RV Lead Integrity Alert
Update to the Model 9995 programmer software
Clinician Manual Supplement
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the
United States and possibly in other countries. All other trademarks are the property
of their respective owners.
CardioSight, CareAlert, CareLink, Concerto, Consulta, Maximo, Medtronic,
Medtronic CareAlert, Medtronic CareLink, Quick Look, Secura, Sprint Fidelis,
TherapyGuide, Virtuoso
Medtronic RV Lead Integrity Alert
1 Introduction
1.1 About this supplement
This Clinician Manual supplement describes the new capabilities provided by an update to
the Model 9995 software. This document is a supplement to the Clinician Manuals for the
following Medtronic products:
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Consulta CRT-D
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Concerto II CRT-D
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Maximo II CRT-D
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Secura DR
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Virtuoso II DR
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Maximo II DR
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Secura VR
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Virtuoso II VR
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Maximo II VR
1.1.1 Supporting clinical studies
Information regarding clinical studies related to this software update is available at
www.medtronic.com/manuals. To view, download, print, or order clinical studies from the
Medtronic website, perform the following steps:
1. Navigate your web browser to http://www.medtronic.com/manuals.
2. Set the “Your Location” option to United States and click [OK].
3. Select the “Search for:” field on the left side of the screen and type “9995”.
4. Click [Search].
The following clinical studies are relevant to this software update:
The Enhanced Surveillance of Right Ventricle Lead Integrity Alert (RV LIA) – This
study, which prospectively assessed the performance of the Right Ventricle Lead Integrity
Alert, provided an estimate of the probability of receiving a three-day warning for patients
with a lead fracture.
RV Lead Integrity Alert retrospective evaluation – This retrospective evaluation
assessed the ability of the RV Lead Integrity Alert feature to provide advance notice of a
Sprint Fidelis lead fracture. The evaluation provides support for the RV Lead Integrity Alert
feature.
1.2 Manual conventions
The programmer screen image examples in this manual were produced using a Medtronic
CareLink Model 2090 programmer. These screen images are provided for reference only
and may not match the software for your patient’s specific device.
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Medtronic RV Lead Integrity Alert
The names of on-screen buttons are shown within brackets: [Button Name].
Programming instructions in this manual are often represented by a programming block,
which describes the path through the application software to specific screens or parameters.
The following conventions are used in programming blocks:
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The “⇒” symbol precedes the screen text you can select to navigate to a new screen.
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The “▷” symbol precedes the name of a parameter you can program for a feature.
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When a navigation step refers to a field on the screen that is labeled with both a row title
and a column title, the “ | ” character is used to divide the two separate titles. Parameter
values, however, do not use this convention.
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When a particular value for a parameter must be selected to make the remaining
parameters or navigation possible, that value appears within <brackets>.
Here is an example of a programming block using these conventions:
Select Params icon
⇒ Screen text to select…
⇒ Screen field Row Title | Column Title…
▷ Parameter Name <Required Value>
▷ Parameter Name
▷ Parameter Name
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Medtronic RV Lead Integrity Alert
2 System update description
2.1 New system capabilities
The updated version of the Model 9995 software makes the following modifications to the
device:
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The RV Lead Integrity Alert feature is added to the device.
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The audible alert tones for CareAlert notifications related to the RV lead are changed.
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Several TherapyGuide parameter suggestions are updated.
The modifications to the device occur automatically when the device is interrogated by a
Medtronic CareLink Model 2090 Programmer that has the updated version of the Model
9995 software installed. If the interrogated device has not yet been implanted, the
modifications occur automatically and without notification. The Device Tone and Patient
Home Monitor parameters for the RV Lead Integrity Alert are available for programming,
and are intially set to Off. If a previously-implanted device is interrogated, the programmer
displays a message indicating that the RV Lead Integrity Alert has been added to the device.
In addition, the Device Tone and Patient Home Monitor parameters for the RV Lead Integrity
Alert are programmed to On.
RV Lead Integrity Alert feature – The RV Lead Integrity Alert feature is designed to extend
the advance warning time of a potential lead-related issue, improve opportunities for more
patients to recognize the audible alert, and reduce inappropriate shocks. The RV Lead
Integrity Alert feature is intended for patients who have a Medtronic ICD or CRT-D device
and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data.
Performance data for use of the RV Lead Integrity Alert feature in combination with other
leads is not currently available. The RV Lead Integrity Alert feature is not intended to withhold
therapy for true VT or VF. To identify a potential lead issue, the RV Lead Integrity Alert
monitors RV pacing lead impedance measurements, the frequency of rapid non-sustained
VT episodes, and the frequency of short ventricular intervals counted on the Sensing
Integrity Counter.
Changes to RV lead CareAlert tones – When the device is updated with the RV Lead
Integrity Alert feature, a new 30 s alert tone is added for lead-related CareAlert events. The
following CareAlert tone behavior applies to the RV Lead Integrity Alert, the RV Pacing Lead
Impedance Out of Range Alert, and the RV Defibrillation and SVC Defibrillation Lead
Impedance Out of Range Alerts:
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A 30 s alert tone sounds immediately, and then every 4 hours beginning at the next
scheduled 4-hour time interval (12:00 AM, 4:00 AM, 8:00 AM …).
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A 10 s alert tone sounds at the programmed alert time.
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