BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 23306863 · Received October 15, 2025

    Report

    Report Number
    2017865-2025-1002763
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 26, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW THE LOW VOLTAGE PACEMAKER MANUFACTURER REPORT 2017865-2025-1002763 SHOULD NOT HAVE BEEN SUBMITTED AS MEDICAL DEVICE REPORT (MDR) AS THE NEW INFORMATION RECEIVED THAT THE TEMPORARY PACEMAKER WAS INSERTED FOR RV LEAD LOSS OF CAPTURE DUE TO DISLODGEMENT. NO ALLEGATION OR MALFUNCTION OF THE PACEMAKER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A RIGHT VENTRICLE (RV) LEAD AND A PACEMAKER (PM) ON (B)(6) 2025. AFTER DISCHARGED FROM THE PROCEDURE, THE PATIENT¿S HEART RATE HAD DROPPED, AND THE PM HAD FAILED TO CAPTURE. IT WAS ALSO IDENTIFIED THAT THE RV LEAD FAILED TO CAPTURE AT HIGH OUTPUT. A CHEST X-RAY WAS PERFORMED AND CONFIRMED THAT THE RV LEAD WAS DISLODGED. THE PHYSICIAN ELECTED TO INSERT A TEMPORARY PACEMAKER ON (B)(6) 2025. SUBSEQUENTLY, THE RV LEAD WAS EXPLANTED ON (B)(6) 2025, AND A NEW LEAD WAS REPLACED. THE PATIENT WAS RECOVERING POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694106 ASSURITY MRI IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000178367 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention 2088TC/52 TENDRIL