TELIGEN® Implantable Cardioverter Defibrillator - ICD

The LATITUDE system is contraindicated for use with any pulse generator other than a compatible pulse generator from Boston Scientific CRM. Not all Guidant or Boston Scientific pulse generators are compatible with the LATITUDE system. For contraindications for use related to the Guidant or Boston Scientific pulse generator, refer to the System Guide for the pulse generator being interrogated.

The LATITUDE system is designed to notify clinicians within 24 hours if new pulse generator alert conditions are detected by the Communicator. Alert notifications are based on clinician configured alert settings. Pulse generator data is typically available for review on the LATITUDE system within 15 minutes of a successful interrogation. However, data availability and alert notification can take up to 24 hours or the next business day. Note that pulse generator data will not be available and alert notification cannot occur if:

• The Communicator is unplugged or is not able to connect to the LATITUDE system through an active phone line.


• The pulse generator and the Communicator cannot complete a telemetry session. This session must be initiated by the patient if he or she has a pulse generator that uses inductive telemetry.


• The Communicator is damaged or malfunctions.


• The patient is not compliant with prescribed use or is not using the LATITUDE system as described in the patient manual.

Up to two weeks may elapse before LATITUDE first detects the conditions mentioned above. Additional time may be required for clinic notification and resolution of the condition. During this time, no new patient data, device data, or alert notifications since the last successful data transmission are available.

Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care. Alerts can be verified by viewing information on the LATITUDE clinician website and reviewing supporting diagnostic information stored in the implanted device.

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

ICD Indications and Usage
ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. ICDs (i.e. Vitality AVT) 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.

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.

Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system.. Program the pulse generator ventricular Tachy Mode to Off during implant, explant or post-mortem procedures. Always have sterile external and internal defibrillator protection available during implant. Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing. 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.

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; post-therapy pulse generator follow-up. Advise patients to avoid sources of electromagnetic interference (EMI).

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

Do not expose a patient to MRI device scanning. Do not subject a patient with an implanted pulse generator to diathermy. Do not use atrial tracking modes (or an AVT device) in patients with chronic refractory atrial tachyarrhythmias (applies to dual-chamber devices only.) Do not use this pulse generator with another pulse generator. Do not kink, twist or braid lead with other leads.

For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead and 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.

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, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, 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. O)