6935
Sprint Quattro Secure
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | at 39 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.2 | 99.2 | 99.2 | ||||||
| # | 846 | 353 | 81 | 44 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1886 |
|---|---|
| Cumulative Months of Follow-Up | 25696 |
| Number of Leads Active in Study | 1610 |
8
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Sense | 1 |
| Lead Dislodgement | 4 |
| Oversensing | 2 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 10 |
|---|---|
| Failure to Capture | 15 |
| Failure to Sense | 5 |
| Impedance Out of Range | 10 |
| Insulation Breach | 1 |
| Lead Dislodgement | 26 |
| Oversensing | 23 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 40213 |
| Estimated Active USA Implants | 36619 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 75996 |
USA Returned Product Analysis
| Conductor Fracture | 46 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 42 |
WW Returned Product Analysis
| Conductor Fracture | 119 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 74 |
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 | TAU |
|---|---|
| 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