BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 4140429 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17448
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    March 24, 2008
    Report Date
    September 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    APPROXIMATELY SIX YEARS AGO, INFORMATION WAS RECEIVED THAT THE PACING IMPEDANCES FOR THIS RIGHT VENTRICULAR (RV) LEAD WERE BETWEEN 500 AND 300 OHMS. THEN A DECREASE TO 229 OHMS WAS NOTED, ALONG WITH A DECREASE IN SENSING. APPROXIMATELY ONE YEAR AGO, INFORMATION WAS RECEIVED THAT THE LEAD'S PACING IMPEDANCES WERE <200 OHMS AND HAD BEEN LOW FOR THE PREVIOUS YEAR. THE CAPTURE THRESHOLDS AND R-WAVE AMPLITUDES WERE STABLE. NO NOISE WAS NOTED ON THE LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE FIELD REPRESENTATIVE THAT FIVE YEARS AGO THE IMPEDANCES WERE ALREADY REPORTED TO BE LOW. THE FIELD REPRESENTATIVE REVIEWED THE INFORMATION WITH THE PATIENT'S CARDIOLOGIST, WHO WAS THEN GOING TO DISCUSS POSSIBLE DEFIBRILLATION THRESHOLD (DFT) TEST WITH AN ELECTROPHYSIOLOGY PARTNER. NO FURTHER INFORMATION WAS AVAILABLE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. FURTHER INFORMATION WAS RECEIVED THAT ON ROUTINE FOLLOW-UP THE RV PACING IMPEDANCE CONTINUES TO BE LESS THAN 200 OHMS. CAPTURE THRESHOLDS AND SENSING AMPLITUDE CONTINUE TO BE STABLE, AND THE SHOCK LEAD IMPEDANCE IS ALSO STABLE. NO NOISE ON THE LEAD HAS BEEN OBSERVED. THE PATIENT IS COMPLIANT WITH DEVICE FOLLOW-UP AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617837 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR T177| 0185| 4047