4298
Attain Performa
ALL
Device Survival Probability
4298_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | at 54.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.3 | 98.9 | 98.8 | 98.8 | 98.8 | |||||
| # | 1266 | 875 | 513 | 158 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2031 |
|---|---|
| Cumulative Months of Follow-Up | 44080 |
| Number of Leads Active in Study | 1473 |
16
Qualifying Complications
| Extra Cardiac Stimulation | 4 |
|---|---|
| Failure to Capture | 0 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 11 |
| Other | 1 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 5 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 170 |
| Failure to Capture | 93 |
| Failure to Sense | 1 |
| Impedance Out of Range | 23 |
| Lead Dislodgement | 148 |
Distribution Data
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 75801 |
| Estimated Active USA Implants | 70622 |
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 149230 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 15 |
WW Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 17 |
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 November 8, 2019