5071
Screw-in
ALL
Device Survival Probability
5071_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | at 66.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
95.5 | 92.0 | 89.7 | 89.7 | 88.5 | 88.5 | ||||
| # | 214 | 158 | 125 | 91 | 63 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 430 |
|---|---|
| Cumulative Months of Follow-Up | 11626 |
| Number of Leads Active in Study | 107 |
28
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 19 |
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 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 | 6 |
| Failure to Capture | 63 |
| Failure to Sense | 3 |
| Impedance Out of Range | 6 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 52663 |
| Estimated Active USA Implants | 16397 |
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 100552 |
USA Returned Product Analysis
| Conductor Fracture | 24 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 25 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 1 |
| Other | 10 |
Product Characteristics
| Lead Type | Epi/Myocardial |
|---|---|
| Type and/or Fixation | Fixed Screw |
| Lead Function | Pacing/Sensing |
| Lead Placement | Myocardial |
| Lead Tip Location | Right Ventricle |
| 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 January 31, 2018