BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2060148 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05790
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXHIBITED A HEART RATE IN THE 30 BPM RANGE AND AS A RESULT HAD A SYNCOPAL EPISODE. A BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) INTERROGATED THE DEVICE AND FOUND NORMAL FUNCTION. THE PATIENT HISTOGRAMS WERE IN THE 50 BPM RANGE AND THERE WERE ATRIAL RATES NEVER SHOWED TO GO BELOW 50 BPM. THE ARRHYTHMIA LOGBOOK WAS EMPTY SHOWING NORMAL DEVICE FUNCTION. THE PATIENTS PHYSICIAN HAS DECIDED TO CONTINUE MONITORING PATIENT AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other 4472| S403| 4136