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 | 10 yr | 11 yr | 12 yr | 13 yr | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.8 | 99.2 | 97.3 | 94.8 | 91.7 | 91.1 | 90.6 | 89.9 | 89.9 | 89.1 | 88.2 | 86.1 | 86.1 | |||||||
| # | 502 | 418 | 352 | 290 | 228 | 192 | 165 | 147 | 132 | 118 | 106 | 91 | 62 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 640 |
|---|---|
| Cumulative Months of Follow-Up | 38786 |
| Number of Leads Active in Study | 63 |
34
Qualifying Complications
| Conductor Fracture | 18 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 1 |
| Impedance Out of Range | 6 |
| Oversensing | 3 |
| Other | 1 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
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 | 44865 |
| Estimated Active USA Implants | 11792 |
| US Market Release | 2000-12-13 |
|---|---|
| CE Approval Date | 1999-11-05 |
| Estimated WW Distribution | 109823 |
USA Returned Product Analysis
| Conductor Fracture | 237 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 1 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 424 |
|---|---|
| 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 20, 2024