BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2162613 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07045
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    February 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE MONTH POST IMPLANT OF THIS PACEMAKER WITH NON-BOSTON SCIENTIFIC LEADS, REDNESS AND PURULENT DISCHARGE WERE NOTED AT THE POCKET SITE. ORAL ANTIBIOTIC MEDICATION WAS PRESCRIBED. A WOUND CULTURE CONFIRMED (B)(6). NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    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 61 YR Other MISMATCH| S602