BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELAPASSP752

    MDR report key: 24062926 · Received January 13, 2026

    Report

    Report Number
    3009660953-2026-00002
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    November 6, 2025
    Report Date
    January 13, 2026
    Manufacturer
    SORIN CRM SAS
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER MEDWATCH NOTICE: MW5180446: "IT WAS REPORTED THAT DURING A CLINIC VISIT, THE PATIENT WITH THE PACEMAKER SYSTEM REPORTED A SYNCOPAL EPISODE. DEVICE WAS INTERROGATED AND FOUND TO HAVE A LEAD SAFETY SWITCH (LSS) FROM BIPOLAR TO UNIPOLAR CONFIGURATIONS DUE LOW OUT OF RANGE PACING IMPEDANCES ON THIS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED FOR FURTHER REVIEW DUE TO SUSPICION OF LOSS OF CAPTURE (LOC) OF THE RV LEAD IN BIPOLAR CONFIGURATIONS. IT IS NOTED THAT THE LEAD IS A NON-(B)(6) LEAD. TS REVIEWED THE DATA AND DISCUSSED POSSIBLE CAUSES RECOMMENDING X-RAY IMAGES AND POSSIBLE LEAD REVISION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS NON-(B)(6) RV LEAD REMAINS IN SERVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114517 ELAPASSP752 RV LEAD NVN SORIN CRM SAS ELAPASSP752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other