CareLink SmartSync™ MRI Access Application SureScan Labeling Supplement
Supported Devices List
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Astra™, Azure™, CareLink Encore™, CareLink SmartSync™, CareLink™, Cobalt™, Crome™, Medtronic CareLink™, Percepta™, Serena™, Solara™, SureScan™
CareLink SmartSync™ MRI Access Application SureScan Labeling Supplement
About this guide
This guide is intended to be used only by health care professionals.
The primary source for MRI SureScan labeling for an implanted device is the MRI technical manual for the implanted device.
There may be multiple programmers that you can use to program SureScan mode for a Medtronic implanted device. Refer to the
appropriate labeling for the programmer and the implanted device for information about device and lead checks, programming
procedures, and algorithms that either you or the programmer must perform when programming SureScan parameters.
This supplemental guide is intended to assist you in locating the instructions for use that are available depending on the implanted
device and the programmer that you are using to program SureScan mode to ON or OFF.
CareLink Model 2090 Programmer or a CareLink Encore Model 29901 Programmer – Refer to the MRI technical manual for the
implanted device’s MRI SureScan labeling and reference information for programming SureScan parameters.
CareLink SmartSync Device Manager Application – Refer to the MRI technical manual for the implanted device’s MRI SureScan
labeling. Refer to the app help for the implanted device’s CareLink SmartSync device application for reference information for
programming SureScan parameters.
CareLink SmartSync MRI Access Application – Refer to the MRI technical manual for the implanted device’s MRI SureScan
labeling for the following topics:
• MRI conditions for use.
• MRI warnings, precautions, and potential adverse events.
• Radiology requirements and considerations.
• Cardiology requirements, and in particular screening to ensure the implanted system meets the following requirements:
– The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
– The device is implanted in the left or the right pectoral region.
• Pre-MRI scan operations, and in particular screening the patient to ensure that the patient does not have additional implanted
cardiac devices.
The MRI app help provides information about device and lead checks and algorithms that are performed by the app to automate the
programming of SureScan parameters. Refer to the MRI app help for labeling related to the following topics:
• Warnings and precautions related to the use of the app and its components.
• Instructions for turning SureScan mode to ON and OFF using the app.
• Additional device and lead checks that are performed by the app.
• Descriptions of algorithms the app uses to program device parameters when turning SureScan mode to ON and OFF.
• Patient monitoring requirements when using the app to turn SureScan mode to ON.
Note: The CareLink SmartSync MRI Access app will automatically perform the necessary device and lead integrity checks when the
device is being programmed using the app. These may include verifying the device status, the electrical integrity of implanted lead
wires connected to the device, as well as relevant implanted device settings. Pre-scan and post-scan tests of the right ventricular (RV)
lead pacing capture threshold (PCT) are not required when using the MRI app to program an implanted device into and out of MRI
SureScan mode.
Refer to Table 1 for information about which programmers can be used to program SureScan parameters for an implanted device.
Then, refer to the section in this guide that describes the applicable MRI SureScan labeling for the programmer you are using.
Note: Only product models that are compatible with the CareLink SmartSync MRI Access application are listed in Table 1.
Note: Specific models may not be available in your geography.
Table 1. Compatible programmers for programming SureScan parameters.
Product name Product model Compatible programmer
Astra DR MRI SureScan X1SR01 Medtronic CareLink Model 2090 Programmer
X1DR01
X2DR01
X3DR01
Astra S SR MRI SureScan X3SR01
Astra XT SR MRI SureScan X2SR01
Medtronic Carelink Encore Model 29901 Programmer
CareLink SmartSync Device Manager Application
CareLink SmartSync MRI Access Application
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Table 1. Compatible programmers for programming SureScan parameters. (continued)
Azure S DR MRI SureScan W3DR01 Medtronic CareLink Model 2090 Programmer
Azure S SR MRI SureScan W2SR01
Azure XT DR MRI SureScan W1DR01
W2DR01
Azure XT SR MRI SureScan W1SR01
W2SR01
Cobalt DR ICD MRI SureScan DDPB3D1 CareLink SmartSync Device Manager Application
DDPB3D4
Cobalt HF CRT-D MRI SureScan DTPB2D1
DTPB2Q1
DTPB2D4
DTPB2QQ
Cobalt VR ICD MRI SureScan DVPB3D1
DVPB3D4
Cobalt XT DR ICD MRI SureScan DDPA2D1
DDPA2D4
Cobalt XT HF CRT-D MRI SureScan DTPA2D1
DTPA2Q1
DTPA2D4
DTPA2QQ
Cobalt XT VR ICD MRI SureScan DVPA2D1
DVPA2D4
Crome DR ICD MRI SureScan DDPC3D1 CareLink SmartSync Device Manager Application
DDPC3D4
Crome HF CRT-D MRI SureScan DTPC2D1
DTPC2Q1
DTPC2D4
DTPC2QQ
Crome VR ICD MRI SureScan DVPC3D1
DVPC3D4
Percepta CRT-P MRI SureScan W1TR01 Medtronic CareLink Model 2090 Programmer
W1TR04
W4TR01
W4TR04
Serena CRT-P MRI SureScan W1TR02 Medtronic CareLink Model 2090 Programmer
W1TR05
W4TR02
W4TR05
Solara CRT-P MRI SureScan W1TR03 Medtronic CareLink Model 2090 Programmer
W1TR06
W4TR03
W4TR06
Medtronic Carelink Encore Model 29901 Programmer
CareLink SmartSync Device Manager Application
CareLink SmartSync MRI Access Application
CareLink SmartSync MRI Access Application
CareLink SmartSync MRI Access Application
Medtronic Carelink Encore Model 29901 Programmer
CareLink SmartSync Device Manager Application
CareLink SmartSync MRI Access Application
Medtronic Carelink Encore Model 29901 Programmer
CareLink SmartSync Device Manager Application
CareLink SmartSync MRI Access Application
Medtronic Carelink Encore Model 29901 Programmer
CareLink SmartSync Device Manager Application
CareLink SmartSync MRI Access Application
4
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M013161C001 A
2021-04-05
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