5071
Screw-in
ALL
Device Survival Probability
5071_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
95.4 | 92.3 | 90.3 | 90.3 | 88.4 | 86.3 | ||||
| # | 238 | 181 | 141 | 111 | 81 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 446 |
|---|---|
| Cumulative Months of Follow-Up | 13488 |
| Number of Leads Active in Study | 93 |
31
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 20 |
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 2 |
| Other | 1 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Extra Cardiac Stimulation | 6 |
| Failure to Capture | 82 |
| Failure to Sense | 3 |
| Impedance Out of Range | 7 |
| Lead Dislodgement | 2 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 54075 |
| Estimated Active USA Implants | 16726 |
| US Market Release | 1992-12-03 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 105122 |
USA Returned Product Analysis
| Conductor Fracture | 25 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 26 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 1 |
| Other | 5 |
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 November 8, 2019