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The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.
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| Measure | Description | Time Frame |
|---|---|---|
| DF4 Lead Related Complication Rate | To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead | Up to 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Types of DF4 lead related events | Number of DF4 lead related events grouped by type | Up to 5 years |
| Bipolar pacing impedance (ohms) | Summary statistics at 5 years post-implant will be reported. |
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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 DF4 Connector System with a Medtronic DF4 lead. 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 | ||||
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| 5 years |
| High voltage impedance (ohms) | Summary statistics at 5 years post-implant will be reported | 5 years |
| Pacing threshold (volts) | The pacing threshold is the minimum electrical stimulus needed to consistently depolarize the heart outside of the heart's refractory period. Summary statistics at 5 years post-implant will be reported. | 5 years |
| Sensing amplitude (millivolts) | The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant. | 5 years |
| Anchorage |
| Alaska |
| United States |
| Gilbert | Arizona | United States |
| Scottsdale | Arizona | United States |
| Jonesboro | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Bakersfield | California | United States |
| Chula Vista | California | United States |
| Rancho Mirage | California | United States |
| Salinas | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Torrance | California | United States |
| Van Nuys | California | United States |
| Colorado Springs | Colorado | United States |
| Lakewood | Colorado | United States |
| Newark | Delaware | United States |
| Washington D.C. | District of Columbia | United States |
| Bradenton | Florida | United States |
| Clearwater | Florida | United States |
| Albany | Georgia | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Indianapolis | Indiana | United States |
| Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Edgewood | Kentucky | United States |
| Louisville | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Hyattsville | Maryland | United States |
| Takoma Park | Maryland | United States |
| Worcester | Massachusetts | United States |
| Lansing | Michigan | United States |
| Marquette | Michigan | United States |
| Robbinsdale | Minnesota | United States |
| Saint Louis Park | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Columbia | Missouri | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Henderson | Nevada | United States |
| Morristown | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Garden City | New York | United States |
| Huntington | New York | United States |
| New York | New York | United States |
| Poughkeepsie | New York | United States |
| Utica | New York | United States |
| Durham | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Toledo | Ohio | United States |
| Allentown | Pennsylvania | United States |
| Erie | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Plano | Texas | United States |
| The Woodlands | Texas | United States |
| Burlington | Vermont | United States |
| Olympia | Washington | United States |
| Spokane | Washington | United States |
| Tacoma | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Calgary | Alberta | Canada |
| Kingston | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Trois-Rivières | Quebec | Canada |
| Nantes | France |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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