INGEVITY™ MRI Leads are intended for chronic pacing and sensing in the right atrium (only preformed atrial J with the Tined Fixation) and/or right ventricle (only straight with the tined fixation) when used with a compatible pulse generator.
Use of these leads are contraindicated in: patients with a hypersensitivity to a nominal single dose dexamethasone acetate: 0.61 mg for Tined Fixation, 0.91 mg for Extendable Retractable Fixation; and patients with mechanical tricuspid heart valves.
Refer to the product labeling before implanting the lead to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Lead fracture, dislodgment, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing or sensing or both. Although pliable, the lead is not designed to tolerate excessive flexing, bending, or tension. Do not kink, twist, or braid the lead with other leads. Implant of the system cannot be performed in an MRI site Zone III (and higher). Take care to obtain appropriate electrode position. Failure to do so may result in suboptimal lead measurements. Unless all of the MRI Conditions of Use (as described in the MRI Technical Guide) are met, MRI scanning of the patient does not meet MR Conditional requirements of the implanted system. Refer to the MRI Technical Guide for potential adverse events applicable when Conditions of Use are met or not met, as well as a complete list of MRI-related Warnings and Precautions. Do not subject a patient with an implanted pulse generator and/or lead to diathermy.
For Extendable/Retractable Fixation: The safety and efficacy of the tip electrode placement in the right ventricle above midseptum has not been clinically established.
Refer to the implant product labeling for cautions specific to clinical considerations, sterilization and storage, handling, implantation, hospital and medical environments, and follow up testing of the lead. Failure to observe these cautions could result in incorrect lead implantation, lead damage/dislodgment, or harm to the patient. Prior to implantation of this lead, confirm lead/pulse generator compatibility. Lead fracture, dislodgment, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing or sensing or both. Defibrillation equipment should be kept nearby during the implant procedure. Optimum threshold performance might not be achieved if the lead is chronically repositioned because the steroid can be depleted.
For Extendable/Retractable Fixation: Avoid creating sharp bends while extending or retracting the helix. Sharp bends can increase the risk of breaking the conductor coil or fixation mechanism during helix extension or retraction. Do not rotate the terminal pin clockwise or counterclockwise more than the recommended maximum number of turns indicated in the specifications. Continuing to rotate the terminal pin once the helix is fully extended or retracted (as indicated by fluoroscopy) can damage the lead, cause a conductor coil break during fixation, cause lead dislodgment, tissue trauma, and/or cause acute pacing threshold to rise.
Potential Adverse Events
Potential adverse events include, but are not limited to the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, procedure-related, and component failure. In rare cases severe complications or device failures can occur.
For a list of potential adverse events associated with MRI scanning, refer to the MRI Technical Guide.
Refer to the physician’s manual(s) for specific indications, contraindications, warning/precautions and adverse events. Rx only (Rev. A)