BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE PACEMAKER PULSE-GENERATOR

    MDR report key: 20864414 · Received December 5, 2024

    Report

    Report Number
    MW5163304
    Event Type
    Injury
    Date Received
    December 5, 2024
    Report Date
    September 24, 2024
    Manufacturer
    SORIN CRM SAS
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE DEVICE HAD EXHIBITED INFECTION. A REVISION WAS PERFORMED AND THE DEVICE ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. THE PHYSICIAN OPTED TO IMPLANT A LEADLESS PACEMAKER. NO ADDITIONAL 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
    95272 IMPLANTABLE PACEMAKER PULSE-GENERATOR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY SORIN CRM SAS 2250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown