BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEGA STEROID-ELUTING ENDOCARDIAL LEADS (VEGA R52)

    MDR report key: 22495387 · Received July 14, 2025

    Report

    Report Number
    MW5172568
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 7, 2025
    Manufacturer
    MICROPORT CRM USA INC./ SORIN CRM SAS
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2025 AFTER RECEIVING TWO ALERTS FOR HIGH DEFIBRILLATION IMPEDANCE (<150 OHMS) ON THE RIGHT VENTRICULAR CHANNEL AND ¿LOW P WAVE CURRENT¿ ON THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ATRIAL CHANNEL ALSO EXHIBITED LOW PACING IMPEDANCE AT BELOW 200 OHMS. IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL PREVIOUSLY IN (B)(6) 2024 AFTER EXPERIENCING INAPPROPRIATE SHOCK DUE TO AN EPISODE OF ATRIAL FIBRILLATION FOLLOWED BY HIGH VENTRICULAR RATE. THE PRESENCE OF ATRIAL FIBRILLATION WAS STILL DETECTED AT THIS RECENT HOSPITAL VISIT. NO INTERVENTION WAS PERFORMED. THE PATIENT¿S CONDITION WAS STABLE. 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
    1647114 VEGA STEROID-ELUTING ENDOCARDIAL LEADS (VEGA R52) DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MICROPORT CRM USA INC./ SORIN CRM SAS VEGA R52

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown