BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIPACE¿ LEAD, 46CM MRI

    MDR report key: 23894365 · Received December 25, 2025

    Report

    Report Number
    2017865-2025-1008208
    Event Type
    Injury
    Date Received
    December 25, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05415067046345
    PMA / PMN Number
    P960013
    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

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. IT WAS NOTED THAT THE ELECTROCARDIOGRAM (EKG) HAD CHANGED SINCE THE IMPLANT. THE PACEMAKER APPEARED TO HAVE MIGRATED AND BEEN TWIDDLED. THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD, AND LEFT BUNDLE BRANCH (LBB) LEAD WERE PULLED BACK AND DISLODGED. THE LBB LEAD WAS REPLACED WITH A NEW LBB LEAD. THE NEW LBB LEAD WAS DISLODGED DURING THE FIRST IMPLANTATION ATTEMPT AND BECAME CONTAMINATED WHILE SLITTING THE SHEATH. DURING SHEATH SLITTING, THE NEW LBB LEAD GOT CAUGHT AND WAS PULLED OUT ALONG WITH THE SHEATH. THE OLD LBB LEAD WAS EXPLANTED, THE NEW LBB LEAD WAS NOT USED AND REPLACED DURING THE PROCEDURE. NO INTERVENTIONS WERE PERFORMED ON THE PACEMAKER, THE RA LEAD, OR THE RV LEAD. THE PATIENT REMAINED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210253 ULTIPACE¿ LEAD, 46CM MRI NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1231/46 P000211926 05415067046345

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention