BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1953549 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23748
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DATA FROM THIS DEVICE WAS SENT TO TECHNICAL SERVICES. TECHNICAL SERVICES DISCUSSED VARIOUS POSSIBILITES OF WHY SYNCOPE COULD BE SEEN AND RE-INFORCED MONITORING THE PATIENT ON A HOLTER MONITOR IN ORDER TO DETERMINE THE CAUSE OF THE REPORTED CLINICAL OBSREVATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD REMAINS IMPLANTED. AS THE DEVICE AND LEAD WILL NOT BE RETURNED NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS PI WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH A PULSE GENERATOR (PG) AND RIGHT VENTRICULAR (RV) LEAD EXPERIENCED WAS HOSPITALIZED DUE TO SYNCOPE. THE ELECTROCARDIOGRAM SHOWED CARDIAC ARREST. ALL DEVICE AND LEAD MEASUREMENTS APPEARED NORMAL. IT WAS NOTED THAT DURING CARDIAC ARREST NOISE WAS SEEN. NO FURTHER ANOMALIES WERE FOUND. THE PATIENT WILL BE MONITORED WITH A HOLTER MONITOR.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1