BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1871195 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18056
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INFORMATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INTERMITTENT CAPTURE WAS SEEN DUE TO AN EXIT BLOCK ON THE RIGHT VENTRICULAR CHANNEL. DAILY MEASUREMENTS SHOW NORMAL AND STABLE LEAD IMPEDANCES. THE PULSE GENERATOR (PG) HAS BEEN REPROGRAMMED. THE RIGHT VENTRICULAR LEAD IS A COMPETITOR LEAD. 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 S501

    Patients

    Seq Age Sex Outcome Treatment
    1