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Medtronic CardioSight Reader

Indications, Safety, and Warnings

Medtronic CareLink® Monitor/Medtronic CareLink Network

Intended Use

The Medtronic CareLink Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual.  These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician.

Contraindications

There are no contraindications for the Medtronic CareLink Monitor.

Warnings and Precautions

The Medtronic CareLink Monitor must only be used for interrogating compatible Medtronic implantable devices. The Medtronic CareLink Monitor is intended for use within the prescribing country.

The Medtronic CareLink programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

Paceart System

Intended Use

The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.

Contraindications

There are no known contraindications for the Paceart System.

Precautions

See the Paceart Manuals for more detailed information regarding precautions and use of the system. For further information regarding Paceart, please call Medtronic at 1 (800) 722-3278 and/or consult Medtronic's website at www.paceart.com.

9529 Reveal® XT Insertable Cardiac Monitor

The Reveal XT Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia. 

Contraindications

There are no known contraindications for the implant of the Reveal XT Insertable Cardiac Monitor. However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Warnings/Precautions

Patients with the Reveal XT 9529 Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual.

Potential Complications

Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

InSync Sentry® Models 7297/7299, Concerto® Model C154DWK, Virtuoso® Models D154AWG/D154VWC (DR/VR), Consulta®Model D224TRK (CRT-D), Secura® Models D224DRG (DR) and D224VRC (VR)

Indications

The InSync Sentry, Concerto and Consulta CRT-D systems are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias, and 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.

Virtuoso DR/VR and Secura DR and VR systems are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional class II/III heart failure. Due to the addition of the OptiVol diagnostic feature, the Virtuoso and Secura indications are limited to NYHA functional class II/III heart failure patients who are indicated for an ICD. The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure.

The Virtuoso DR, Secura DR, and Consulta CRT-D systems are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication.

Contraindications

The InSync Sentry and Concerto are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes; patients with incessant VT or VF; and patients who have a unipolar pacemaker.

Virtuoso DR/VR, Secura DR and VR, and Consulta CRT-D systems are contraindicated for patients experiencing any of the following conditions: tachyarrhythmias with transient or reversible causes, incessant ventricular tachycardia or ventricular fibrillation, present implant of a unipolar implantable pulse generator, primary disorder or bradyarrhythmia.  The Virtuoso DR and Secura DR systems are also contraindicated for patients who have a primary disorder of chronic atrial tachyarrhythmia with no concomitant VT or VF. Additionally, Virtuoso VR and Secura VR are contraindicated for patients who have a primary disorder of atrial arrhythmia.

Warnings and 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. For CRT-D devices, certain programming and device operations may not provide cardiac resynchronization.

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 tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.

IPG, ICD, CRT-D, CRT-P

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.

Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and 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. 

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.

ICDs and CRT ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, and for patients who have a unipolar pacemaker.

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 ICDs and 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.  An additional complication for ICDs and CRT ICDs is the acceleration of ventricular tachycardia.

2020A CardioSight Reader

Intended Use:

The Model 2020A CardioSight® Reader is intended for use in a clinical setting. The CardioSight Reader is indicated for use to interrogate compatible Medtronic implantable devices to collect patient and device data and send the information to the clinician. The 2020A CardioSight Reader cannot be used to change therapy.

Contraindications

There are no contraindications for the 2020A CardioSight Reader.

Warnings and Precautions

The CardioSight Reader must only be used for interrogating compatible Medtronic implantable devices.  Do not use a cellular phone while the antenna is positioned over the implanted device.  The CardioSight Reader is designed for use in the continental United States, Alaska and Hawaii.

See the device manual for detailed information regarding the instructions for use, 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 this device to sale by or on the order of a physician.