BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17528593 · Received August 12, 2023

    Report

    Report Number
    MW5135523
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    June 16, 2021
    Manufacturer
    MEDTRONIC
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES. IT WAS NOTED IMPEDANCES INCREASED FROM 700-2236 OHMS HOWEVER, THERE WERE NO STORED EPISODES. THE RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    2204419 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 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown