VISIONIST™, VISIONIST™ X4, VALITUDE™, VALITUDE™ X4, INTUA™, INVIVE™– IFU 51897536

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. 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.

INDICATIONS AND USAGE

Boston Scientific cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients with moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms and remain symptomatic despite stable optimal pharmacological therapy (OPT) for heart failure.

Atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony.

Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity. 

CONTRAINDICATIONS

These Boston Scientific pulse generators have the following contraindications:

• This device is contraindicated in patients who have a separate implanted cardioverter defibrillator (ICD) with transvenous leads.
• Unipolar pacing or use of the MV/Respiratory Sensor with a Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) is contraindicated because it may cause inappropriate therapy or inhibition of appropriate S-ICD therapy.
• Minute Ventilation is contraindicated in patients with both unipolar atrial and ventricular leads
• Single-chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction.
• Atrial tracking modes are contraindicated in patients with chronic refractory atrial tachyarrhythmias (atrial fibrillation or flutter), which might trigger ventricular pacing.
• Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. 
  

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.
• Separate pulse generator. Using multiple pulse generators could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery. Test each system individually and in combination to help prevent undesirable interactions ("Minimizing Pacemaker/S-ICD Interaction" on page 24).
• Safety Core operation. In response to applicable nonrecoverable or repeat fault conditions, the pulse generator will switch irreversibly to Safety Core operation. Safety Core pacing may be unipolar, which may interact with an ICD("Minimizing Pacemaker/S-ICD Interaction" on page 24). Safety Core behavior is affected by MRI Protection Mode. Refer to "Magnetic Resonance Imaging (MRI)" on page 21.

Handling

• 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.
• Handling the lead without Connector Tool. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. This could damage the lead terminal, possibly compromising the sealing integrity and result in loss of therapy or inappropriate therapy, such as a short within the header.
• Handling the terminal while tunneling. Do not contact any other portion of the IS4–LLLL lead terminal, other than the terminal pin, even when the lead cap is in place. 

Programming and Device Operations

• Lead Safety Switch. Lead Safety Switch should be programmed Off for patients with an ICD. Unipolar pacing due to Lead Safety Switch is contraindicated for patients with an ICD.
• Automatic Lead Recognition. Automatic Lead Recognition should be programmed to Off before implant for patients with an ICD. Unipolar pacing is contraindicated for patients with an ICD.
• RAAT testing. Unipolar pacing due to RAAT is contraindicated and should be programmed off for patients with an ICD. The RAAT feature performs automatic threshold testing in a unipolar pacing configuration.
• Sensitivity settings and EMI. If programmed to a fixed atrial Sensitivity value of 0.15 mV, or a fixed sensitivity value of 2.0 mV or less in a unipolar lead configuration in any chamber, the pulse generator may be more susceptible to electromagnetic interference. This increased susceptibility should be taken into consideration when determining the follow-up schedule for patients requiring such a setting. 

Post-Implant

• Protected environments. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. 
• Magnetic Resonance Imaging (MRI) exposure. VISIONIST X4 and VALITUDE X4 devices are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system. Significant harm to or death of the patient and/or damage to the implanted system may result. All other devices covered by this manual are not MR conditional. Do not expose patients with non-MR Conditional devices to MRI scanning. Strong magnetic fields may damage the pulse generator and/or lead system, possibly resulting in injury to or death of the patient. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide. For additional warnings, precautions, and Conditions of Use, refer to "Magnetic Resonance Imaging (MRI)" on page 21.
• 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. 

PRECAUTIONS

Clinical Considerations 

• Pediatric Use. The CRT-Ps have not been evaluated for pediatric use.
• STAT PACE. STAT PACE will initiate unipolar pacing. Unipolar pacing due to STAT PACE may cause inappropriate therapy or inhibition of appropriate S-ICD therapy. 
• MV Sensor modes. The safety and efficacy of the MV Sensor modes have not been clinically established in patients with abdominal implant sites.
• MV Sensor mode performance. MV Sensor performance may be adversely affected under transient conditions such as pneumothorax, pericardial effusion, or pleural effusion. Consider programming the MV Sensor Off until these conditions are resolved. 
  

Adaptive-rate modes based completely or in part on MV should not be used for patients with:

• An ICD
• Unipolar leads—for MV detection, a bipolar lead is required in either the atrium or ventricle
• A lead other than a bipolar transvenous lead—MV measurement has only been tested with a bipolar transvenous lead
• A mechanical ventilator—use of the ventilator might result in an inappropriate MV Sensor-driven rate 

Sterilization and Storage

• If device is dropped. Do not implant a device which has been dropped while outside of its intact shelf package. Do not implant a device which has been dropped from a height of more than 24 inches (61 cm) while within its intact shelf package. Sterility, integrity, and/or function cannot be guaranteed under these conditions, and the device should be returned to Boston Scientific for inspection.
• Storage temperature and equilibration. Recommended storage temperatures are 0°C–50°C (32°F–122°F). Allow the device to reach a proper temperature before using telemetry communication capabilities, programming, or implanting the device because temperature extremes may affect initial device function.
• Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets, and sources of EMI to avoid device damage. 

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 
• Bleeding 
• Bradycardia 
• 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 
• Inability to pace 
• Inappropriate pacing 
• Incisional pain 
• Incomplete lead connection with pulse generator Infection including endocarditis 
• Lead dislodgment 
• Lead fracture 
• Lead insulation breakage or abrasion 
• Lead perforation 
• Lead tip deformation and/or breakage 
• Local tissue reaction 
• Loss of capture 
• Myocardial infarction (MI) 
• Myocardial necrosis 
• Myocardial trauma (e.g., tissue damage, valve damage) 
• Myopotential sensing 
• Oversensing/undersensing 
• Pacemaker-mediated tachycardia (PMT) 
• Pericardial rub, effusion 
• Pneumothorax 
• Pulse generator migration 
• Shunting current during defibrillation with internal or external paddles 
• 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) 
• Worsening heart failure 

For a list of potential adverse events associated with MRI scanning, refer to the MRI Technical Guide. Patients may develop psychological intolerance to a pulse generator system and may experience the following:

• Dependency
• Depression
• Fear of premature battery depletion
• Fear of device malfunction

Additionally, potential adverse events associated with the implantation of a coronary venous lead system include:

• Allergic reaction to contrast media
• Breakage/failure of implant instruments
• Prolonged exposure to fluoroscopic radiation
• Renal failure from contrast media used to visualize coronary veins 
  

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