Brief Statements for:

LATITUDE® Patient Management System from Boston Scientific CRM

Intended Use

The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible pulse generator from BSC CRM and transfer data to a central database.

Contraindications

The LATITUDE system is contraindicated for use with any pulse generator other than a compatible pulse generator from BSC CRM. For contraindications for use related to the pulse generator, refer to the System Guide for the pulse generator being interrogated.

Precautions

The LATITUDE system is designed to notify clinicians within 24 hours if new pulse generator alert conditions are detected by the Communicator. However, alert notification cannot occur if:
Up to two weeks may elapse before the LATITUDE system detects the events mentioned above and additional time may be required for notification and resolution of the condition.

Adverse Effects

None known.
Refer to the product labeling for specific instructions for use. Rx only.
(Rev. G)

ZOOM® LATITUDE® Programming System from Boston Scientific CRM

Intended Use

The Model 3120 Programmer/Recorder/Monitor (PRM) is intended to be used as a complete system to communicate with Guidant implantable pulse generators.

The software in use controls all communication functions for the pulse generator. For detailed software application instructions, refer to the System Guide for the Guidant pulse generator being interrogated.

Contraindications

The Model 3120 PRM is contraindicated for use with any pulse generator other than a Guidant device. For contraindications for use related to the Guidant pulse generator, refer to the System Guide for the Guidant pulse generator being interrogated.

Warnings

There are no warnings associated with this programming system.

Precautions

For information on precautions, read the following sections of the product labeling: General, Preparation for Use, Maintenance and Handling.

Adverse Effects

None known.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse effects. Rx only.
(Rev. C)

ICD Systems from Boston Scientific CRM

ICD Indications and Usage

ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. ICDs with atrial therapies are also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias.

Contraindications

Use of ICD systems are contraindicated in: Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4) sepsis, or whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. Patients who have a unipolar pacemaker.

Warnings

Refer to the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system. Such damage can result in injury to, or death of, the patient. Program the pulse generator ventricular Tachy Mode to Off during implant, explant or post-mortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator paddles or an equivalent (eg, R2 pads) immediately available during conversion testing. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient’s death. Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient require external rescue. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient.

Precautions

For information on precautions, refer to the following sections of the product labeling: sterilization, storage and handling; implantation and device programming; follow-up testing; pulse generator explant and disposal; environmental and medical therapy hazards; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential Adverse Events

Potential adverse events from implantation of the ICD system include, but are not limited to, the following: allergic/physical reaction, death, erosion/migration, fibrillation or other arrhythmias, fracture/insulation break (lead or accessory), hematoma/seroma, inappropriate therapy, infection, lead tip deformation and/or breakage, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management, and component failure. 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. J)

CRT-D Systems from Boston Scientific CRM

Indications and Usage

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms.

Contraindications

There are no contraindications for this device.

Warnings

Refer to the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in injury to, or death of, the patient. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator paddles or an equivalent (eg, R2 pads) immediately available during conversion testing. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient's death. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not subject a patient with an activated implanted pulse generator to diathermy since diathermy may damage the pulse generator. Do not use atrial-tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. Do not use atrial only modes in patients with heart failure because such modes do not provide CRT. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. Do not use defibrillation patch leads with the CRT-D system, or injury to the patient may occur. Do not use the CRT-D with a separate pacemaker system. This combination could result in CRT-D/pacemaker interaction. The emulator is not intended for use as a permanent lead electrode and must be removed from the patient. It is for one-time use only. Do not resterilize.

Precautions

For information on precautions, refer to the following sections of the product labeling: sterilization, storage and handling; implantation and device programming; follow-up testing; pulse generator explant and disposal; environmental and medical therapy hazards; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential Adverse Events

Potential adverse events from implantation of the CRT-D system include, but are not limited to, the following: allergic/physical reaction, death, erosion/migration, fibrillation or other arrhythmias, fracture/insulation break (lead or accessory), hematoma/seroma, inappropriate therapy, infection, lead tip deformation and/or breakage, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management, and component failure. 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. I)