6931
Sprint Fidelis
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | at 66 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.2 | 96.2 | 93.0 | 89.2 | 83.8 | 81.6 | ||||
| # | 257 | 226 | 192 | 139 | 85 | 47 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 294 |
|---|---|
| Cumulative Months of Follow-Up | 13106 |
| Number of Leads Active in Study | 119 |
37
Qualifying Complications
| Conductor Fracture | 19 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Impedance Out of Range | 7 |
| Lead Dislodgement | 2 |
| Oversensing | 5 |
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 | 8079 |
| Estimated Active USA Implants | 3633 |
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 19802 |
USA Returned Product Analysis
| Conductor Fracture | 504 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 1499 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 27 |
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 |
| 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 March 12, 2013