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 | at 102.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 99.2 | 98.9 | 98.6 | 98.4 | 98.0 | 97.1 | 96.1 | 95.5 | |
| # | 2264 | 1830 | 1457 | 1131 | 888 | 571 | 310 | 135 | 75 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2669 |
|---|---|
| Cumulative Months of Follow-Up | 118629 |
| Number of Leads Active in Study | 954 |
44
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 17 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 4 |
| Failure to Sense | 1 |
| Impedance Out of Range | 5 |
| Lead Dislodgement | 7 |
| Oversensing | 6 |
| Other | 1 |
| Unspecified Clinical Failure | 1 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 22 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 24 |
| Failure to Sense | 8 |
| Impedance Out of Range | 18 |
| Insulation Breach | 1 |
| Lead Dislodgement | 56 |
| Oversensing | 57 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 59666 |
| Estimated Active USA Implants | 47374 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 168448 |
USA Returned Product Analysis
| Conductor Fracture | 312 |
|---|---|
| Insulation Breach | 9 |
| Crimp/Weld/Bond | 0 |
| Other | 41 |
WW Returned Product Analysis
| Conductor Fracture | 652 |
|---|---|
| Insulation Breach | 25 |
| Crimp/Weld/Bond | 0 |
| Other | 69 |
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 11, 2019