BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1950488 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22616
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO OF THE EXPLANTED PRODUCTS ARE INTENDED TO BE RETURNED FOR POST MARKET EVALUATIONS. IF A PRODUCT IS RETURNED IN THE FUTURE, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO PATIENT INTERFERENCE AT THE IMPLANTED SITE. IT WAS REPORTED THAT EROSION WAS EVIDENT AS THE RESULT OF CONTINUOUS MANIPULATIONS. THE DEVICE AND ASSOCIATED RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS WERE EXPLANTED. MICROBIOLOGY SAMPLES TESTING FOR INFECTION WERE NECESSARY AND ANTIBIOTICS ADMINISTERED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 4097| 4096| S606