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 | 12 yr | 13 yr | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 98.9 | 98.7 | 98.5 | 98.1 | 97.6 | 96.8 | 95.9 | 94.8 | 94.5 | 94.2 | 92.8 | 92.8 | |||||||
| # | 2443 | 1997 | 1639 | 1342 | 1139 | 980 | 817 | 695 | 587 | 470 | 316 | 178 | 90 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3006 |
|---|---|
| Cumulative Months of Follow-Up | 168788 |
| Number of Leads Active in Study | 671 |
68
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 25 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 8 |
| Failure to Sense | 1 |
| Impedance Out of Range | 8 |
| Lead Dislodgement | 8 |
| Oversensing | 9 |
| Other | 6 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 30 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 39 |
| Failure to Sense | 15 |
| Impedance Out of Range | 30 |
| Insulation Breach | 1 |
| Lead Dislodgement | 68 |
| Oversensing | 68 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 67801 |
| Estimated Active USA Implants | 39612 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 213088 |
USA Returned Product Analysis
| Conductor Fracture | 481 |
|---|---|
| Insulation Breach | 13 |
| Crimp/Weld/Bond | 0 |
| Other | 44 |
WW Returned Product Analysis
| Conductor Fracture | 880 |
|---|---|
| Insulation Breach | 32 |
| Crimp/Weld/Bond | 0 |
| Other | 80 |
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 April 30, 2024