BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1950729 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22568
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SOME SYNCOPAL EPISODES. THE PATIENT IS NORMALLY ATRIAL PACING AND VENTRICULAR SENSING. THE SALES REPRESENTATIVE (SR) WAS QUESTIONING THE USE OF SUDDEN BRADY RESPONSE (SBR) AND TECHNICAL SERVICES (TS) STATED THAT WE DO HAVE SBR ON THIS DEVICE, HOWEVER IT CAN ONLY BE USED IF THE PATIENT IS 100% ATRIAL SENSED. THE DEVICE REMAINS PREPROGRAMMED AS IT WAS AND THE PATIENT WILL BE EVALUATED AT THE NEXT FOLLOW UP VISIT. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other S603| (B)(4)