BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT CORP

    MDR report key: 568285 · Received January 24, 2005

    Report

    Report Number
    MW1034474
    Event Type
    Injury
    Date Received
    January 24, 2005
    Date of Event
    October 29, 2004
    Report Date
    January 24, 2005
    Manufacturer
    CARDIAC RHYTHM MANAGEMENT GROUP
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A BIVENTRICULAR ICD IMPLANTATIN WHICH BECAME INFECTED WITH AN ATYPICAL MYCOBACTERIA A LITTLE OVER A MONTH POST-OP. PT PRESENTED WITH FEVER AND HAD TO HAVE THE DEVICE REMOVED AND BE TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT CORP LEFT VENTRICULAR LEAD-EASYTRAK IS-1 LWS CARDIAC RHYTHM MANAGEMENT GROUP 4538 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization