4298
Attain Performa
ALL
Device Survival Probability
4298_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 98.7 | 98.6 | 98.6 | 98.4 | 98.2 | 98.2 | 98.2 | 98.2 | |
| # | 1893 | 1612 | 1372 | 1155 | 887 | 654 | 450 | 249 | 77 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2271 |
|---|---|
| Cumulative Months of Follow-Up | 112894 |
| Number of Leads Active in Study | 617 |
29
Qualifying Complications
| Extra Cardiac Stimulation | 5 |
|---|---|
| Failure to Capture | 5 |
| Lead Dislodgement | 16 |
| Other | 3 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 7 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 244 |
| Failure to Capture | 172 |
| Failure to Sense | 1 |
| Impedance Out of Range | 46 |
| Lead Dislodgement | 265 |
Distribution Data
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 123082 |
| Estimated Active USA Implants | 94914 |
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 268358 |
USA Returned Product Analysis
| Conductor Fracture | 7 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 27 |
WW Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 31 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Double Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Quadripolar |
| Serial Number Prefix | QUA |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-4 |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of November 20, 2024