BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY K SR

    MDR report key: 414351 · Received July 9, 2002

    Report

    Report Number
    2017865-2002-00511
    Event Type
    Injury
    Date Received
    July 9, 2002
    Date of Event
    March 27, 2002
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED REGARDING THE EXPLANTED DEVICE NOTES INFECTION.

    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