4951
Spectraflex
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
97.7 | 96.5 | 93.8 | 90.5 | ||||||
| # | 89 | 75 | 61 | 51 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 179 |
|---|---|
| Cumulative Months of Follow-Up | 5953 |
| Number of Leads Active in Study | 4 |
14
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 7 |
| Failure to Sense | 3 |
| Impedance Out of Range | 1 |
| Insulation (ESC) | 1 |
| Insulation (not further defined) | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 1 |
Distribution Data
| US Market Release | 1981-10-01 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 6027 |
| Estimated Active USA Implants | 1134 |
| US Market Release | 1981-10-01 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 7226 |
USA Returned Product Analysis
| Conductor Fracture | 17 |
|---|---|
| Insulation Breach | 8 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
WW Returned Product Analysis
| Conductor Fracture | 28 |
|---|---|
| Insulation Breach | 17 |
| Crimp/Weld/Bond | 0 |
| Other | 12 |
Product Characteristics
| Lead Type | Epi/Myocardial |
|---|---|
| Type and/or Fixation | Stab-in Barb |
| Lead Function | Pacing/Sensing |
| Lead Placement | Myocardial |
| Lead Tip Location | Myocardial |
| Pace/Sense Polarity | Unipolar |
| Serial Number Prefix | TF |
|---|---|
| Lead Body Diameter | 3.8 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | 5 mm |
| High Voltage Connector | n/a |
| Steroid | None |
Data as of March 12, 2013