6935M
Sprint Quattro Secure S
ALL
Device Survival Probability
6935M_SURV
Loading...
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | at 66.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.1 | 98.9 | 98.7 | 97.7 | ||||
| # | 4482 | 3071 | 1700 | 781 | 226 | 83 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 5914 |
|---|---|
| Cumulative Months of Follow-Up | 154758 |
| Number of Leads Active in Study | 3967 |
42
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 10 |
| Failure to Capture | 10 |
| Failure to Sense | 1 |
| Impedance Out of Range | 3 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 12 |
| Oversensing | 2 |
| Other | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 93 |
|---|---|
| Conductor Fracture | 7 |
| Extra Cardiac Stimulation | 15 |
| Failure to Capture | 170 |
| Failure to Sense | 47 |
| Impedance Out of Range | 49 |
| Insulation Breach | 1 |
| Lead Dislodgement | 291 |
| Oversensing | 147 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 198468 |
| Estimated Active USA Implants | 187121 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 428349 |
USA Returned Product Analysis
| Conductor Fracture | 261 |
|---|---|
| Insulation Breach | 11 |
| Crimp/Weld/Bond | 0 |
| Other | 35 |
WW Returned Product Analysis
| Conductor Fracture | 480 |
|---|---|
| Insulation Breach | 19 |
| Crimp/Weld/Bond | 0 |
| Other | 57 |
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 April 11, 2019