BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1050461 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01442
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    ATTEMPTS TO INTERROGATE THE PULSE GENERATOR WERE UNSUCCESSFUL. THE MEASURED BATTERY DATA FOUR MONTHS PREVIOUS WAS 2.68 V, 15 UA, 8.9 KOHMS. THE PATIENT WAS NOT PACEMAKER DEPENDENT. 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