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 | at 126.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.2 | 99.0 | 98.6 | 98.2 | 97.8 | 97.4 | 97.0 | 96.3 | 95.6 | ||||||||||
| # | 7654 | 5730 | 4571 | 3762 | 3092 | 2475 | 1865 | 1116 | 563 | 234 | 115 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 10085 |
|---|---|
| Cumulative Months of Follow-Up | 424941 |
| Number of Leads Active in Study | 4231 |
119
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 54 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 14 |
| Failure to Sense | 1 |
| Impedance Out of Range | 10 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 23 |
| Oversensing | 5 |
| Other | 5 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 210 |
|---|---|
| Conductor Fracture | 22 |
| Extra Cardiac Stimulation | 34 |
| Failure to Capture | 496 |
| Failure to Sense | 177 |
| Impedance Out of Range | 147 |
| Insulation Breach | 3 |
| Lead Dislodgement | 694 |
| Oversensing | 378 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 414235 |
| Estimated Active USA Implants | 341226 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 965992 |
USA Returned Product Analysis
| Conductor Fracture | 844 |
|---|---|
| Insulation Breach | 37 |
| Crimp/Weld/Bond | 2 |
| Other | 104 |
WW Returned Product Analysis
| Conductor Fracture | 1390 |
|---|---|
| Insulation Breach | 57 |
| Crimp/Weld/Bond | 3 |
| Other | 165 |
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 November 20, 2024