BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17523661 · Received August 12, 2023

    Report

    Report Number
    MW5130609
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    August 28, 2019
    Report Date
    November 2, 2020
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SENSING ISSUE: 5874 SHORT V-V INTERVALS SINCE (B)(6) 2019 20:18:46. (B)(4). 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
    595931 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 ABBOTT MEDICAL 1346T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown