Indications, Safety and Warnings

EMBLEM™ MRI S-ICD System

INDICATIONS FOR USE

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

CONTRAINDICATIONS

Unipolar stimulation and impedance-based features are contraindicated for use with the S-ICD System.

WARNINGS

Concomitant use of the S-ICD System and implanted electromechanical devices (for example implantable neuromodulation/neurostimulation systems, ventricular assist device (VAD), or implantable insulin pump or drug pump) can result in interactions that could compromise the function of the S-ICD, the co-implanted device, or both. The S-ICD is intended as lifesaving therapy and should be seen as priority in the decision and evaluation of concomitant system implants over non-lifesaving applications. Electromagnetic (EMI) or therapy delivery from the co-implanted device can interfere with S-ICD sensing and/or rate assessment, resulting in inappropriate therapy or failure to deliver therapy when needed. In addition, a shock from the S-ICD pulse generator could damage the co-implanted device and/or compromise its functionality. Verify sensing configuration, operation modes, surgical considerations and existing placement of all involved devices prior to any co-implant. To help prevent undesirable interactions, test the S-ICD system when used in combination with the co-implanted device, and consider the potential effect of a shock on the co-implanted device. Induction testing is recommended to ensure appropriate detection and time to therapy for the S-ICD and appropriate post-shock operation of the co-implanted device. Failure to ensure appropriate detection and time to therapy delivery of the S-ICD system could result in patient injury or death. Following completion of the interaction testing, thorough follow-up evaluation of all co-implanted devices should be performed to ensure that device functions have not been compromised. If operational settings of the co-implanted devices change or if patient conditions changes which may affect S-ICD sensing and therapy performance, re-evaluation of the co-implanted devices may be required.  Do not expose a patient with an implanted S-ICD System to diathermy. EMBLEM S-ICD devices are considered MR Conditional. Unless all MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system. The Programmer is MR Unsafe and must remain outside the MRI site Zone III. During MRI Protection Mode the Tachycardia therapy is suspended. MRI scanning after ERI status has been reach may lead to premature batter depletion, a shortened device replacement window, or sudden loss of therapy. The Beeper may no longer be usable following an MRI scan.

Do not expose a patient with an implanted S-ICD System to diathermy. EMBLEM S-ICD devices are considered MR Conditional. Unless all MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system. The Programmer is MR Unsafe and must remain outside the MRI site Zone III. During MRI Protection Mode the Tachycardia therapy is suspended. MRI scanning after ERI status has been reach may lead to premature batter depletion, a shortened device replacement window, or sudden loss of therapy. The Beeper may no longer be usable following an MRI scan. The pulse generator may be more susceptible to low frequency electromagnetic interference at induced signals greater than 80 uV. The S-ICD System has not been evaluated for pediatric use.

PRECAUTIONS

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow up testing, explant and disposal, supplemental precautionary information.

POTENTIAL ADVERSE EVENTS

Potential adverse events related to implantation of the S-ICD System may include, but are not limited to, the following: Acceleration/induction of atrial or ventricular arrhythmia, adverse reaction to induction testing, allergic/adverse reaction to system or medication, bleeding, conductor fracture, cyst formation, death, delayed therapy delivery, discomfort or prolonged healing of incision, electrode deformation and/or breakage, electrode insulation failure, erosion/extrusion, failure to deliver therapy, fever, hematoma/seroma, hemothorax, improper electrode connection to the device, inability to communicate with the device, inability to defibrillate or pace, inappropriate post shock pacing, inappropriate shock delivery, infection, injury to or pain in upper extremity, including clavicle, shoulder and arm, keloid formation, migration or dislodgement, muscle/nerve stimulation, nerve damage, pneumothorax, post-shock/post-pace discomfort, premature battery depletion, random component failures, stroke, subcutaneous emphysema, surgical revision or replacement of the system, syncope, tissue redness, irritation, numbness or necrosis.

Patients who receive an S-ICD System may develop psychological disorders that include, but are not limited to, the following: depression/anxiety, fear of device malfunction, fear of shocks, phantom shocks.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.

(Rev. E) 046774 AH

 

LATITUDE NXT Patient Management System from Boston Scientific CRM

INTENDED USE

The LATITUDE NXT Patient Management System is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database.  The LATITUDE NXT System provides patient data that can be used as part of the clinical evaluation of the patient.

CONTRAINDICATIONS

The LATITUDE NXT Patient Management System is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE NXT System. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.

PRECAUTIONS

Alerts may appear on the LATITUDE NXT website on a daily basis. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. The clinician needs to log onto the LATITUDE NXT website in order to receive alerts. Although secondary notification through email and SMS

text messages is available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the website.  Implanted device data and alerts are typically available for review on the LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to 14 days may elapse before the LATITUDE NXT server detects these conditions and informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following:  System limitations; the Communicator is unplugged; the Communicator is not able to connect to the LATITUDE NXT server through the configured phone system; the implanted device and the Communicator cannot establish and complete a telemetry session; the Communicator is damaged or malfunctions; the patient is not compliant with prescribed use or is not using the

LATITUDE NXT System as described in the patient manual; if subscribed to the LATITUDE Cellular Data Plan, missing two or more payments discontinues the subscription; the clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List.

ADVERSE EFFECTS:

 None known.

SYSTEM LIMITATIONS:

The LATITUDE NXT System does not provide continuous real-time monitoring. As a remote monitoring system, the LATITUDE NXT System provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of implanted device, sensor, and patient information as intended by the clinician. These factors include: implanted device clock; patient environment; cellular data service; telephone system; communicator memory capacity; clinic environment; schedule/configuration changes; or data processing.

Refer to the product labeling for specific instructions for use. Rx only.

(Rev. D) 046774 AH

 

EMBLEM S-ICD Automated Screening Tool

Intended Use
The AST application is solely intended to screen patients for S-ICD implant and is not intended to be used for any cardiac diagnostic purpose. The AST is an alternative to the Model 4744 Patient Screening Tool. The two screening tools serve the same purpose, and may be used independently or together.
Indications for Use/Contraindications/Warnings and Precautions
There are no indications/contraindications, warnings or precautions specific to the Model 2889 EMBLEM S-ICD Automated Screening Tool (AST). Refer to the appropriate S-ICD System Pulse Generator (PG) User Manual for a list of indications for use, allowed concomitant device settings, contraindications, and warnings and precautions for the S-ICD system. Refer to the product labeling for specific instructions for use. Rx only.

(Rev A) 046774 AH

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