5.3.1. Transmission Report

5.3.1.1. Overview

The data retrieved from the implanted devices allowing wireless communication are checked, analyzed and presented in a report for review by the patient’s following physician.

The transmission report has been designed to provide a synthesized view of the main technical and diagnostic data in order to evaluate the functioning status of the implanted cardiac device and the patient's health condition.

The transmission report is provided as a PDF on the website on the NEW TRANSMISSONS, NEW EVENTS, and/or NEW FOLLOW UPS pages and can be printed. You can also export the report in PDF onto your computer, using the Save icon available in Acrobat Reader or select Save a Copy from the File drop-down menu. Browse the possible locations on your PC or the network where you can save a copy of a document. Click on the Save button.

5.3.1.2. Header

The header provides patient and device information:

• patient's name and date of birth 
• current device implant date
• device family, model and serial number

5.3.1.3. Footer

The footer provides the following information:

• Report processing date and time
• the confidential patient information statement
• page number over total number of pages
• report software version
• implanted device software version

5.3.1.4. Title of Report

The title provides the following information:

Report type

Alert report

For alert conditions that are enabled the report may include the following:

• an active alert condition occurred and triggered a transmission 
• alert condition occurred and is included in a PIT (Patient Initiated Transmission) or scheduled transmission

Follow up

Scheduled transmission

Patient initiated transmission (PIT)

transmitted manually by the patient

Date sent

Date of transmission from the implantable device to the monitoring device

Time sent

Time of transmission from the implantable device to the monitoring device

If the report generation is delayed more than 24 hours following the communication between the implanted device and the monitoring device, the title will include the following indicators:

• Sent: the date-time of transmission from the device to the monitoring device
• Received: date-time referring to the report's availability

The devices allowing wireless transmissions are programmed to automatically detect conditions outside of alert parameter settings. When an event occurs that meets the alert conditions, an alert report is transmitted, usually during the following evening.

If the implanted device detects more than one event, the title will display the message "Several alerts raised" and all the events will be reported in the Warnings section.

5.3.1.5. Overview

The top panel is an overview of the device activity since the previous report, presented in 4 different categories: Statistics, Device Management, Warnings and Observations.

5.3.1.5.1. Statistics

Arrhythmia History

Displays ventricular and atrial events:

• Events: some episodes have been detected
• No events: no events have been detected

5.3.1.5.2. Device Management

Device management provides 2 significant indicators regarding battery status and leads impedance status. See color codes for status below.

Battery

• OK: normal
• Red: indicates RRT (Recommended Replacement Time)* condition has been reached

*: corresponds to the previously used Elective Replacement Indicator (ERI). The indicator will display a message “<3 months” or “<12 months” for pacemakers when the remaining longevity can be calculated and is close to the Recommended Replacement Time.

Leads

For each patient, a normal impedance range is programmed with a high level and a low level threshold for each lead. Programming must be done by the programmer during the in-office follow up and is only possible if alert transmissions are enabled. Otherwise, values will be compared with the default normal range (values between 200 ohms and 3000 ohms).

Lead status is evaluated comparing the impedance measurement performed with the normal impedance range programmed. Lead status is displayed according to the color codes described below. The warning section will display a specific message when more information is available.

• OK:
  • Normal lead impedance conditions
• Red:
  • An alert condition related to lead measurement was detected since the previous remote monitoring transmission.
  • The last impedance measurement for a specific lead was out of the normal range. Last measurement is displayed in the Device Management Summary and in Device Management section.
  • Warning on current low P wave measurement
• Yellow:
  • An alert condition related to lead measurement was detected before the previous transmission and therefore already displayed in an older patient report.
  • No impedance measurements have been performed for at least one lead after the previous transmission and no data are available to evaluate the lead condition.
  • No P wave amplitude measurement since the previous transmission
  • No R wave amplitude measurement since the previous transmission

5.3.1.5.3. Warnings

The warning section highlights specific findings that are considered critical for the proper functioning of the device and for the patient. The data retrieved from the implanted device are screened to automatically detect conditions outside of pre-defined parameter boundaries. When an event occurs that meets the alert conditions, a warning is displayed.

If no warning conditions are detected, the section will display the message: "No warning detected".

If the list of messages is too long, the list is truncated and indicates the total number of warnings.

5.3.1.5.4. Observations

This section highlights either alerts issued by the device or diagnostics resulting from the data interpretation, with the purpose of pointing out aspects useful for the diagnosis.

The messages in this section could be related to:

• MRI Information (mode deactivated or Programmed)
• Clinical Alert conditions (AT/AF burden, Fast V rate during AT/AF, Sleep Apnea, Asynchronous mode)
• AIDA Observations (Number of fallback, time spent in Mode Switch, Ventricular Rate during Mode Switch, SafeR diagnostic, AVD reprogramming).

If no Observation conditions are detected, the section will display the message: "No observation was detected".

5.3.2. Therapies summary

Brady therapies

The brady therapies table provides the values of the following programmed brady parameters:

• Pacing mode
• AV delay at rest and in exercise
• AV delay offset
• Atrial and Ventricular sensitivity
• Atrial and Ventricular lead sensing polarity

The table also provides brady therapy statistics since the last reset:

• For each Lead:
  • Percentage of pacing in Rate Response (RR)
  • Percentage of pacing (Pace)
  • Percentage of sensing (Sens.)
• Mode switch activity:
  • Number of Mode Switches
  • Total Time in Mode Switch
  • PMT (Pacemaker Mediated Tachycardia)

5.3.3. Device Management Summary

5.3.3.1. Battery

Overview color indicator:

• OK: normal. The battery measurements display values within normal range.
• Red: indicates Recommended Replacement Time (RRT)* condition has been reached.

The indicator will display a message “<3 months” or “<12 months” when the remaining longevity can be calculated and is close to the Recommended Replacement Time.

*: corresponds to previously used Elective Replacement Indicator (ERI).

Battery information:

• Last Battery voltage measurement
• Time to RRT: estimated time to reach the Recommended Replacement Time.

5.3.3.2. Leads

Overview color indicator:

Lead status is evaluated comparing the impedance measurement performed to a predefined range (values between 200 ohms and 3000 ohms). Lead status is displayed according to the color codes described below. The warning section will display a specific message when more information is available.

• OK: normal lead impedance conditions. Impedance for all leads is measured within normal range (values between 200 ohms and 3000 ohms).
• Red: The last impedance measurement of at least one of the leads is out of the predefined range (200 ohms-3000 ohms). Look at the impedance measurements to see which leads are concerned.
• Unknown: This status is displayed if there are no data available to evaluate the lead condition: for instance no lead impedance measurement was performed since last reset of the implanted device memories.

The table provides the main information related to each lead:

• Impedance (ohms): the last impedance measurements (performed every six hours) for each lead:
  • A
  • RV
• Detection (mV): the last endocardial wave amplitude measurements performed beat-to-beat in millivolts:
  • P wave amplitude for atrial channel
  • R wave amplitude for right ventricular channel
• Threshold (V): Pacing Threshold values stored in the implanted device (in Volts):
  • Atrial: Last manual Pacing Threshold executed with the programmer or last Automatic Threshold executed by the device if RAAT algorithm is active.
  • Right Ventricular: Last manual Pacing Threshold executed with the programmer or last Automatic Threshold executed by the device if RVAT algorithm is active.
  • Left Ventricular: Last manual Pacing Threshold executed with the programmer.

For each display:

• The measurement date is added when available
• For impedance measurement out of the programmed normal range (200 – 3000 ohms), the value is highlighted “≤200” or “>3000 ohms”

Impedance graphs for each lead:

• Impedance: 6 month trend of the lead impedance plotted by the daily mean value

5.3.3.3. Real Time EGM

Provides a 7 second EGM strip automatically recorded during the data transmission from the implanted device to the monitor.

The strip shows Atrial and RV channel EGM records and the associated marker chain.