Brief Summaries

DYNAGEN™ and INOGEN™ EL ICDs
Indications, Safety and Warnings

INDICATIONS AND USAGE
Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

CONTRAINDICATIONS
Use of these Boston Scientific pulse generators are contraindicated for the following: patients whose ventricular tachyarrhythmias may have reversible cause, such as: digitalis intoxication, electrolyte imbalance, hypoxia, sepsis; or patients whose ventricular tachyarrhythmias have a transient cause, such as: acute myocardial infarction (MI), electrocution, drowning; or patients who have a unipolar pacemaker.

WARNINGS
Read this 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. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks. 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. Patients should 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. Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home. Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day that Store EGM was enabled, the patient should not apply the magnet. 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. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias.)

PRECAUTIONS
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, supplemental precautionary information.

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 (shocks/pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of s hocking, fear of device failure, or imagined s hocking. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only. (Rev A)

DYNAGEN™ and INOGEN™ MINI ICDs
Indications, Safety and Warnings

INDICATIONS AND USAGE
Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

CONTRAINDICATIONS
Use of these Boston Scientific pulse generators are contraindicated for the following: patients whose ventricular tachyarrhythmias may have reversible cause, such as: digitalis intoxication, electrolyte imbalance, hypoxia, sepsis; or patients whose ventricular tachyarrhythmias have a transient cause, such as: acute myocardial infarction (MI), electrocution, drowning; or patients who have a unipolar pacemaker.

WARNINGS
Read this 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. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks. 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. Patients should 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. Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home. Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day that Store EGM was enabled, the patient should not apply the magnet. 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. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias.)

PRECAUTIONS
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, supplemental precautionary information.

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 (shocks/pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of s hocking, fear of device failure, or imagined s hocking. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only. (Rev A)

S-ICD™ System
Indications, Safety and Warnings

Indications for Use
The S-ICD™ System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

Contraindications
Unipolar pacemakers are contraindicated for use with the S-ICD System.

Warnings and Cautions
The S-ICD System contains sterile products for single use only. Do not resterilize. Handle the components of the S-ICD System with care at all times and maintain proper sterile technique. All Cameron Health implantable components are designed for use with the Cameron Health S-ICD System only. Connection of any S-ICD System components to any other ICD system will result in failure to deliver lifesaving defibrillation therapy.

General

  • External defibrillation equipment should be available for immediate use during the implantation procedure and follow-up.
  • Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response.
  • Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning. Defibrillation and excessive numbers of charging cycles shorten the battery longevity.
  • The S-ICD System has not been evaluated for pediatric use.
  • The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization Therapy (CRT) or Anti-Tachycardia Pacing (ATP).


Potential Adverse Events related to implantation of the S-ICD System may include, but are not limited to, the following:
Acceleration/induction of atrial or ventricular arrhythmia; Adverse reaction to induction testing; Allergic/adverse reaction to system or medication; Bleeding; Conductor fracture; Cyst formation; Death; Delayed therapy delivery; Discomfort or prolonged healing of incision; Electrode deformation and/or breakage; Electrode insulation failure; Erosion/extrusion; Failure to deliver therapy; Fever; Hematoma; Hemothorax; Improper electrode connection to the device; Inability to communicate with the device; Inability to defibrillate or pace; Inappropriate post-shock pacing; Inappropriate shock delivery; Infection; Keloid formation; Migration or dislodgement; Muscle stimulation; Nerve damage; Pneumothorax; Post-shock/post-pace discomfort; Premature battery depletion; Random component failures; Stroke; Subcutaneous emphysema; Surgical revision or replacement of the system; Syncope; Tissue redness, irritation, numbness or necrosis.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.

(Rev. D)

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