BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1871151 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17627
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS SCHEDULED FOR A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. INFORMATION WAS LATER RECEIVED THAT THE RIGHT ATRIAL LEAD WAS ERODING THROUGH THE SKIN. AS A RESULT, THE ENTIRE SYSTEM WAS PLACED SUB-PECTORAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 4456| S602| 4469