BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1862146 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15659
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PACING SYSTEM WAS SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE CLINIC WITH THE PACEMAKER EXPOSED AND INFECTED. THE PHYSICIAN ADMITTED THE PATIENT TO THE HOSPITAL AND ADMINISTERED ANTIOBIOTICS FOR SEVEN DAYS AND REMOVED THE INFECTED SYSTEM. A NEW PACING SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 4480| 4457| 4136| 1298| S603