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The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure. | Patients will be followed for approximately 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients intended to be implanted or are within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 30, 2025 | |
| Reset | Jul 16, 2025 | |
| Release | Oct 23, 2025 |
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| Anchorage |
| Alaska |
| United States |
| Chandler | Arizona | United States |
| Jonesboro | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Bakersfield | California | United States |
| Chula Vista | California | United States |
| La Quinta | California | United States |
| Los Angeles | California | United States |
| Palm Springs | California | United States |
| Rancho Mirage | California | United States |
| Redwood City | California | United States |
| Salinas | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Stanford | California | United States |
| Torrance | California | United States |
| Van Nuys | California | United States |
| Centennial | Colorado | United States |
| Colorado Springs | Colorado | United States |
| Denver | Colorado | United States |
| Lakewood | Colorado | United States |
| New Haven | Connecticut | United States |
| Newark | Delaware | United States |
| Washington D.C. | District of Columbia | United States |
| Bradenton | Florida | United States |
| Clearwater | Florida | United States |
| Davenport | Florida | United States |
| Davie | Florida | United States |
| Jacksonville | Florida | United States |
| Panama City | Florida | United States |
| Safety Harbor | Florida | United States |
| Sebastian | Florida | United States |
| Tampa | Florida | United States |
| Albany | Georgia | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Coeur d'Alene | Idaho | United States |
| Chicago | Illinois | United States |
| Evansville | Indiana | United States |
| Indianapolis | Indiana | United States |
| West Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Edgewood | Kentucky | United States |
| Louisville | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| Clinton | Maryland | United States |
| Hyattsville | Maryland | United States |
| Salisbury | Maryland | United States |
| Silver Spring | Maryland | United States |
| Takoma Park | Maryland | United States |
| Boston | Massachusetts | United States |
| Lansing | Michigan | United States |
| Marquette | Michigan | United States |
| Ypsilanti | Michigan | United States |
| Coon Rapids | Minnesota | United States |
| Minneapolis | Minnesota | United States |
| Robbinsdale | Minnesota | United States |
| Rochester | Minnesota | United States |
| Saint Cloud | Minnesota | United States |
| Saint Louis Park | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Hattiesburg | Mississippi | United States |
| Columbia | Missouri | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Henderson | Nevada | United States |
| Eatontown | New Jersey | United States |
| Morristown | New Jersey | United States |
| Ocean Township | New Jersey | United States |
| Ridgewood | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Bay Shore | New York | United States |
| Garden City | New York | United States |
| Huntington | New York | United States |
| Manhasset | New York | United States |
| New Hyde Park | New York | United States |
| New York | New York | United States |
| Poughkeepsie | New York | United States |
| Staten Island | New York | United States |
| Suffern | New York | United States |
| The Bronx | New York | United States |
| Utica | New York | United States |
| Durham | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Allentown | Pennsylvania | United States |
| Bethlehem | Pennsylvania | United States |
| Danville | Pennsylvania | United States |
| Erie | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Wilkes-Barre | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Plano | Texas | United States |
| San Antonio | Texas | United States |
| The Woodlands | Texas | United States |
| Tyler | Texas | United States |
| Burlington | Vermont | United States |
| Arlington | Virginia | United States |
| Charlottesville | Virginia | United States |
| Falls Church | Virginia | United States |
| Spokane | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Brussels | Belgium |
| Dinant | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Yvoir | Belgium |
| Kingston | Ontario | Canada |
| Sainte-Foy | Quebec | Canada |
| Calgary | Canada |
| Montreal | Canada |
| Ottawa | Canada |
| Trois-Rivières | Canada |
| Kunming | China |
| Taiyuan | China |
| Tianjin | China |
| Copenhagen | Denmark |
| Avignon | France |
| Brest | France |
| Clermont-Ferrand | France |
| Dijon | France |
| La Rochelle | France |
| Metz-Tessy | France |
| Montpellier | France |
| Nantes | France |
| Paris | France |
| Pringy | France |
| Saint-Priest-en-Jarez | France |
| Aachen | Germany |
| Cologne | Germany |
| Essen | Germany |
| Hanover | Germany |
| Homburg | Germany |
| Tübingen | Germany |
| Ulm | Germany |
| Athens | Greece |
| Budapest | Hungary |
| Castrovillari | Italy |
| Lecce | Italy |
| Milan | Italy |
| Udine | Italy |
| Fuchū | Japan |
| Hidaka | Japan |
| Hirosaki | Japan |
| Hiroshima | Japan |
| Kawasaki | Japan |
| Kitakyushu | Japan |
| Kyoto | Japan |
| Ōsaka-sayama | Japan |
| Sapporo | Japan |
| Toyoake | Japan |
| Urasoe | Japan |
| Kuala Lumpur | Malaysia |
| Eindhoven | Netherlands |
| Maastricht | Netherlands |
| Nieuwegein | Netherlands |
| Rotterdam | Netherlands |
| Creixomil | Portugal |
| Belgrade | Serbia |
| Košice | Slovakia |
| Ljubljana | Slovenia |
| Busan | South Korea |
| Changwon | South Korea |
| Daegu | South Korea |
| Gangneung | South Korea |
| Gwangju | South Korea |
| Gyeonggi-do | South Korea |
| Incheon | South Korea |
| Seongnam-si | South Korea |
| Seoul | South Korea |
| A Coruña | Spain |
| Granada | Spain |
| Madrid | Spain |
| Palma de Mallorca | Spain |
| Salamanca | Spain |
| Santa Cruz de Tenerife | Spain |
| Santiago de Compostela | Spain |
| Valencia | Spain |
| Valladolid | Spain |
| Skövde | Sweden |
| Geneva | Switzerland |
| Lausanne | Switzerland |
| Zurich | Switzerland |
| Birmingham | United Kingdom |
| Leicester | United Kingdom |
| Liverpool | United Kingdom |
| Manchester | United Kingdom |
| Middlesbrough | United Kingdom |
| Reset | Nov 6, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2025 | Jul 16, 2025 | |||
| Oct 23, 2025 | Nov 6, 2025 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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