6947
Sprint Quattro Secure
ALL
Device Survival Probability
6947_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 | 15 yr | 16 yr | 17 yr | 18 yr | 19 yr | at 234.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.0 | 98.7 | 98.2 | 97.9 | 97.5 | 97.1 | 96.7 | 96.1 | 95.8 | 95.5 | 95.0 | 94.5 | 94.1 | 92.0 | 92.0 | 90.5 | 88.4 | 87.1 | |
| # | 3302 | 2902 | 2548 | 2259 | 2025 | 1787 | 1541 | 1380 | 1233 | 1073 | 885 | 679 | 514 | 332 | 204 | 146 | 120 | 100 | 78 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4583 |
|---|---|
| Cumulative Months of Follow-Up | 298935 |
| Number of Leads Active in Study | 570 |
105
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 42 |
| Failure to Capture | 8 |
| Failure to Sense | 2 |
| Impedance Out of Range | 13 |
| Insulation (not further defined) | 6 |
| Lead Dislodgement | 5 |
| Oversensing | 21 |
| Other | 4 |
| Unspecified Clinical Failure | 3 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 29 |
|---|---|
| Conductor Fracture | 26 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 83 |
| Failure to Sense | 36 |
| Impedance Out of Range | 61 |
| Insulation Breach | 4 |
| Lead Dislodgement | 124 |
| Oversensing | 141 |
| Unspecified Clinical Failure | 20 |
Distribution Data
| US Market Release | 2001-11-12 |
|---|---|
| CE Approval Date | 2001-10-04 |
| Registered USA Implants | 375589 |
| Estimated Active USA Implants | 125490 |
| US Market Release | 2001-11-12 |
|---|---|
| CE Approval Date | 2001-10-04 |
| Estimated WW Distribution | 617061 |
USA Returned Product Analysis
| Conductor Fracture | 1414 |
|---|---|
| Insulation Breach | 103 |
| Crimp/Weld/Bond | 4 |
| Other | 197 |
WW Returned Product Analysis
| Conductor Fracture | 1749 |
|---|---|
| Insulation Breach | 134 |
| Crimp/Weld/Bond | 4 |
| Other | 239 |
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/Two Coils |
| Serial Number Prefix | TDG |
|---|---|
| Lead Body Diameter | 8.6 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