LUX-Dx™ Insertable Cardiac Monitor System

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.

The LUX-Dx has not been tested specifically for pediatric use.

CONTRAINDICATIONS

There are no known contraindications for the insertion of the LUX-Dx insertable cardiac monitor. However, the patient’s particular medical condition may dictate whether or not they can tolerate a subcutaneous, chronically-inserted device.

LATITUDE Clarity is contraindicated for use with any device other than a compatible Boston Scientific device.

WARNINGS

Patients with the LUX-Dx ICM have some warnings to be aware on topics such as, but not limited to, Co-implanted device interaction, diathermy, magnet compatibility, magnet use, and protected environments. For a complete list of warnings and description of each read the LUX-Dx Insertable Cardiac Monitor System User Manual.

PRECAUTIONS

For specific information on precautions, refer to the Precautions section of the User’s Manual or the following sections of the product labeling: General, Clinical Considerations, Sterilization and Storage, Insertion, Magnet, Device Programming, Environmental and Medical Hazards, Follow-up, Device Removal and Disposal.

POTENTIAL ADVERSE EVENTS

Potential adverse events related to insertion of the device may include, but are not limited to,

• Device migration

• Erosion

• Foreign body rejection phenomena

• Formation of hematomas or seromas

• Infection

• Local tissue reaction

• Tissue damage

• Potential adverse events related to device operation may include, but are not limited to, 

• Premature battery depletion

• Sensing issues

• Error codes

• Loss of telemetry

Potential adverse events related to device operation may include, but are not limited to, 

• Premature battery depletion

• Sensing issues

• Error codes

• Loss of telemetry

Transient procedural adverse events are expected in some patients. These include, but are not limited to discomfort, pain, anxiety, and other systemic symptoms that might be related to medications or other interventions performed during implant.

Refer to the manuals on LUX-Dx for additional detailed information on implant procedure, indications, intended use, contraindications, warnings, precautions, and potential adverse events at www.bostonscientific-elabeling.com

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