BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 17344533 · Received July 17, 2023

    Report

    Report Number
    MW5119546
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS EMAIL IS FOLLOWING UP A PREVIOUS COMPETITOR EMAIL FOR THIS PRODUCT IN RESPONSE TO AN EMAIL RECEIVED FROM MDT REP (B)(4). THE PATIENT WAS HAVING PACS. PROGRAMMED RA SENSITIVITY TO .3MV FROM .45MV. PAV TO 220. CHANGED MODE TO DDIR. TURNED OFF MVP. 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
    106811 SWEET TIP DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN BOSTON SCIENTIFIC CORPORATION 4269-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown