BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE PACEMAKER PULSE-GENERATOR

    MDR report key: 19333464 · Received May 15, 2024

    Report

    Report Number
    MW5155017
    Event Type
    Injury
    Date Received
    May 15, 2024
    Report Date
    March 1, 2024
    Manufacturer
    SORIN CRM SAS
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BLEEDING FROM PACEMAKER SCAR SIX DAYS POST IMPLANT WITH HOSPITALIZATION AND BANDAGING REDONE. 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
    1606499 IMPLANTABLE PACEMAKER PULSE-GENERATOR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY SORIN CRM SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention