6935M
Sprint Quattro Secure S
ALL
Device Survival Probability
6935M_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | at 54.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.4 | 98.9 | 98.5 | 98.5 | |||||
| # | 3544 | 1945 | 906 | 240 | 77 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 5369 |
|---|---|
| Cumulative Months of Follow-Up | 108397 |
| Number of Leads Active in Study | 3996 |
37
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 9 |
| Failure to Capture | 8 |
| Failure to Sense | 1 |
| Impedance Out of Range | 3 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 12 |
| Oversensing | 1 |
| Other | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 78 |
|---|---|
| Conductor Fracture | 6 |
| Extra Cardiac Stimulation | 11 |
| Failure to Capture | 136 |
| Failure to Sense | 33 |
| Impedance Out of Range | 43 |
| Insulation Breach | 1 |
| Lead Dislodgement | 234 |
| Oversensing | 104 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 160934 |
| Estimated Active USA Implants | 152029 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 343038 |
USA Returned Product Analysis
| Conductor Fracture | 158 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 17 |
WW Returned Product Analysis
| Conductor Fracture | 307 |
|---|---|
| Insulation Breach | 9 |
| Crimp/Weld/Bond | 0 |
| Other | 31 |
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 January 31, 2018