BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXA PRO MRI

    MDR report key: 24952327 · Received April 21, 2026

    Report

    Report Number
    MW5187108
    Event Type
    Other
    Date Received
    April 21, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 14, 2026
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    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 RIGHT VENTRICULAR (RV) EXHIBITED INTERMITTENT CAPTURE AT MAX OUTPUT. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT¿S CONDITION WAS STABLE. 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
    995548 PLEXA PRO MRI PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK SE & CO. KG S DX 65

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown