BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1952859 · Received January 7, 2011

    Report

    Report Number
    2124215-2011-00039
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    May 5, 2011
    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 RIGHT VENTRICULAR OUTPUTS WERE INCREASED AND THE PRODUCTS REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION FIVE MONTHS LATER THAT THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. THIS DEVICE REMAINS IMPLANTED WITH THE NEW LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED VENTRICULAR PACED MARKERS FOLLOWED BY VENTRICULAR SENSED MARKERS. NOISE WAS ALSO NOTED. TECHNICAL SERVICES REVIEWED AN ELECTROGRAM AND SUSPECTED LOSS OF CAPTURE OR OVERSENSING. THE FIELD REPRESENTATIVE COULD NOT REPRODUCE THE NOISE AND THE PHYSICIAN ORDERED A CHEST X-RAY. 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 S602

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR S602| 4135| 4136