International Only - Not intended for physicians in the U. S. or Japan
Cardioblate® MAPS Mapping, Ablation, Pacing, and Sensing Device
Indications, Safety and Warnings
Indications: The Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is intended to ablate cardiac tissue using radiofrequency energy for the treatment of cardiac arrhythmias when connected to the Cardioblate® 68000 generator, or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary pacemaker.
Contraindications: The Cardioblate MAPS Mapping, Ablation, Pacing, and Sensing Device should not be used for patients that have active endocarditis at the time of surgery.
Adverse Effects: Possible complications related to the use of this instrument in combination with cardiac surgery are: tissue perforation, extension of extracorporeal bypass, perioperative heart rhythm disturbances (atrial and/or ventricular), postoperative embolic complications, pericardial effusion or tamponade, injury to the vessels, valve leaflet damage, conduction disturbances (SA/AV node), acute ischemic myocardial event, thrombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion, esophageal perforation.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.
For further information, please call Medtronic at (877) 526-7890 or visit www.medtronic.com.
