BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPACE¿ LEAD, 52CM MRI

    MDR report key: 22093946 · Received May 28, 2025

    Report

    Report Number
    3008377825-2025-00004
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 16, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05415067046314
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF HELIX MECHANISM ISSUE WAS CONFIRMED BUT HELIX DAMAGE WAS NOT CONFIRMED. AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN ONE PIECE WITH THE HELIX PARTIALLY EXTENDED AND CLOGGED WITH BLOOD/TISSUE. VISUAL AND X-RAY EXAMINATION OF THE LEAD DID NOT FIND ANY ANOMALIES. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. AFTER CLEANING THE HELIX, THE HELIX COULD BE EXTENDED AND RETRACTED BY APPLYING TORQUE TO THE CONNECTOR PIN. THE MEASURED FULL HELIX EXTENSION LENGTH WAS WITHIN SPECIFICATION. THE CAUSE OF HELIX MECHANISM ISSUE WAS ISOLATED TO THE HELIX BEING CLOGGED WITH BLOOD/TISSUE.

    Additional Manufacturer Narrative · 0

    CORRECTION: D3 - THE CORRECT MANUFACTURER ESTABLISHMENT NAME SHOULD BE ST. JUDE MEDICAL, INC.(CRM-SYLMAR) INSTEAD OF ST. JUDE MEDICAL OPERATIONS (M) SDN BHD. G8 - MANUFACTURER REPORT NUMBER SHOULD HAVE STARTED WITH 2017865 NOT AS SUBMITTED 3008377825-2025-00004.

    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 AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE HELIX OF THE RIGHT ATRIAL LEAD WAS DAMAGED. IT WAS ALSO NOTED THAT THE HELIX FAILED TO BE EXTENDED AND RETRACTED. THE LEAD WAS NOT USED AND REPLACED DURING THE PROCEDURE. PATIENT STATUS WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332158 ULTIPACE¿ LEAD, 52CM MRI NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1231/52 P000226718 05415067046314

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female