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 | 10 yr | at 126.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 98.7 | 98.5 | 98.5 | 98.2 | 98.1 | 98.1 | 98.1 | 98.1 | 98.1 | 98.1 | ||||||||||
| # | 1910 | 1630 | 1394 | 1176 | 964 | 766 | 557 | 404 | 248 | 105 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2284 |
|---|---|
| Cumulative Months of Follow-Up | 122595 |
| Number of Leads Active in Study | 462 |
32
Qualifying Complications
| Extra Cardiac Stimulation | 5 |
|---|---|
| Failure to Capture | 6 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 16 |
| Other | 4 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 8 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 253 |
| Failure to Capture | 206 |
| Failure to Sense | 1 |
| Impedance Out of Range | 57 |
| Lead Dislodgement | 284 |
Distribution Data
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 133379 |
| Estimated Active USA Implants | 102520 |
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 299961 |
USA Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 27 |
WW Returned Product Analysis
| Conductor Fracture | 12 |
|---|---|
| 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) SI-polyimide (SI-PI)(inner) |
| Pace/Sense Connector Style | IS-4 |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of June 8, 2026