6949
Sprint Fidelis
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 81 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.7 | 96.9 | 94.2 | 92.4 | 89.4 | 84.2 | 81.0 | |||
| # | 706 | 612 | 505 | 377 | 263 | 125 | 57 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 795 |
|---|---|
| Cumulative Months of Follow-Up | 37326 |
| Number of Leads Active in Study | 241 |
75
Qualifying Complications
| Conductor Fracture | 36 |
|---|---|
| Failure to Capture | 2 |
| Failure to Sense | 4 |
| Impedance Out of Range | 14 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 1 |
| Oversensing | 15 |
| Unspecified Clinical Failure | 1 |
US Acute Lead Observations
| Cardiac Perforation | 10 |
|---|---|
| Conductor Fracture | 40 |
| Failure to Capture | 32 |
| Failure to Sense | 19 |
| Impedance Out of Range | 17 |
| Insulation Breach | 6 |
| Lead Dislodgement | 23 |
| Oversensing | 30 |
| Unspecified Clinical Failure | 25 |
Distribution Data
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 186691 |
| Estimated Active USA Implants | 79598 |
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 220718 |
USA Returned Product Analysis
| Conductor Fracture | 5977 |
|---|---|
| Insulation Breach | 29 |
| Crimp/Weld/Bond | 3 |
| Other | 196 |
WW Returned Product Analysis
| Conductor Fracture | 7041 |
|---|---|
| Insulation Breach | 34 |
| Crimp/Weld/Bond | 3 |
| Other | 256 |
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 | LFJ |
|---|---|
| Lead Body Diameter | 6.6 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of March 12, 2013