BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT RIGHT ATRIAL LEAD

    MDR report key: 24392812 · Received February 19, 2026

    Report

    Report Number
    2017865-2026-03475
    Event Type
    Injury
    Date Received
    February 19, 2026
    Report Date
    February 19, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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). " DETAILS SUCH AS PATIENT AND DEVICE INFORMATION WAS NOT PROVIDED AS THIS RESEARCH ARTICLE WAS PERFORMED RETROSPECTIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT A PATIENT HAD BOTH THEIR RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS DISCOVERED TO BE FRACTURED. THE RA AND RV LEADS WERE EXPLANTED. THE PATIENT'S CONDITION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448216 ABBOTT RIGHT ATRIAL LEAD No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RA LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention