BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 3041180 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03407
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE PACING IMPEDANCES GREATER THAN 2000 OHMS AND A LOSS OF CAPTURE (LOC) WERE OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. THE LOCAL FIELD REPRESENTATIVE DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TESTING VARIOUS PROGRAMMING CONFIGURATIONS FOR ROOT CAUSE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT CAPTURE AND OUT OF RANGE IMPEDANCE MEASUREMENTS WERE RESTORED BY CHANGING THE LV PACING VECTOR. AN ISSUE WAS FOUND WITH THE LEAD ELECTRODE TIP THAT WAS THE CONCLUDED CAUSE TO THE ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144313 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H227

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R 1290| 4088| 4137| 4271| H217| H227| 4087| 0184| 1270| 4086| 4543| 4035