TIPS AND TRICKS FOR ALERT MANAGEMENT

TIPS AND TRICKS FOR ALERT MANAGEMENTReveal LINQ™ Insertable Cardiac Monitoring System

Consider the below guidance when consistently reviewing non-actionable alerts

Too Many Alerts “No Data Available” Repeated Alert False Episodes

CareAlert: AF CareAlert: Brady/Pause/Tachy

Max Episodes (auto or symptom)

Other

See “Optimizing CareAlerts.”

See “Device Reprogramming.”

If Implant date precedes Dec ’14, request a manual download

AF episodes < 10 min for these devices do not automatically send in daily wireless audits.

Request manual download

§ An in-clinic data clear may have occurred.

§ Wireless audits may have been missed on too many consecutive days.

Request manual download

Manual download will reset the maximum episode flag (in-clinic visit not required).

Go to patient’s overview page and ensure all reports have been opened. An unviewed report may trigger an additional alert notification.

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TROUBLESHOOTING CAREALERT™ NOTIFICATIONS

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CAREALERT NOTIFICATIONS GUIDANCE FOR REVEAL LINQ™ ICM PATIENTSConsider enabling the following CareAlert Notifications to receive information that may be near term or immediately actionable in your care plan for each patient. The decision to enable CareAlerts should be weighed against the work flow of your clinic to receive and analyze reports. Data collected wirelessly during the month is available on each patient’s automatically generated Summary Report.

CareAlert SetupTo manage the amount of data from Reveal LINQ ICM patients, we recommend setting up CareAlerts by patient.

* Only for patients with low EF or structurally abnormal hearts (higher VT risk). ** Only when implant signals have been confirmed within guidelines.

Syncope AF DiagnosisCryptogenic Stroke and Suspected AF

AF MonitoringAblation ManagementMedical Management

Suspected VT

Clinical Management Alerts

Reveal LINQ Wireless Device Alert ConditionsRed Alert

No Alert

Yellow Alert

Website-only Alert

Symptom (Patient Activated) Episode

Symptom (Patient Activated) + Detected Episode

Tachy Episode

Pause Episode

Brady Episode

AF Episode

AT Episode

AT /AF Daily Burden > Threshold

Time:

Average Ventricular Rate during AT/AF

Time:

Maximum Episode Count Met

Maximum Symptom (Patient Activated) Count Met

Low Battery Voltage Recommended Replacement Time:

Electrical Reset

V. Rate:

Red Alert

No Alert

Yellow Alert

Website-only Alert

Red Alert

No Alert

Yellow Alert

Website-only Alert

Red Alert

No Alert

Yellow Alert

Website-only Alert

Not in Use

Not in Use Not in Use

Palpitations

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Medtronic Recommends Disabling Non-critical Alerts

Symptom Episode

§ Many patients overutilize the patient assistant for non-cardiac-related events.

§ By enabling the “Symptom + Detected Episode” alert you can disable the Symptom Episode Alert in the majority of the patients.

Maximum Episode Count Met and Maximum Symptom Count Met

§ Both maximum count alerts should only be used at an individual patient level and not at a clinic level.

§ A manual interrogation is required to clear this alert once triggered.

§ This alert should not be used for patients with known AF or who have a history of frequent events.

When new events become non-actionable, consider disabling the CareAlert.

OPTIMIZING CAREALERTS

Disabling Non-actionable CareAlerts

§ Keeping CareAlerts on for all patients can significantly add unnecessary burden to a clinic work flow.

§ A clinic should consider the following questions:

Has a patient encountered a similar alert when no clinical action has been taken?

Example: AF Management patient has intermittent nocturnal Brady and Brady CareAlert is still enabled.

Has the patient been diagnosed?

Example: Cryptogenic Stoke patient has detected AF and is put on anticoagulant medication.

Consider the below reprogramming recommendations when burdened by false episodes.

Undersensing Oversensing Other

Pauses Tachy AF

TWOS

Increase sensitivity (i.e.: 35 µV -> 25 µV)

Increase Pause criteria (i.e.: 3 sec -> 4.5 sec)

Brady

Increase sensitivity (i.e.: 35 µV -> 25 µV)

Increase Brady Detection criteria (i.e.: 4 beats -> 8 beats)

Increase Tachy criteria (i.e.: 16 beats -> 32 beats)

Increase AF detection recording time (i.e.: 6 min to 10 min)

Extend “Sense Threshold Decay Delay” to avoid T-waves

PWOS

Decrease sensitivity if R-wave sensing can be maintained (i.e.: 35 µV -> 50 µV)

Ectopy

Set Ectopy Rejection: “Aggressive”

Decrease AF sensitivity (i.e.: balanced to less)

R-wave Amplitude Undersensing

If distinct R-waves are not marked as VS, consider programming the sensitivity to a more sensitive (lower number) value (for example, from 0.035 to 0.025 mV).

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DEVICE REPROGRAMMING

TROUBLESHOOTING EPISODES

All patient and clinical data displayed on the screenshots are fictitious and for demonstration purposes only.

AF False-positive Detection

Due to ectopy rhythms (i.e., sinus arrhythmia, PACs, PVCs, bigeminy, trigeminy)

T-wave or P-wave Oversensing

If distinct T-waves or P-waves are marked as VS, FS, or TS:

§ For T-waves marked as VS, FS, or TS, consider programming a longer decay delay period.

§ For P-waves marked as VS, FS, or TS, consider programming the sensitivity to a less sensitive (higher number) value.

For false-positive detections, consider one, two, or all three options below:

3Consider programming Ectopy Rejection to “Aggressive.”

Program AT/AF ECG Recording Threshold to a longer ECG.

Consider programming AF Detection to “Less Sensitive” or “Least Sensitive.”

All patient and clinical data displayed on the screenshots are fictitious and for demonstration purposes only.

DEVICE REPROGRAMMING

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The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The MyCareLink Patient Monitor must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

Brief Statement

Reveal LINQ™ LNQ11 Insertable Cardiac Monitor and Patient Assistant

Indications

Reveal LINQ LNQ11 Insertable Cardiac MonitorThe Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and automatically activated monitoring system that records subcutaneous ECG and is indicated in the following cases:§ Patients with clinical syndromes or situations at increased risk of

cardiac arrhythmias§ Patients who experience transient symptoms such as dizziness,

palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia

This device has not been tested specifically for pediatric use.

Patient AssistantThe Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac Monitor to initiate recording of cardiac event data in the implanted device memory.

ContraindicationsThere are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac Monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Warnings/Precautions

Reveal LINQ LNQ11 Insertable Cardiac MonitorPatients with the Reveal LINQ Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radio-frequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual.

Patient AssistantOperation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.

Potential ComplicationsPotential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink™ Network, and CareLink™ Mobile Application

Intended Use The Medtronic MyCareLink Patient Monitor and CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply.

Contraindications There are no known contraindications.

Warnings and Precautions The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic implantable devices.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

medtronic.com

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