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 | 11 yr | at 138.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.3 | 99.0 | 98.7 | 98.3 | 97.9 | 97.6 | 97.0 | 96.6 | 96.3 | 94.6 | |||||||||
| # | 8384 | 6260 | 4879 | 3972 | 3318 | 2701 | 2138 | 1590 | 919 | 498 | 205 | 78 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 10117 |
|---|---|
| Cumulative Months of Follow-Up | 471812 |
| Number of Leads Active in Study | 2961 |
128
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 59 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 15 |
| Failure to Sense | 1 |
| Impedance Out of Range | 11 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 24 |
| Oversensing | 6 |
| Other | 5 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 226 |
|---|---|
| Conductor Fracture | 24 |
| Extra Cardiac Stimulation | 36 |
| Failure to Capture | 583 |
| Failure to Sense | 198 |
| Impedance Out of Range | 164 |
| Insulation Breach | 3 |
| Lead Dislodgement | 744 |
| Oversensing | 441 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 456809 |
| Estimated Active USA Implants | 377529 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 1075789 |
USA Returned Product Analysis
| Conductor Fracture | 959 |
|---|---|
| Insulation Breach | 41 |
| Crimp/Weld/Bond | 2 |
| Other | 106 |
WW Returned Product Analysis
| Conductor Fracture | 1544 |
|---|---|
| Insulation Breach | 63 |
| Crimp/Weld/Bond | 3 |
| Other | 171 |
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 December 1, 2025