LINQ II™ ICM ISW
Brief statement for LINQ II™ insertable cardiac monitor system (ICM) and accessories
Indications
The LINQ II™ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:
- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
Contraindications
There are no known contraindications for the insertion of the LINQ II™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Warnings and precautions
Patients with the LINQ II™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical Procedure and EMI Warnings, Precautions, and Guidance Manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II™ MRI technical manual.
Accessories available for use with LINQ II™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.
Potential adverse events or potential complications
Potential adverse events from the LINQ II™ ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
There are no known adverse events associated with the use of any LINQ II™ ICM accessory.
See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).
Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.
Brief statement for AccuRhythm™ AI ECG classification system
Intended use
The intended use of the system is to reduce false positive cardiac arrhythmia episodes.
Contraindications
There are no known contraindications for AccuRhythm™ AI Models ZA400, ZA410, or ZA420.
Precautions
The AccuRhythm™ AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.
See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at (800) 328-2518.
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
MAJ_83662
