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 Boston Scientific 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 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.

Precautions

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 will typically be 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 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 establish and 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 becomes damaged or it 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 and 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 will be 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 reviewing supporting diagnostic information stored in the implanted device and viewing information on the LATITUDE clinician website.

Adverse Effects

None known.

Refer to the product labeling for specific instructions for use. Rx only.
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