BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPACE¿ LEAD, 65CM MRI

    MDR report key: 23400382 · Received October 28, 2025

    Report

    Report Number
    2017865-2025-1003423
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05415067046321
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF FAILURE TO CAPTURE AND NOISE WERE NOT CONFIRMED. A COMPLETE LEAD WAS RETURNED FOR ANALYSIS. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. VISUAL AND X-RAY INSPECTION OF THE LEAD DID NOT FIND ANY ANOMALIES.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION G3. THE CORRECT INITIAL AWARENESS DATE SHOULD HAVE BEEN (B)(6) 2025, RATHER THAN (B)(6) 2025 IN 2017865-2025-1003423.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PRESENTED FOR A FOLLOW-UP VISIT AT THE CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD EXHIBITED LOSS OF CAPTURE. AN X-RAY REVEALED THAT THE RA LEAD HAD DISLODGED, AND IT WAS SUBSEQUENTLY EXPLANTED AND REPLACED. DURING THE RIGHT VENTRICULAR (RV) LEAD REVISION FOR AN UPGRADE TO LEFT BUNDLE PACING, IT WAS OBSERVED THAT THE FIRST NEW RV LEAD HAD FAILED TO CAPTURE AND EXHIBITED NOISE REVERSION WHEN CONNECTED TO THE CHRONIC PACEMAKER. THE ISSUE PERSISTED EVEN AFTER THE LEAD WAS CONNECTED TO A NEW PACEMAKER, BUT IT WAS RESOLVED FOLLOWING APPROPRIATE PROGRAMMING OF THE RV LEAD. HOWEVER, THE FIRST NEW RV LEAD WAS NOT USED. THE PHYSICIAN ELECTED TO IMPLANT A SECOND NEW RV LEAD AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT REMAINED STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2735516 ULTIPACE¿ LEAD, 65CM MRI NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1231/65 P000231145 05415067046321

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male ASSURITY MRI PACEMAKER.| ULTIPACE LEAD.