BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2042440 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01364
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EVENT AS A RESULT OF LOSS OF VENTRICULAR CAPTURE AND VENTRICULAR TACHYCARDIA. THE DEVICE AND LEAD REMAIN IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other 4137| 4480| S403