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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.2 | 98.9 | 98.4 | 98.0 | 98.0 | |||
| # | 5238 | 4125 | 3152 | 1952 | 1007 | 403 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 6768 |
|---|---|
| Cumulative Months of Follow-Up | 227023 |
| Number of Leads Active in Study | 4044 |
62
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 19 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 13 |
| Failure to Sense | 1 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 15 |
| Oversensing | 2 |
| Other | 2 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 123 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 22 |
| Failure to Capture | 235 |
| Failure to Sense | 72 |
| Impedance Out of Range | 71 |
| Insulation Breach | 2 |
| Lead Dislodgement | 419 |
| Oversensing | 203 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 254918 |
| Estimated Active USA Implants | 235866 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 547896 |
USA Returned Product Analysis
| Conductor Fracture | 391 |
|---|---|
| Insulation Breach | 17 |
| Crimp/Weld/Bond | 0 |
| Other | 64 |
WW Returned Product Analysis
| Conductor Fracture | 682 |
|---|---|
| Insulation Breach | 29 |
| Crimp/Weld/Bond | 0 |
| Other | 98 |
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 October 29, 2020