BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21829656 · Received April 11, 2025

    Report

    Report Number
    MW5168934
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Report Date
    January 31, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE AND DIZZINESS. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PACING PROBLEM, WHERE DEVICE WOULD LOSE CAPTURE OF PACING FOR NO REASON AT ALL, WHILE ALL NUMBERS ON THE COMPETITOR LEADS WERE STABLE AND CONSISTENT. PATIENT REQUIRED TEMPORARY PACING AS DEVICE KEPT LOSING CAPTURE EVEN AFTER SETTINGS ADJUSTMENT. DURING REVISION PROCEDURE WHEN NEW PACING LEAD PLACED, CAPTURING ISSUE PERSISTED EVEN WITH TEMPORARY PACING LEAD. IPG WAS REMOVED AND REPLACED. LEAD REV. (B)(6) 2024, FRACTURED SFJ 1388T CAPPED. TYRX PLACED. 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
    122800 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 ST. JUDE MEDICAL 1388TC -58

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other