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 | 10 yr | 11 yr | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.2 | 98.9 | 98.6 | 98.4 | 97.9 | 97.3 | 96.4 | 95.4 | 94.6 | 94.6 | ||||||||||
| # | 2314 | 1908 | 1566 | 1259 | 1060 | 912 | 751 | 549 | 321 | 191 | 77 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2817 |
|---|---|
| Cumulative Months of Follow-Up | 145962 |
| Number of Leads Active in Study | 810 |
58
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 21 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 7 |
| Failure to Sense | 1 |
| Impedance Out of Range | 7 |
| Lead Dislodgement | 7 |
| Oversensing | 8 |
| Other | 4 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 26 |
|---|---|
| Conductor Fracture | 4 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 28 |
| Failure to Sense | 14 |
| Impedance Out of Range | 26 |
| Insulation Breach | 1 |
| Lead Dislodgement | 65 |
| Oversensing | 63 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 64170 |
| Estimated Active USA Implants | 37391 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 191217 |
USA Returned Product Analysis
| Conductor Fracture | 414 |
|---|---|
| Insulation Breach | 12 |
| Crimp/Weld/Bond | 0 |
| Other | 42 |
WW Returned Product Analysis
| Conductor Fracture | 796 |
|---|---|
| Insulation Breach | 31 |
| Crimp/Weld/Bond | 0 |
| Other | 77 |
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 December 16, 2021