Implant Detection

Implant Detection
Overview
Implant Detection is pacemaker feature designed to ensure that pacing and sensing polarities are set
appropriately at time of implant. In the event an out-of-range impedance is detected, the device ensures
capture by switching automatically to unipolar operation.
Programming
Implant Detection is nominally programmed to On/Restart. The other programming option is Off/Complete.
To program this feature, go to Params -> Additional Features ->
Implant Detection.
Immediately following insertion of the leads, it is imperative to ensure
capture. Implant Detection allows the polarity of the lead to be
programmed to unipolar if there is an out-of-range bipolar impedance
due to damage of the lead or incomplete insertion.
Implant Detection will also initiate features and data collection.
Feature Operation
The Implant Detection period begins when the leads are connected and establishes lead polarity (both atrial
and right ventricular). In CRT-P devices the LV lead is not configured by the Automatic Polarity Configuration
feature.
During the 30-minute Implant Detection period, impedance is measured at every paced event. In the event of
an out-of-range bipolar impedance measurement, a backup unipolar pace – Autopace – is provided to ensure
capture.
Auto Polarity Configuration delivers three asynchronous pulses at 85 bpm five minutes after lead connection
and again after 30 minutes to measure the impedance and determine which polarity should be set.
 If the system fails the bipolar test at the 5-minute mark, polarity is permanently set to unipolar.
 If the lead is bipolar, a second test at the 30-minute mark is conducted to further confirm polarity.
 Once polarity is set, Lead Monitor Only is switched on; this measures impedance at every paced
event and records out-of-range values.
 Note that plugged lead ports exhibit out-of-range impedances and will prevent completion of the
Implant Detection process. Therefore, if a plugged lead port is present, no data collection will begin
until Implant Detection is manually programmed to Off/Complete.
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An overview of the 30-minute Implant Detection process can be seen in this flow chart:
After 30 minutes, the pacemaker completes Implant Detection and activates the following features:
 Operating polarity (automatic configuration occurs during Implant Detection).
 Managed Ventricular Pacing (MVP)® operations including conduction checks and mode changes.
 Adaptive sensitivity settings (Sensing Assurance).
 Rate Response, including adaptive rate profile optimization (Rate Profile Optimization).
 Adaptive ventricular output settings for threshold management (Atrial Capture Management®, Left
Ventricular Capture Management, or Ventricular Capture Management).
 Diagnostic data collection.
 Search AV®+ initializes 60 minutes after Implant Detection is complete.
 All automatically adaptive features and diagnostics (eg, CareLink® data) are enabled after a
successful Implant Detection period. The adaptive features are identified by the up/down arrow
symbols on the programming screen available via the Parameters icon. All automatic diagnostics are
enabled.
 In the event that the implanting physician requests stopping Implant Detection in order to see Rate
Response or MVP in operation – two of the features suspended during Implant Detection, it is possible
to manually program the correct lead polarity and Implant Detection to Off/Complete.
 Mode Switch is automatically turned on after the leads are connected, and remains on throughout the
30-minute detection period. Atrial sensing and arrhythmia detection also continue during the Implant
Detection period.
Devices
Pacemakers
Advisa MRITM SureScan® Pacing System, Adapta® SR, Adapta DR, Versa® DR, Sensia® SR, Sensia DR
CRT-P
Consulta® CRT-P, Syncra® CRT-P
®
®
®
®
Sources: Medtronic Adapta /Versa /Sensia Reference Guide; Medtronic Consulta CRT-P Clinician Manual.
This document is provided for general educational purposes only and should not be considered the exclusive source for this
type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in
a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed
parameters or related features and results may vary. The device functionality and programming described in this document are
based on Medtronic products and can be referenced in the published device manuals.
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Indications, Safety, and Warnings
Brief Statement: IPGs and CRT IPGs
Indications
Implantable pulse generators (IPGs) are indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent
with increases in activity and increases in activity and/or minute ventilation. Pacemakers are also indicated for dual chamber and atrial tracking
modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of
conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial
contribution to cardiac output and VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm. For the MR conditional
IPGs, a complete pacing system consisting of a Revo MRI or Advisa MRI IPG and 2 SureScan leads is required for use in the MR environment.
CRT IPGs are indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients
who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a
prolonged QRS duration.
Contraindications
IPGs and CRT IPGs are contraindicated for dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias; asynchronous
pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms; unipolar pacing for patients with an implanted cardioverter
defibrillator because it may cause unwanted delivery or inhibition of ICD therapy; and certain IPGs are contraindicated for use with epicardial
leads and with abdominal implantation.
Warnings/Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources
of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage,
induction of an arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device.
Additionally, for CRT IPGs, certain programming and device operations may not provide cardiac resynchronization. Also for CRT IPGs, Elective
Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may experience loss of cardiac
resynchronization therapy and / or loss of AV synchrony. For this reason, the device should be replaced prior to ERI being set.
Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing,
failure to detect and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and
potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
© 2013 Medtronic, Inc.
Tel: (763) 514-4000
Fax: (763) 514-4879
Toll-free: 1 (800) 328-2518
(24-hour technical support for physicians and medical professionals)
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