6944
Sprint Quattro
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 81 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 99.3 | 97.5 | 95.1 | 95.1 | 95.1 | |||
| # | 356 | 217 | 128 | 85 | 66 | 58 | 50 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 509 |
|---|---|
| Cumulative Months of Follow-Up | 16123 |
| Number of Leads Active in Study | 283 |
6
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Sense | 1 |
| Impedance Out of Range | 1 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 1 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 11 |
| Failure to Sense | 3 |
| Impedance Out of Range | 8 |
| Lead Dislodgement | 16 |
| Oversensing | 11 |
| Unspecified Clinical Failure | 6 |
Distribution Data
| US Market Release | 2000-12-13 |
|---|---|
| CE Approval Date | 1999-11-05 |
| Registered USA Implants | 41390 |
| Estimated Active USA Implants | 21805 |
| US Market Release | 2000-12-13 |
|---|---|
| CE Approval Date | 1999-11-05 |
| Estimated WW Distribution | 83674 |
USA Returned Product Analysis
| Conductor Fracture | 93 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 1 |
| Other | 31 |
WW Returned Product Analysis
| Conductor Fracture | 219 |
|---|---|
| Insulation Breach | 8 |
| Crimp/Weld/Bond | 2 |
| Other | 62 |
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 | TDC |
|---|---|
| Lead Body Diameter | 8.2 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