6935M
Sprint Quattro Secure S
ALL
Device Survival Probability
6935M_SURV
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| 1 yr | 2 yr | 3 yr | at 42.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.4 | 99.1 | 99.1 | ||||||
| # | 2280 | 997 | 276 | 89 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4616 |
|---|---|
| Cumulative Months of Follow-Up | 63880 |
| Number of Leads Active in Study | 3804 |
19
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 4 |
| Failure to Capture | 4 |
| Impedance Out of Range | 1 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 7 |
| Oversensing | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
- There are no performance notes for this model.
US Acute Lead Observations
| Cardiac Perforation | 50 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 8 |
| Failure to Capture | 105 |
| Failure to Sense | 17 |
| Impedance Out of Range | 29 |
| Insulation Breach | 1 |
| Lead Dislodgement | 152 |
| Oversensing | 75 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 114336 |
| Estimated Active USA Implants | 108393 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 246452 |
USA Returned Product Analysis
| Conductor Fracture | 84 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 9 |
WW Returned Product Analysis
| Conductor Fracture | 157 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 20 |
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 February 3, 2017