6947
Sprint Quattro Secure
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 117 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.2 | 98.9 | 98.6 | 98.2 | 97.8 | 97.3 | 96.9 | 95.8 | 95.8 |
| # | 2395 | 1900 | 1176 | 745 | 582 | 437 | 327 | 223 | 105 | 48 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 2715 |
|---|---|
| Cumulative Months of Follow-Up | 115003 |
| Number of Leads Active in Study | 1151 |
37
Qualifying Complications
| Conductor Fracture | 7 |
|---|---|
| Failure to Capture | 1 |
| Failure to Sense | 2 |
| Impedance Out of Range | 7 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 4 |
| Oversensing | 11 |
| Unspecified Clinical Failure | 2 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 22 |
|---|---|
| Conductor Fracture | 18 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 66 |
| Failure to Sense | 28 |
| Impedance Out of Range | 45 |
| Insulation Breach | 4 |
| Lead Dislodgement | 99 |
| Oversensing | 109 |
| Unspecified Clinical Failure | 22 |
Distribution Data
| US Market Release | 2001-11-12 |
|---|---|
| CE Approval Date | 2001-10-04 |
| Registered USA Implants | 358933 |
| Estimated Active USA Implants | 243668 |
| US Market Release | 2001-11-12 |
|---|---|
| CE Approval Date | 2001-10-04 |
| Estimated WW Distribution | 469857 |
USA Returned Product Analysis
| Conductor Fracture | 436 |
|---|---|
| Insulation Breach | 32 |
| Crimp/Weld/Bond | 4 |
| Other | 272 |
WW Returned Product Analysis
| Conductor Fracture | 599 |
|---|---|
| Insulation Breach | 46 |
| Crimp/Weld/Bond | 4 |
| Other | 357 |
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 | TDG |
|---|---|
| Lead Body Diameter | 8.6 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