BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN CRM IMPLANTABLE PACEMAKER PULSE-GENERATOR

    MDR report key: 18275201 · Received December 5, 2023

    Report

    Report Number
    MW5148871
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Report Date
    October 19, 2023
    Manufacturer
    MICROPORT CRM USA INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. AN INSULATION FRACTURE IS SUSPECTED DUE TO SUBCLAVIAN CRUSH BASED ON X-RAY IMAGES. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    877015 SORIN CRM IMPLANTABLE PACEMAKER PULSE-GENERATOR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MICROPORT CRM USA INC. RF45D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown