Indications, Safety, and Warnings

Brief Statement: Medtronic MyCareLink™ Patient and CareLink® Monitors, Medtronic CareLink Express™ Monitor, Medtronic CareLink® Network, Medtronic CareLink™ Mobile Application, Medtronic CareLink™ Patient Information Site, Medtronic CardioSight Reader and Medtronic Programmer

These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability, alert notifications, and patient messages are subject to internet connectivity and access, and service availability. The CareLink and MyCareLink Patient Monitors must be on and in range of the device. Physician alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

Brief Statement: Medtronic MyCareLink™ Patient and CareLink^® Monitors, Medtronic CareLink Express™ Monitor, Medtronic CareLink^® Network, Medtronic CareLink™ Mobile Application, Medtronic CareLink™ Patient Information Site, Medtronic CardioSight Reader and Medtronic Programmer

Intended Use

The MyCareLink Patient Monitor, CareLink Monitor, CareLink Express Monitor, and 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. The CareLink Express Monitor is for use in a clinical setting with Medtronic implantable cardiac devices. The CareLink Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. The CareLink Patient Information Site is intended to provide patients, their friends / family and caregivers messages regarding transmission status of patient device diagnostic data to the CareLink Network. The CardioSight Reader is intended for use in a clinical setting and indicated for use to interrogate compatible Medtronic implantable devices to collect patient and device data and send the information to the clinician. The CardioSight Reader cannot be used to change therapy. 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. CareLink Network and CareLink Patient Information Site availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the internet is required for the CareLink Mobile App and subject to coverage availability. Standard text message and data rates apply. Message frequency depends on account settings and clinic scheduling.

For US Text SMS Messages:

Visit www.myMedtronicCareLink.net to receive text messages by enrolling to our Short code 53671.
Reply HELP for text message Help (Non-Medical information regarding text messaging)
Reply STOP to cancel the text messages. Alternatively the user can change account settings via the CareLink Patient Information Site: www.myMedtronicCareLink.net
User must be 18 years or older or have permission from a parent or guardian to participate. *Terms and Conditions are available at www.myMedtronicCareLink.net
Supported Text Message Carriers: Our participating carriers include (but not limited to): AT&T, Sprint, Boost, Verizon Wireless, U.S. Cellular^®, T-Mobile^®.

Web browsers currently supported by the CareLink Patient Information Site are: Microsoft^® Internet Explorer for Windows Version 8.x and Version 9.x, Mozilla Firefox^® for Windows Version 13.x, Google Chrome™ for Windows Version 20.x.

Contraindications

There are no known contraindications.

Warnings and Precautions

The MyCareLink Patient Monitor, CareLink Monitor and CareLink Express Monitors and 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 CareLink Monitor, CareLink Express Monitor and CardioSight Reader are intended for use within the prescribing country.

Brief Statement: 2090 Programmer

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.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.

Paceart System

Brief Statement: 9529 Reveal® XT and 9528 Reveal® DX Insertable Cardiac Monitors

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)

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.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.

Medtronic CareLink Network