BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1050542 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01513
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 31, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED IN THE CLINIC AFTER BEING LOST TO FOLLOW-UP SINCE DATE OF IMPLANT (50 MONTHS). THE PULSE GENERATOR COULD NOT BE INTERROGATED WITH SEVERAL PROGRAM- MERS. MAGNET RESPONSE WAS LESS THAN 100 PPM. AN ATTEMPT TO PERFORM A DOWNLOAD FAILED. THE DEVICE WAS SUBSEQUENTLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention