Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures.

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

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. In addition, pacing and sensing in the left bundle branch area is indicated with a single or dual chamber pacemaker as an alternative to the right ventricle. (INGEVITY+)
• 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)
• Intended for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator (INGEVITY MRI extendable/retractable fixation)

CONTRAINDICATIONS

Use of this Boston Scientific lead is contraindicated for the following patients:

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

WARNINGS

General

• Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death.
• Backup defibrillation protection. Always have external defibrillation equipment available during implant and electrophysiologic testing. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient's death.
• Resuscitation availability. 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. Lead fracture, dislodgment, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing or sensing or both. 

Clinical Considerations

• (INGEVITY+) His Bundle Pacing. These leads have not been evaluated for safety and performance in His bundle pacing; therefore, they are not intended for implantation in the His bundle. Evidence indicates that there is increased risk with His bundle pacing, compared to conventional pacing, including increased implantation procedure duration, elevated pacing threshold, increased occurrence of lead dislodgment and sensing issues, and more rapid battery depletion.¹

Handling

• Excessive flexing. Although pliable, the lead is not designed to tolerate excessive flexing, bending, or tension. This could cause structural weakness, conductor discontinuity, and/or lead dislodgment.
• Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage.

Implant Related

• (INGEVITY+) Do not implant in MRI site Zone III. Implant of the system cannot be performed in an MRI site Zone III (and higher) as defined by the American College of Radiology^2. Some of the accessories packaged with pulse generators and leads, including the torque wrench and stylet wires, are not MR Conditional and should not be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
• (INGEVITY MRI) Do not implant in MRI site Zone III. Implant of the system cannot be performed in an MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document on MR Safe Practices^3. Some of the accessories packaged with pulse generators and leads, including the torque wrench and stylet wires, are not MR Conditional and should not be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
• (INGEVITY+) Ensure position on interventricular septum. Prior to fixation when implanting in the left bundle branch area, ensure the lead is positioned on the interventricular septum, not on the ventricular free wall. If the lead is not positioned on the interventricular septum, rotating the lead body could result in perforation and/or effusion.
• (INGEVITY+) Lead body rotation mechanism. The lead body rotation mechanism is only used for placement of the lead within the interventricular septum, not to anchor the distal tip of the lead to the endocardial surface of the right atrium or right ventricle.
• (INGEVITY+) Avoid perforation of interventricular septum when rotating lead body. To avoid perforation of the septum, monitor the location of the lead tip in the interventricular septum when rotating the lead body.
• (INGEVITY+) Helix entanglement. Acute lead repositioning in and/or removal from the interventricular septum may cause the helix to become entangled and may result in lead component separation or deformation, and/or damage to the endocardium, valve, or vein. To reduce this risk, re-orient the catheter to the position used for the original implant prior to repositioning the lead. Consider lead abandonment as an alternative.
• (INGEVITY+) Avoid excessive force. Avoid excessive forward force and/or torque on the lead and/ or catheter since these can damage the lead and/or cause tissue damage, such as cardiac perforation. Monitor electrical performance since abnormal values can indicate damage and/or tissue trauma.

Post-Implant

• Magnetic Resonance Imaging (MRI) exposure. 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, and significant harm to or death of the patient and/or damage to the implanted system may result. 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.
• Diathermy. Do not subject a patient with an implanted pulse generator and/or lead to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents.
• (INGEVITY+) Chronic removal of lead. In a chronic situation, exercise caution if a lead must be removed from the interventricular septum since the helix may become deformed and/or entangled which could result in lead component separation and/or damage to the endocardium, valve, or vein. Monitor the condition of the helix and lead during an attempt to remove the lead. Consider lead abandonment as an alternative.

PRECAUTIONS

Handling

• Do not immerse in fluid. Do not wipe or immerse the tip electrode in fluid. Such treatment will reduce the amount of steroid available when the lead is implanted.
• Chronic repositioning. Optimum threshold performance might not be achieved if the lead is chronically repositioned because the steroid can be depleted.
• Protect from surface contamination. The lead uses silicone rubber which can attract particulate matter, and therefore, must always be protected from surface contamination.
• No mineral oil on lead tip. Mineral oil should never come in contact with the helix. Mineral oil on the helix may inhibit tissue ingrowth and conduction.

Implantation

• (INGEVITY+) Do not over extend or over-retract the helix. Do not overextend or over-retract the helix. Exceeding the recommended maximum number of turns indicated in the specifications (Table 7 Specifications on page 36) may damage the conductor coil or fixation mechanism.
• (INGEVITY MRI extendable/retractable fixation) Do not overextend or over-retract the helix. Do not overextend or over-retract the helix. The lead conductor coil or fixation mechanism can be damaged or broken if you continue to rotate the terminal pin once the helix is fully extended or retracted.
• (INGEVITY MRI tined fixation) Do not use tined lead if withdrawn through introducer. Do not continue to use tined lead if it has been withdrawn through an introducer, since damage to the tines may occur.
• (INGEVITY+) Terminal pin maximum number of turns. Do not rotate the terminal pin clockwise or counterclockwise more than the recommended maximum number of turns indicated in the specifications (Table 7 Specifications on page 36). Continuing to rotate the terminal pin can damage the lead, cause a conductor coil break during fixation, cause lead dislodgment, tissue trauma, and/or cause acute pacing threshold to rise.
• (INGEVITY MRI extendable/retractable fixation) Terminal pin maximum number of turns. Do not rotate the terminal pin clockwise or counterclockwise more than the recommended maximum number of turns indicated in the specifications (Table 7 Specifications on page 36). 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.
• (INGEVITY+) Maximum lead body rotations. Do not exceed the recommended maximum number of fixation/positioning attempts and lead body rotations indicated in the specifications (Table 7 Specifications on page 36) during fixation/positioning attempts in the interventricular septum. Exceeding the recommended maximum number may damage the lead body and/or helix. It is recommended to replace the lead after 3 fixation/positioning attempts.
• (INGEVITY+) Helix pre-extension. If the helix is pre-extended prior to insertion into a lead delivery catheter, carefully insert the lead into the catheter to avoid damage to the helix.
• (INGEVITY+) Ensure a pre-extended helix remains within catheter. Whether the helix is preextended prior to or after insertion into the catheter, ensure the helix does not extend beyond the end of the catheter until the fixation step to prevent damage to the tissue and/or lead.
• (INGEVITY+) Prevent dislodgment. To prevent dislodgment, avoid rotating the terminal pin counterclockwise after fixating the lead.
• (INGEVITY MRI extendable/retractable fixation) Prevent dislodgment. To prevent dislodgment, avoid rotating the terminal pin after fixating the lead. 

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:

Acute or chronic septal perforation (INGEVITY+); Air embolism; Allergic reaction; Arterial damage with subsequent stenosis; Arteriovenous (AV) fistula (INGEVITY+); Bleeding; Bradycardia; Breakage/failure of the implant instruments; Cardiac perforation; Cardiac tamponade; Chronic nerve damage; Component failure; Conductor coil fracture; Coronary artery injury/acute coronary syndrome/myocardial infarction (INGEVITY+); 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; Prolonged exposure to fluoroscopic radiation (INGEVITY+); Prolonged procedure time (INGEVITY+); Pulse generator and/or lead migration; Renal failure from contrast media used during lead placement (INGEVITY+); Syncope; Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation; Thrombosis/thromboemboli; Trapped/damaged lead fixation helix (including unretrieved device fragment) (INGEVITY+);Valve damage; Vasovagal response; Venous occlusion; Venous trauma (e.g., perforation, dissection, erosion).

(INGEVITY+ & INGEVITY MRI tined fixation) Transient procedural adverse events are expected in some patients. These include, but are not limited to, discomfort, pain, and other systemic symptoms that might be related to medications or other interventions performed during implant.

(INGEVITY+ & INGEVITY MRI tined fixation) If adverse events occur, invasive corrective action and/or modification or removal of the pulse generator and/or lead may be needed. 

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.

Any serious incident that occurs in relation to this device should be reported to Boston Scientific using the information on the back cover and to the relevant local regulatory authority.

1. Zanon F, Ellenbogen KA, Dandamudi G, et al. Permanent His-bundle pacing: a systematic literature review and meta-analysis. Europace. 2018;20(11):1819-1826.

2. ACR Manual on MR Safety, version 1.0, 2020.

3. Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document on MR safe practices: 2013. J. Magn. Reson Imaging 2013;37:501-530.

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