6931
Sprint Fidelis
ALL
Device Survival Probability
6931_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | at 90.0 mo | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.2 | 96.2 | 93.1 | 88.3 | 82.2 | 74.3 | 72.3 | 72.3 | ||
| # | 261 | 232 | 204 | 166 | 137 | 104 | 70 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 311 |
|---|---|
| Cumulative Months of Follow-Up | 18133 |
| Number of Leads Active in Study | 7 |
59
Qualifying Complications
| Conductor Fracture | 36 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Impedance Out of Range | 10 |
| Lead Dislodgement | 2 |
| Oversensing | 7 |
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 1 |
| Failure to Sense | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 3 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 8081 |
| Estimated Active USA Implants | 1161 |
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 27401 |
USA Returned Product Analysis
| Conductor Fracture | 670 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
WW Returned Product Analysis
| Conductor Fracture | 1826 |
|---|---|
| Insulation Breach | 5 |
| Crimp/Weld/Bond | 0 |
| Other | 16 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Active Screw In |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar/One Coil |
| Serial Number Prefix | LFL |
|---|---|
| Lead Body Diameter | 6.6 FR |
| Insulation | Silicone with Polyurethan Overlay |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of November 20, 2024