BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17520723 · Received August 12, 2023

    Report

    Report Number
    MW5127671
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    September 19, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ST. JUDE MEDICAL
    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) 2012 AND WAS CAPPED ON (B)(6) 2016 DUE TO LEAD REPAIR, IMPEDANCE 240-181 OHMS WITH NOTED RV NOISE. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6). 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
    762647 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 2088TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown