4951M
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
| Failure to Capture | 7 |
|---|---|
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1989-07-14 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 5629 |
| Estimated Active USA Implants | 1398 |
| US Market Release | 1989-07-14 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 10284 |
USA Returned Product Analysis
| Conductor Fracture | 19 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 22 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 1 |
| Other | 0 |
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 | LBJ |
|---|---|
| Lead Body Diameter | 4.3 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | None |
Data as of March 12, 2013