6935M
Sprint Quattro Secure S
ALL
Device Survival Probability
6935M_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.2 | 99.0 | 98.9 | 98.0 | ||||
| # | 4709 | 3565 | 2193 | 1110 | 432 | 69 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 6331 |
|---|---|
| Cumulative Months of Follow-Up | 179033 |
| Number of Leads Active in Study | 4140 |
45
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 10 |
| Failure to Sense | 1 |
| Impedance Out of Range | 3 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 13 |
| Oversensing | 2 |
| Other | 1 |
US Acute Lead Observations
| Cardiac Perforation | 104 |
|---|---|
| Conductor Fracture | 7 |
| Extra Cardiac Stimulation | 19 |
| Failure to Capture | 200 |
| Failure to Sense | 57 |
| Impedance Out of Range | 55 |
| Insulation Breach | 1 |
| Lead Dislodgement | 337 |
| Oversensing | 167 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 221049 |
| Estimated Active USA Implants | 207090 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 479501 |
USA Returned Product Analysis
| Conductor Fracture | 318 |
|---|---|
| Insulation Breach | 13 |
| Crimp/Weld/Bond | 0 |
| Other | 48 |
WW Returned Product Analysis
| Conductor Fracture | 562 |
|---|---|
| Insulation Breach | 23 |
| Crimp/Weld/Bond | 0 |
| Other | 78 |
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/One Coil |
| Serial Number Prefix | TDL |
|---|---|
| Lead Body Diameter | 2.8 mm (8.4 Fr) |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | DF4-LLHO |
| High Voltage Connector | DF4-LLHO |
| Steroid | Yes |
Data as of November 8, 2019