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 | at 78.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 99.2 | 98.9 | 98.5 | 98.2 | 97.6 | 97.0 | |||
| # | 2143 | 1704 | 1281 | 803 | 426 | 197 | 108 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2529 |
|---|---|
| Cumulative Months of Follow-Up | 93525 |
| Number of Leads Active in Study | 1171 |
34
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 13 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 2 |
| Failure to Sense | 1 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 7 |
| Oversensing | 6 |
| Other | 1 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 21 |
|---|---|
| Conductor Fracture | 1 |
| Failure to Capture | 20 |
| Failure to Sense | 8 |
| Impedance Out of Range | 17 |
| Insulation Breach | 1 |
| Lead Dislodgement | 42 |
| Oversensing | 49 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 55655 |
| Estimated Active USA Implants | 45235 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 151135 |
USA Returned Product Analysis
| Conductor Fracture | 213 |
|---|---|
| Insulation Breach | 8 |
| Crimp/Weld/Bond | 0 |
| Other | 40 |
WW Returned Product Analysis
| Conductor Fracture | 474 |
|---|---|
| Insulation Breach | 19 |
| Crimp/Weld/Bond | 0 |
| Other | 64 |
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 February 3, 2017