Maestro® Rechargeable System

Important Safety Information
For Physicians (US Obesity Full Version

 

Important Safety Information

Carefully read the Maestro® Rechargeable System Instruction manuals for complete indications, contraindications, warnings, precautions and potential adverse events, and full instructions.

Indications:

The Maestro Rechargeable System is indicated for use in weight reduction in patients aged 18 years through adulthood who have a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one supervised weight management program within the past five years.

Contraindications:

The Maestro Rechargeable System should not be implanted in patients who have cirrhosis of the liver, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging (MRI) is planned; patients at high risk for surgical complications; patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis; or patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is planned.

Warnings/Precautions/Adverse Events:

Certain medical therapies or procedures may cause patient injury, nerve damage, burns, heating, or pain; may cause damage to or dislodgement of the implanted device; and may turn therapy off. These include shock wave lithotripsy, radiation, mono polar electrosurgical instruments, positron emission tomography scans, and radiofrequency ablation. Patients who attempt to move the implanted components (“twiddler’s syndrome”) may move, damage or disconnect the system components. The Maestro System components must be kept charged to prevent damage to system components, which may require additional surgery to replace the implanted neuroregulator. The neuroregulator should be fully charged prior to turning it off. Lead impedance testing should only be performed using equipment approved by EnteroMedics to prevent leakage current which could injure the patient. Continued therapy with a fractured lead may cause pain, inflammation or nerve damage. The Maestro System is MR Unsafe, including for patients in which the Maestro System was explanted and not all components were removed. Maestro System components may interact with other implanted devices, such as cardiac pacemakers, defibrillators, spinal cord and peripheral nerve stimulators, other neurostimulators, and body worn devices such as insulin pumps. Portable outlets or extension cords should not be connected to the AC recharger. Do not immerse external system components in fluid. Keep strong magnets at least 6 inches away from the implanted device. The Maestro Rechargeable System may activate metal detectors or other security systems. Strong magnetic fields and RF emitters, including RFID systems, may interfere with the function of the Maestro System. The neuroregulator and mobile charger should be turned off in the presence of metal detectors, other security systems, strong magnetic fields and RF emitters including RFID systems. The mobile charger should be turned off while aboard aircraft. The Maestro Rechargeable System should only be implanted by surgeons who have received training in its implantation. Infection at the implant site may occur and could require use of antibiotics, surgery, or device explant. Do not modify any components of the system. Interference from radio frequency transmitters in close proximity to system components may impact function of the Maestro System. Safety and effectiveness of the Maestro Rechargeable System has not been established for use within a hyperbaric chamber, with external defibrillation, during pregnancy, or for use in patients under 18 years of age. The capacity of the rechargeable neuroregulator battery will diminish over time, requiring longer or more frequent charging. Patients with impaired vision may not be able to operate the Maestro System.

The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, dysphagia, eructation, wound redness or irritation, and constipation.