BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY K SR

    MDR report key: 688637 · Received March 10, 2006

    Report

    Report Number
    2017865-2006-00063
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    October 11, 2005
    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
    MN, 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 PACEMAKER FAILURE.

    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 25 MO Required Intervention