6943
Sprint
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | at 135 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 97.7 | 96.5 | 95.6 | 93.7 | 92.1 | 90.9 | 89.9 | 87.8 | 86.6 | 83.1 | 83.1 | |||||||||
| # | 1146 | 981 | 874 | 745 | 628 | 511 | 399 | 293 | 196 | 116 | 65 | 53 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1311 |
|---|---|
| Cumulative Months of Follow-Up | 81556 |
| Number of Leads Active in Study | 220 |
94
Qualifying Complications
| Conductor Fracture | 24 |
|---|---|
| Failure to Capture | 8 |
| Failure to Sense | 7 |
| Impedance Out of Range | 8 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 2 |
| Oversensing | 40 |
| Other | 1 |
| Unspecified Clinical Failure | 3 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 1 |
| Failure to Sense | 1 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 1997-10-06 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 20481 |
| Estimated Active USA Implants | 6308 |
| US Market Release | 1997-10-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 31932 |
USA Returned Product Analysis
| Conductor Fracture | 71 |
|---|---|
| Insulation Breach | 28 |
| Crimp/Weld/Bond | 1 |
| Other | 7 |
WW Returned Product Analysis
| Conductor Fracture | 216 |
|---|---|
| Insulation Breach | 82 |
| Crimp/Weld/Bond | 1 |
| Other | 28 |
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 |
| Serial Number Prefix | TCE |
|---|---|
| Lead Body Diameter | 7.8 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of March 12, 2013