4298
Attain Performa
ALL
Device Survival Probability
4298_SURV
Loading...
| 1 yr | 2 yr | at 30.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 98.7 | 97.9 | |||||||
| # | 680 | 201 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1328 |
|---|---|
| Cumulative Months of Follow-Up | 17330 |
| Number of Leads Active in Study | 1102 |
11
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Lead Dislodgement | 10 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 109 |
| Failure to Capture | 54 |
| Impedance Out of Range | 15 |
| Lead Dislodgement | 82 |
Distribution Data
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 45572 |
| Estimated Active USA Implants | 43001 |
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 91285 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 13 |
WW Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 15 |
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 | Bipolar |
| 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 July 31, 2017