6932
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 138 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 98.3 | 98.3 | 98.3 | 97.8 | 97.8 | 97.8 | 96.8 | 96.8 | 96.8 | 93.6 | 93.6 | |||||||||
| # | 356 | 297 | 240 | 199 | 161 | 129 | 110 | 95 | 83 | 69 | 53 | 47 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 412 |
|---|---|
| Cumulative Months of Follow-Up | 25610 |
| Number of Leads Active in Study | 41 |
10
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 2 |
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Oversensing | 4 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Failure to Capture | 2 |
|---|---|
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 4 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 1996-08-06 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 14890 |
| Estimated Active USA Implants | 4289 |
| US Market Release | 1996-08-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 20092 |
USA Returned Product Analysis
| Conductor Fracture | 22 |
|---|---|
| Insulation Breach | 23 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 52 |
|---|---|
| Insulation Breach | 36 |
| Crimp/Weld/Bond | 0 |
| Other | 14 |
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 |
| Serial Number Prefix | TCA |
|---|---|
| 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