5071
Screw-in
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
97.3 | 94.2 | 92.0 | 92.0 | 90.3 | |||||
| # | 147 | 102 | 75 | 64 | 49 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 295 |
|---|---|
| Cumulative Months of Follow-Up | 8171 |
| Number of Leads Active in Study | 60 |
14
Qualifying Complications
| Failure to Capture | 11 |
|---|---|
| Impedance Out of Range | 1 |
| Oversensing | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 32 |
| Failure to Sense | 2 |
| Impedance Out of Range | 2 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 44319 |
| Estimated Active USA Implants | 15239 |
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 80017 |
USA Returned Product Analysis
| Conductor Fracture | 13 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 14 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 1 |
| Other | 9 |
Product Characteristics
| Lead Type | Epi/Myocardial |
|---|---|
| Type and/or Fixation | Fixed Screw In |
| Lead Function | Pacing/Sensing |
| Lead Placement | Myocardial |
| Lead Tip Location | Myocardial |
| Pace/Sense Polarity | Unipolar |
| Serial Number Prefix | LAQ |
|---|---|
| Lead Body Diameter | 6.6 FR |
| Insulation | Silicon |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | None |
Data as of March 12, 2013