6944
Sprint Quattro
ALL
Device Survival Probability
6944_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.8 | 99.2 | 97.3 | 95.0 | 92.1 | 91.5 | 90.8 | 90.8 | |
| # | 529 | 441 | 371 | 299 | 231 | 177 | 134 | 91 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 618 |
|---|---|
| Cumulative Months of Follow-Up | 33100 |
| Number of Leads Active in Study | 131 |
28
Qualifying Complications
| Conductor Fracture | 15 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 1 |
| Impedance Out of Range | 4 |
| Oversensing | 3 |
| Other | 0 |
| Unspecified Clinical Failure | 1 |
US Acute Lead Observations
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 17 |
| Failure to Sense | 3 |
| Impedance Out of Range | 10 |
| Lead Dislodgement | 24 |
| Oversensing | 18 |
| Unspecified Clinical Failure | 6 |
Distribution Data
| US Market Release | 2000-12-13 |
|---|---|
| CE Approval Date | 1999-11-05 |
| Registered USA Implants | 44719 |
| Estimated Active USA Implants | 18781 |
| US Market Release | 2000-12-13 |
|---|---|
| CE Approval Date | 1999-11-05 |
| Estimated WW Distribution | 117671 |
USA Returned Product Analysis
| Conductor Fracture | 203 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 1 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 391 |
|---|---|
| Insulation Breach | 14 |
| Crimp/Weld/Bond | 2 |
| Other | 8 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar/Two Coils |
| Serial Number Prefix | TDC |
|---|---|
| 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 8, 2019