BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2151491 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-05866
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WAS SEEN IN THE OFFICE FOR FOLLOW UP. THE DEVICE CHECK WAS NORMAL AND ALL PARAMETERS WERE WITH IN RANGE. THE PHYSICIAN NOTED SOME NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES THAT WERE TERMINATED APPROPRIATELY BY ANTI-TACHYCARDIA PACING. NO CHANGES WERE MADE TO THE DEVICE AS IT WAS DETERMINED THAT THERE WAS NO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION-THERAPY (CRT-D) REPORTED THAT HE WAS PICKING SOMETHING UP IN HIS GARAGE WHEN HE BEGAN FEELING WOOZY. THE NEXT THING HE KNEW, HE WAS SITTING ON THE FLOOR. HE NOTED THAT HE WAS DOWN THERE FOR AT LEAST A HALF AN HOUR. THE PATIENT WAS INSTRUCTED TO CALL HIS FOLLOWING PHYSICIAN. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H227

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening H170| H227| 4543| 0158| 4470