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 | 14 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 98.9 | 98.6 | 98.5 | 98.1 | 97.5 | 96.8 | 95.9 | 94.8 | 94.6 | 94.3 | 93.2 | 93.2 | |||||||
| # | 2476 | 2022 | 1657 | 1352 | 1152 | 997 | 832 | 702 | 601 | 496 | 376 | 223 | 118 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3023 |
|---|---|
| Cumulative Months of Follow-Up | 172950 |
| Number of Leads Active in Study | 608 |
69
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 26 |
| 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 | 42 |
| Failure to Sense | 16 |
| Impedance Out of Range | 34 |
| Insulation Breach | 1 |
| Lead Dislodgement | 68 |
| Oversensing | 70 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 68869 |
| Estimated Active USA Implants | 40278 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 220288 |
USA Returned Product Analysis
| Conductor Fracture | 492 |
|---|---|
| Insulation Breach | 14 |
| Crimp/Weld/Bond | 0 |
| Other | 44 |
WW Returned Product Analysis
| Conductor Fracture | 893 |
|---|---|
| Insulation Breach | 33 |
| 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 November 20, 2024