BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2780955 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12981
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION NOTED BOTH SETSCREWS MOVED FREELY IN BOTH DIRECTIONS AND THE HEADER PASSED PIN GAGE TESTING. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, SENSING, AND RECORDING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER COMPLAINED OF SYNCOPE. A HOLTER MONITOR DEMONSTRATED A LOSS OF CAPTURE WITH THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. AS A RESULT THE PHYSICIAN ELECTED TO REPLACE THE WHOLE SYSTEM. NO FURTHER PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1295

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R MISMATCH| 1275| 1295| 6957J| K173| 4456| 285| 4135