Maestro® Rechargeable System

Important Safety Information
For Patients

 

Important Safety Information for CE Mark Obesity Applications

Talk with your doctor about the full risks and benefits of VBLOC® Vagal Blocking Therapy and the Maestro® Rechargeable System.

What is the Maestro System Used For:

The Maestro Rechargeable System is intended to help you lose weight by using very small electrical signals to block the nerves that control digestion.

Who should not use the Maestro Rechargeable System:

The Maestro Rechargeable System should not be implanted in patients who are not good candidates for surgery or anesthesia, patients who are pregnant, patients with known allergies to the implantable components, and patients who have certain conditions (cirrhosis of the liver, high blood pressure, dilated esophageal veins or a significant hiatal hernia).

Warnings/Precautions/Adverse Events:

The Maestro Rechargeable system may be affected by or adversely affect medical procedures such as Magnetic Resonance Imaging (MRI), shock wave lithotripsy, ultrasound, radiation, diathermy or use of electrosurgical instruments. Maestro System parts may affect or be affected by other implanted devices, such as cardiac pacemakers and implanted defibrillators. Seek medical guidance prior to having any of these procedures or devices implanted or entering areas that could adversely affect system operation. Safety and effectiveness of the Maestro Rechargeable System has not been established for use with external defibrillation, during pregnancy, or for pediatric use. Talk with your doctor if you become pregnant while the Maestro Rechargeable System is implanted. Moving the implanted components may cause damage. The Maestro System must be kept charged to prevent damage. Portable outlets or extension cords should not be used with the AC recharger. Do not immerse external system parts in fluid. Keep strong magnets (eg, stereo speakers) at least 6 inches away from the implanted device. The Maestro Rechargeable System may set off metal or theft detector alarms. Do not use the mobile charger and transmit coil near metal or theft detectors, while aboard commercial aircraft, or in areas where electrostatic charges may be generated (eg, plastic slides). Patients with poor eyesight may not be able to operate the Maestro Rechargeable System. The capacity of the implanted rechargeable battery will reduce over time, requiring longer or more frequent charging.

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