BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3211613 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09104
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY PROGRAMMED BACK TO THE DESIRED SETTINGS. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION OF THIS PACEMAKER, A POWER ON RESET MESSAGE WAS OBSERVED. IT WAS REPORTED THAT THE PATIENT UNDERWENT RADIATION THERAPY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT ALL DEVICE PARAMETERS WOULD NEED TO BE REPROGRAMMED AND RECOMMENDED SUBMITTING A COPY OF DEVICE MEMORY FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309389 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 4087| 4086| S403