Contents: Cardiac pacing lead
||Minimum Introducer (F)
CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The OptiSense® Model 1999 lead is designed for permanent sensing and pacing in the right atrium in combination with a compatible pulse generator. Active-fixation leads such as the Model 1999 lead may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.
Contraindications: The OptiSense® Model 1999 lead is contraindicated: in the presence of tricuspid atresia, for patients with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.
Potential Adverse Events: Potential complications associated with the use of the lead are the same as with the use of any lead.
Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
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