BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC CAPSURE(R) SP MODEL 5524M PACING LEADS

    MDR report key: 22214979 · Received June 16, 2025

    Report

    Report Number
    MW5171557
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 11, 2025
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE, MANAGEMENT / MEDTRONIC INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC REMOTELY VIA DATA TRANSMISSION WITH EPISODES OF ATRIAL FIBRILLATION (AF). UPON EXAMINATION, NOISE WAS OBSERVED ON THE (B)(6) RIGHT ATRIAL (RA) AND BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD RESULTING IN NOISE REVERSION. THE LEADS WERE REPROGRAMMED TO UNIPOLAR MODE. NO FURTHER INFORMATION IS KNOWN. "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
    33503 MEDTRONIC CAPSURE(R) SP MODEL 5524M PACING LEADS PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC CARDIAC RHYTHM DISEASE, MANAGEMENT / MEDTRONIC INC. 5524M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown