BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 23794626 · Received December 12, 2025

    Report

    Report Number
    MW5180446
    Event Type
    Injury
    Date Received
    December 12, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ELA / SORIN CRM SAS
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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
    789258 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN ELA / SORIN CRM SAS ELAPASSP752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention