6945
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 141 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 98.7 | 98.2 | 97.6 | 96.8 | 96.1 | 95.6 | 94.5 | 93.2 | 92.7 | 91.7 | 91.7 | |||||||||
| # | 997 | 822 | 684 | 566 | 466 | 382 | 315 | 239 | 183 | 137 | 86 | 49 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1155 |
|---|---|
| Cumulative Months of Follow-Up | 67487 |
| Number of Leads Active in Study | 125 |
38
Qualifying Complications
| Conductor Fracture | 8 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 2 |
| Failure to Sense | 4 |
| Impedance Out of Range | 5 |
| Oversensing | 17 |
| Unspecified Clinical Failure | 1 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 6 |
| Failure to Sense | 2 |
| Insulation Breach | 2 |
| Lead Dislodgement | 4 |
| Oversensing | 7 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 1997-09-26 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 42716 |
| Estimated Active USA Implants | 12821 |
| US Market Release | 1997-09-26 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 51221 |
USA Returned Product Analysis
| Conductor Fracture | 121 |
|---|---|
| Insulation Breach | 35 |
| Crimp/Weld/Bond | 1 |
| Other | 13 |
WW Returned Product Analysis
| Conductor Fracture | 150 |
|---|---|
| Insulation Breach | 43 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
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 | Integrated Bipolar |
| Serial Number Prefix | TDA |
|---|---|
| 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