BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17518189 · Received August 12, 2023

    Report

    Report Number
    MW5125137
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    May 7, 2018
    Report Date
    July 10, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RV LEAD WAS IMPLANTED ON (B)(6) 2017 AND REMAINS IMPLANTED AT THIS TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON 05/07/2018 STATING THAT THERE WAS A PERIODIC SPIKES IN IMPEDANCE WITH ONE GREATER THAN 3000 OHMS. ON 05/07/2018 AND 06/11/2018 LEAD SAFETY SWITCH WAS PRESENT EVEN MINUTE VENTILATION (MV) SENSOR WAS OFF, STILL THERE WAS AN EPISODE SHOWING NOISE WHEN LEAD IS IN UNIPOLAR AND NO ASYSTOLE NOTED GREATER THAN 2 SECONDS. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) CENTER. NO OTHER INFORMATION IS AVAILABLE. 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
    2117565 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 MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown