BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY K SR

    MDR report key: 508502 · Received January 10, 2004

    Report

    Report Number
    2017865-2004-00035
    Event Type
    Injury
    Date Received
    January 10, 2004
    Date of Event
    October 10, 2003
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT THE DEVICE STOPPED PACING AND SENSING TWELVE HOURS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRONY K SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2535K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention