATE EXTRACTION OF VERY OLD CARDIAC IMPLANTABLE ELECTRONIC DEVICES LEADS. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, FEBRUARY SUPPLEMENT 2026. DOI: [10.1111/JCE.70280] (HTTPS://DOI.ORG/10.1111/JCE.70280), JAMIE KOWAL, TRAVIS RICHARDSON, GEORGE H CROSSLEY. NOTE: THE PATIENT AND PRODUCT INFORMATION WAS NOT AVAILABLE DUE TO THE NATURE OF THE SOURCE OF THE EVENT WHICH IS A LITERATURE REVIEW ARTICLE.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE REVIEW ARTICLE INVESTIGATING THE USE OF SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) USED TO EXTRACT OLD LEADS WITH CHALLENGES AFFECTED BY DENSE CALCIFICATION SURROUNDING THE LEADS AND POSSIBLY PREVENTING THE ADVANCEMENT OF AN EXTRACTION SHEATH THAT A RETROSPECTIVE STUDY WAS CONDUCTED IN 24 PATIENTS. 49 LEADS WERE EXTRACTED USING IVL WITH AN AVERAGE OF 2 LEADS PER PATIENT. THE INDICATION FOR EXTRACTION FOR ONE OF THE PATIENTS INVOLVED IN THIS RETROACTIVE STUDY WAS LEAD FRACTURE AND EXTRACTION OF BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) ABBOTT LEADS. AFTER IVL TREATMENT, THE LEADS WERE EXTRACTED USING CONVENTIONAL LASERS, WHEN NECESSARY, WITH MECHANICAL TOOLS. ALL TRANSVENOUS LEADS WERE SUCCESSFULLY REMOVED AND THERE WERE NO SIGNIFICANT COMPLICATIONS. DETAILS ARE LISTED IN THE ARTICLE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2026, TITLED "INTRAVASCULAR LITHOTRIPSY TO FACILITATE EXTRACTION OF VERY OLD CARDIAC IMPLANTABLE ELECTRONIC DEVICES LEADS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478878 ABBOTT RIGHT ATRIAL LEAD No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RA LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention