Pacing Leads from Boston Scientific:

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS

This Boston Scientific lead is indicated for use as follows:

• intended for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator (INGEVITY+ and INGEVITY MRI extendable/retractable fixation)
• intended for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator (INGEVITY MRI tined fixation)

CONTRAINDICATIONS

Use of these leads are contraindicated for the following patients:

• Patients with a hypersensitivity to a nominal single dose of 0.91mg dexamethasone acetate (for INGEVITY+ and INGEVITY MRI extendable retractable fixation)
• Patients with a hypersensitivity to a nominal single dose of 0.61mg dexamethasone (for INGEVITY MRI tined fixation)
• Patients with mechanical tricuspid heart valves.

WARNINGS

Read the manual thoroughly before implantation 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 INGEVITY+ and INGEVITY MRI extendable/retractable fixation: The safety and efficacy of the tip electrode placement in the right ventricle above midseptum has not been clinically established.

PRECAUTIONS

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, handling, implantation, hospital and medical environments, and follow-up testing.

POTENTIAL ADVERSE EVENTS

Based on the literature and on pulse generator and/or lead implant experience, the following alphabetical list includes the possible adverse events associated with implantation of products described in this literature: Air embolism; Allergic reaction; Arterial damage with subsequent stenosis; Bleeding; Bradycardia; Breakage/failure of the implant instruments; Cardiac perforation; Cardiac tamponade; Chronic nerve damage; Component failure; Conductor coil fracture; Death; Electrolyte imbalance/dehydration; Elevated thresholds; Erosion; Excessive fibrotic tissue growth; Extracardiac stimulation (muscle/nerve stimulation); Fluid accumulation; Foreign body rejection phenomena; Formation of hematomas or seromas; Heart block; Hemorrhage; Hemothorax; Inability to pace; Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing); Incisional pain; Incomplete lead connection with pulse generator; Infection including endocarditis; Lead dislodgment; Lead fracture; Lead insulation breakage or abrasion; Lead tip deformation and/or breakage; Malignancy or skin burn due to fluoroscopic radiation; Myocardial trauma (e.g., tissue damage, valve damage); Myopotential sensing; Oversensing/undersensing; Pericardial rub, effusion; Pneumothorax; Pulse generator and/or lead migration; Syncope; Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation; Thrombosis/thromboemboli; Valve damage; Vasovagal response; Venous occlusion; Venous trauma (e.g., perforation, dissection, erosion).

For a list of potential adverse events associated with MRI scanning, refer to the ImageReadyTM MR Conditional Pacing System or Defibrillation System MRI Technical Guide.

92436283 (Rev. B)