6948
Sprint Fidelis
ALL
Device Survival Probability
6948_SURV
Loading...
| at 0.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 0 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 40 |
|---|---|
| Cumulative Months of Follow-Up | 2326 |
| Number of Leads Active in Study | 2 |
5
Qualifying Complications
| Conductor Fracture | 4 |
|---|---|
| Impedance Out of Range | 1 |
US Acute Lead Observations
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 7 |
| Lead Dislodgement | 7 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 10381 |
| Estimated Active USA Implants | 1634 |
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 29447 |
USA Returned Product Analysis
| Conductor Fracture | 218 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 6 |
WW Returned Product Analysis
| Conductor Fracture | 557 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
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/Two Coils |
| 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 November 20, 2024