BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1870836 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17231
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 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

    DUE TO THE NATURE OF THIS ISSUE, SHOULD THESE PRODUCTS GET RETURNED, ANALYSIS WOULD NOT BE REQUIRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACING SYSTEM WAS TAKEN OUT OF SERVICE DUE TO AN INFECTED POCKET. THE DEVICE WAS EXPLANTED AND BOTH LEADS WERE CUT NEAR THE POCKET AND ABANDONED IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO REPLACEMENT PROCEDURE IS SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 4036| 4087| 1280| S603