BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1851904 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14266
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 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 THE CLINICAL OBSERVATIONS, ANALYSIS WOULD NOT BE REQUIRED SHOULD THE PRODUCTS GET RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED A (B)(6) INFECTION AT THE DEVICE POCKET SITE. AS A RESULT, THE PACING SYSTEM WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED DURING THE EXPLANT PROCEDURE.

    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 89 YR Required Intervention S603| 4088| 4087