Medtronic 126 Addendum

Longevity Projection Update
Software release 1.1 for Medtronic and Vitatron devices InSync® 8040 Legacy® II/Visa Thera® (including i Series™)/Prodigy Thera® DR 7968i
®
Programming guide supplement
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
The following are trademarks of Medtronic: InSync, Medtronic, Prodigy, Thera The following are trademarks of Vitatron: Legacy II, Vitatron

Introduction

The information in this technical literature supplement covers only the features updated by the Longevity Projection Update software release 1.1 and the operation of your updated Medtronic programmer. This information is intended as a supplement to the technical literature supplied with the programmer software for InSync 8040, Legacy II, Thera/Thera-i/Prodigy, and Thera DR 7968i pacemakers.
Instructions for installing the Longevity Projection Update software release 1.1 are covered separately in the software installation instructions provided with the software.
Use the Longevity Projection Update software release 1.1 and this supplement with the InSync 8040, Legacy II, Thera/Thera-i/Prodigy, and Thera DR 7968i pacemaker models listed in the following section, “About the Longevity Projection Update software.”
Refer to the section “About the programmer software” for more information about the programmer software and the corresponding technical literature that covers operation of your programmer.
Refer to the section “Software feature update” for a detailed description of the changes to the longevity feature.

About the Longevity Projection Update software

Installing the Longevity Projection Update software release 1.1 in your programmer updates all previous versions of the software for the devices listed below and the following software applications:
Software model 9980 for InSync 8040 pacemakers.
Software model 9849 for Vitatron Legacy II/Visa pacemakers.
Software model 9879 for Thera/Thera-i/Prodigy pacemakers.
Software model 9847 for Thera DR 7968i pacemakers.
The following pacemaker models will be updated: InSync
8040
Prodigy
D: 7864, 7865, 7866 DR: 7860, 7861, 7862 S: 8164, 8165, 8166 SR: 8158, 8160, 8161, 8162 VDD: 8168
Thera
D: 7944, 7945, 7946, 7964i, 7965i, 7966i DR: 7850, 7851, 7852, 7940, 7941, 7942, 7950, 7951, 7952, 7960i,
7961i, 7962i, 7968i S: 8944, 8945, 8946, 8964i, 8965i, 8966i SR: 8940, 8941, 8942, 8960i, 8961i, 8962i VDD: 8948, 8968i
Vitatron Legacy II
S: 126, 128 SR: 526, 528 D: 726, 728 DR: 826, 828
Longevity Projection Update 3

About the programmer software

This supplement contains information about the update to the longevity estimator function in the software and is intended as an addendum to any previous versions and the following technical literature that you received with the software models 9980, 9849, 9879, and 9847 previously installed in your programmer.
Software model 9980 Device Programming Guide and the Device Reference Guide, used with InSync 8040 pacemakers.
Software model 9849 Pacemaker Information and Programming Guide, used with Vitatron Legacy II/Visa pacemakers.
Software model 9879 Pacemaker Information and Programming Guide, used with Thera/Thera-i/Prodigy pacemakers.
Software model 9847 Pacemaker Information and Programming Guide Supplement, used only with Thera DR 7968i pacemakers.
Note: Although Vitatron Legacy II/Visa software supports all Legacy II and Visa pacemakers, this Longevity Projection Update feature is applicable to Legacy II pacemakers only. The Longevity Projection feature is not supported on Visa pacemakers.

Software feature update

The presentation of “Estimated Time to Replacement” of the device families mentioned in the previous section has been changed to improve the usability and clinical accuracy of the system.
Remaining longevity is a calculated estimate of the time remaining until pacemaker replacement will be required. This calculated estimate is based on the programmed parameter settings and event summary data accumulated by the pacemaker since the previous patient session.
Important: Approximately 5% of patients will reach ERI sooner than the minimum estimate due to battery variation. Elective pacemaker replacement should NOT be based on this estimate. For replacement use only the ERI condition or the battery status “Replace Pacer”.
The representative screen (Figure 1) shows the on-screen explanation of the longevity estimate.
Figure 1. A representative screen showing the on-screen explanation of the longevity estimates.
On the Battery Lead and Data Summary screens the presentation of the “Estimated Time to Replacement” value has changed. It has been updated to show a single average value and a minimum value.
On the Battery Lead Report, Data Summary Report, and the Trace Report the “Estimated Time to Replacement” value has changed. It has been updated to show the average value followed by the minimum value.
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The Strength Duration screen and report will only display the “Estimated Time to Replacement” value.
The following representative programmer screens compare the new presentation (Figure 2) and the previous presentation (Figure 3) of the longevity values on the Battery Lead screen.
Figure 2. A representative Thera/Thera-i/Prodigy Battery Lead screen showing the new presentation of the longevity values (circled in the screen for reference).
Figure 3. A representative Thera/Thera-i/Prodigy Battery Lead screen showing the previous presentation of the longevity values (circled in the screen for reference).
Additionally, the More Info screen displays “Estimated Time to Replacement” using three values: “Maximum”, “Average”, and “Minimum” values in years or in months depending on the longevity of the device.
Longevity Projection Update 5
The representative programmer screens compare the new presentation (Figure 4) and the previous presentation (Figure 5) of the longevity values on the More Info screen.
Figure 4. A representative programmer Thera/Thera-i/Prodigy More Info screen showing the new presentation of the longevity values (circled in the screen for reference).
Figure 5. A representative Thera/Thera-i/Prodigy More Info screen showing the previous presentation of the longevity values (circled in the screen for reference).
The changes to longevity projection feature are the only changes documented in this supplement.
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Medtronic
Manufacturer
Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA www.medtronic.com Tel. +1-763-514-4000 Fax +1-763-514-4879
Medtronic E.C. Authorized Representative/Distributed by
Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668
Canada
Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Tel. 905-826-6020 Fax 905-826-6620
Europe/Africa/Middle East Headquarters
Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland www.medtronic.co.uk Tel. +41-21-802-7000 Fax +41-21-802-7900
Technical manuals: www.medtronic.com/manuals
Vitatron
Vitatron B.V.
P.O. Box 5227 6802 EE Arnhem The Netherlands www.vitatron.com Tel. +31-(0)-26-376-7777 Fax +31-(0)-26-376-7666
Vitatron USA
P.O. Box 59100 Minneapolis, MN 55432 Tel. 1-800-848-2876 Fax +1-763-514-6097
© Medtronic, Inc. 2006 M925461A001B 2006-07-18
*M925461A001*
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