6935
Sprint Quattro Secure S
ALL
Device Survival Probability
6935_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 99.2 | 99.0 | 98.6 | 98.5 | 98.0 | 97.3 | 96.6 | 95.0 | |
| # | 2309 | 1856 | 1479 | 1153 | 930 | 687 | 416 | 205 | 71 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2712 |
|---|---|
| Cumulative Months of Follow-Up | 124683 |
| Number of Leads Active in Study | 918 |
46
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 17 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 5 |
| Failure to Sense | 1 |
| Impedance Out of Range | 5 |
| Lead Dislodgement | 7 |
| Oversensing | 7 |
| Other | 1 |
| Unspecified Clinical Failure | 1 |
US Acute Lead Observations
| Cardiac Perforation | 24 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 27 |
| Failure to Sense | 9 |
| Impedance Out of Range | 24 |
| Insulation Breach | 1 |
| Lead Dislodgement | 57 |
| Oversensing | 61 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 60635 |
| Estimated Active USA Implants | 47415 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 173235 |
USA Returned Product Analysis
| Conductor Fracture | 339 |
|---|---|
| Insulation Breach | 11 |
| Crimp/Weld/Bond | 0 |
| Other | 41 |
WW Returned Product Analysis
| Conductor Fracture | 690 |
|---|---|
| Insulation Breach | 28 |
| Crimp/Weld/Bond | 0 |
| Other | 70 |
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 | TAU |
|---|---|
| Lead Body Diameter | 8,2 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of November 8, 2019