![]() Potential 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. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated. Intended Use: The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.Ĭontraindications: There are no known contraindications for the insertion of the Assert-IQ ICM. With more than 40 years dedicated to improving lives through. Our innovations and commitment to the science of laboratory diagnostics marked the beginning of our modern diagnostics business. ![]() In 1972, Abbott launched its first hepatitis test and in 1985 launched the worlds first FDA approved HIV test. The Assert-IQ ICM has not been specifically tested for pediatric use. Driving diagnostic innovation since 1972. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. Indications for Use: The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. ![]() Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
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