6948
Sprint Fidelis
ALL
Device Survival Probability
| at 0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 30 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 30 |
|---|---|
| Cumulative Months of Follow-Up | 1413 |
| Number of Leads Active in Study | 15 |
0
Qualifying Complications
| Cardiac Perforation | 0 |
|---|---|
| Conductor Fracture | 0 |
| Electrical Abandonment | 0 |
| Extra Cardiac Stimulation | 0 |
| Failure to Capture | 0 |
| Failure to Sense | 0 |
| Impedance Out of Range | 0 |
| Insulation (ESC) | 0 |
| Insulation (MIO) | 0 |
| Insulation (not further defined) | 0 |
| Lead Dislodgement | 0 |
| Medical Judgement | 0 |
| Oversensing | 0 |
| Other | 0 |
| Unspecified Clinical Failure | 0 |
US Acute Lead Observations
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 6 |
| Lead Dislodgement | 7 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 10379 |
| Estimated Active USA Implants | 4911 |
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 22830 |
USA Returned Product Analysis
| Conductor Fracture | 141 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
WW Returned Product Analysis
| Conductor Fracture | 424 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 28 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar |
| Serial Number Prefix | LFH |
|---|---|
| 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