BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2082282 · Received May 9, 2011

    Report

    Report Number
    2124215-2011-08112
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    January 12, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS SUSPECTED ATRIAL OVERSENSING DURING ATRIAL TACHYCARDIA RESPONSE. THE PATIENT REPORTED TURNING GRAY WHILE AT WORK. A CONNECTION ISSUE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Description of Event or Problem · 1

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE PATIENT WAS SEEN FOR A CLINIC VISIT AND ALL VALUES WERE WITHIN NORMAL RANGE. NO SYSTEM ANOMALIES WERE NOTED.

    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 77 YR S606| 4470| 4471