BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3070419 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06501
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT CONTACTED PATIENT SERVICES AND STATED THAT DURING DEVICE INTERROGATIONS SHE EXPERIENCES SYNCOPE. THE PATIENT WAS UNSURE AS TO WHAT TEST WAS BEING PERFORMED WHEN THE SYNCOPE OCCURRED. IT WAS ALSO NOTED THAT THERE WAS CONCERN OVER POSSIBLE LEAD ISSUE. THE FIELD REPRESENTATIVE NOTED THAT THE PATIENT HAS MISSED HER LAST TWO FOLLOW-UP APPOINTMENTS, THUS NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171316 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening S603| 4136| 4135