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 | 7 yr | 8 yr | 9 yr | 10 yr | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.5 | 99.2 | 99.0 | 98.6 | 98.2 | 97.7 | 97.3 | 96.8 | 96.8 |
| # | 7128 | 5483 | 4436 | 3648 | 2963 | 2343 | 1589 | 846 | 390 | 126 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 9745 |
|---|---|
| Cumulative Months of Follow-Up | 396299 |
| Number of Leads Active in Study | 4568 |
111
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 50 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 14 |
| Failure to Sense | 1 |
| Impedance Out of Range | 10 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 20 |
| Oversensing | 5 |
| Other | 4 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 190 |
|---|---|
| Conductor Fracture | 22 |
| Extra Cardiac Stimulation | 32 |
| Failure to Capture | 453 |
| Failure to Sense | 153 |
| Impedance Out of Range | 130 |
| Insulation Breach | 3 |
| Lead Dislodgement | 663 |
| Oversensing | 350 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 390619 |
| Estimated Active USA Implants | 320954 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 902508 |
USA Returned Product Analysis
| Conductor Fracture | 785 |
|---|---|
| Insulation Breach | 35 |
| Crimp/Weld/Bond | 2 |
| Other | 102 |
WW Returned Product Analysis
| Conductor Fracture | 1302 |
|---|---|
| Insulation Breach | 52 |
| Crimp/Weld/Bond | 3 |
| Other | 161 |
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 30, 2024