BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIPACE¿ LEAD, 65CM MRI

    MDR report key: 25173059 · Received May 14, 2026

    Report

    Report Number
    2017865-2026-10085
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT
    Product Code
    NVN
    UDI-DI
    05415067046321
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN IN-CLINIC FOLLOW-UP AFTER INITIAL IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING PRE-SYNCOPAL EPISODES. AN INCREASE IN CAPTURE THRESHOLD RESULTING IN LOSS OF CAPTURE (LOC) WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND DISLODGEMENT WAS CONFIRMED. THE DEVICE WAS REPROGRAMMED AS IN INTERIM SOLUTION AND THEN THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE EVENT. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390124 ULTIPACE¿ LEAD, 65CM MRI No Match NVN ABBOTT LPA1231/65 P000248201 05415067046321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ASSURITY MRI