BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA LEAD

    MDR report key: 17533443 · Received August 12, 2023

    Report

    Report Number
    MW5140347
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    March 20, 2022
    Manufacturer
    UNKNOWN
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIA I (RA) LEAD EXHIBITED POSSIBLE OVERSENSING. (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
    1355509 RA LEAD PERMANENT PACEMAKER ELECTRODE DTB UNKNOWN 4053

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown