6942
Sprint
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 111 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 99.1 | 98.1 | 97.5 | 96.8 | 96.8 | 96.8 | 96.8 | 96.8 | 96.8 |
| # | 294 | 231 | 179 | 141 | 118 | 100 | 78 | 67 | 53 | 49 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 351 |
|---|---|
| Cumulative Months of Follow-Up | 19099 |
| Number of Leads Active in Study | 29 |
7
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Sense | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 3 |
| Unspecified Clinical Failure | 1 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 4 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1997-07-18 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 17679 |
| Estimated Active USA Implants | 5401 |
| US Market Release | 1997-07-18 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 22980 |
USA Returned Product Analysis
| Conductor Fracture | 14 |
|---|---|
| Insulation Breach | 22 |
| Crimp/Weld/Bond | 1 |
| Other | 7 |
WW Returned Product Analysis
| Conductor Fracture | 21 |
|---|---|
| Insulation Breach | 25 |
| Crimp/Weld/Bond | 1 |
| Other | 12 |
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 | Integrated Bipolar |
| Serial Number Prefix | TCB |
|---|---|
| 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