BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2780440 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12447
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 13, 2012
    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

    THE DEVICE REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS PACEMAKER EXHIBITED AN UNEXPECTED CHANGE IN BATTERY STATUS WITH 3.5 YEARS LONGEVITY REMAINING. ALL OTHER MEASUREMENTS WERE NORMAL. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1