BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONY K SR

    MDR report key: 688227 · Received March 10, 2006

    Report

    Report Number
    2017865-2006-00461
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    November 10, 2005
    Manufacturer
    ST JUDE MEDICAL AB
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 INTERMITTENT LOSS OF CAPTURE. THRESOLDS WERE 3.6 V, 1.0 MS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention