BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3213001 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10592
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS RECENTLY SEEN FOR FOLLOW UP AND IT WAS NOTED THAT THE DEVICE DID NOT INCREASE PACING AS NEEDED DURING ACTIVITY AND THE PATIENT WAS EXPERIENCING SYNCOPAL AND NEAR SYNCOPAL EVENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED SOME PROGRAMMING CHANGES INCLUDING TURNING ON RATE RESPONSE. THE PATIENTS DEVICE PROGRAMMING WAS CHANGED AND THAT WAS SUSPECTED TO ALLEVIATE ALL ISSUES. THE FOLLOWING DAY THE PATIENT CAME BACK IN FOR A TREADMILL TEST, AND NEARLY PASSED OUT AGAIN. AGAIN, THE DEVICE PROGRAMMING WAS CHANGED. THE DEVICE REMAINS IMPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313911 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R S603| 4457| 4480