By Prescription Only
Indications: The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Jot Dx™ ICM has not been specifically tested for pediatric use.
Intended Use: The Jot Dx™ ICM is intended to help physicians monitor, diagnose and document the rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms, as indicated.
Contraindications: There are no known contraindications for the insertion of the Jot Dx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
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