BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRONY K SR

    MDR report key: 460380 · Received April 24, 2003

    Report

    Report Number
    2017865-2003-00155
    Event Type
    Malfunction
    Date Received
    April 24, 2003
    Date of Event
    January 1, 2003
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT AFTER LOW RATES WERE SEEN ON A HOLTER MONITOR, AN ATTEMPT TO INTERROGATE THE DEVICE WAS UNSUCCESSFUL AND THERE WAS NO RESPONSE TO MAGNET APPLICATION. A SUBSEQUENT INTERROGATION WAS ALSO UNSUCCESSFUL AND A DEVICE REPLACEMENT WAS SCHEDULED.

    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 23 MO