5071
Screw-in
ALL
Device Survival Probability
5071_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
95.4 | 92.2 | 89.6 | 89.6 | 88.1 | |||||
| # | 193 | 141 | 103 | 72 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 408 |
|---|---|
| Cumulative Months of Follow-Up | 10188 |
| Number of Leads Active in Study | 105 |
25
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 18 |
| 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 | 55 |
| Failure to Sense | 3 |
| Impedance Out of Range | 6 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 51065 |
| Estimated Active USA Implants | 15771 |
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 96911 |
USA Returned Product Analysis
| Conductor Fracture | 20 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 21 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 1 |
| Other | 9 |
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 February 3, 2017