Lead Integrity Alert |
Brief Statement: Medtronic Right Ventricular (RV) Lead Integrity Alert Feature
Intended Use: The RV Lead Integrity Alert feature is intended primarily for patients who have a Medtronic ICD or CRT-D device and a Sprint® Fidelis lead (Models 6949, 6948, 6931, and 6930). At the discretion of the clinician, the feature may be used with other chronic RV leads manufactured by Medtronic. The RV Lead Integrity Alert feature is only compatible with the following devices, Concerto, Virtuoso DR, Virtuoso VR, EnTrust, InSync Sentry, InSync Maximo, Intrinsic, Maximo DR, and Maximo VR. Contraindications: There are no known contraindications for the RV Lead Integrity Alert feature.
Warnings/Precautions:
- Device Electrical Reset – In the event of a Device Electrical Reset after installation, the RV Lead Integrity Alert feature is cleared from the device. However, the Patient Information screen and printed reports still indicate that the feature is installed. To restore the operation of the RV Lead Integrity Alert feature, it must be reinstalled into the device. Notify a Medtronic representative if a Device Electrical Reset has occurred.
- RV Lead Integrity Alert feature and therapy delivery – The RV Lead Integrity Alert feature improves the advance warning of a potential lead issue, but it does not withhold therapy for episodes that extend beyond the programmed VF NID. When the alert criteria are met and the audible alert tone sounds, the patient should seek immediate medical attention to prevent the delivery of an inappropriate shock.
See the reference manual for detailed information regarding the instructions for use, indications, contraindications, warnings, and precautions. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law ( USA) restricts this device to sale by or on the order of a physician.
Additional Information
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