4298
Attain Performa
ALL
Device Survival Probability
4298_SURV
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| 1 yr | 2 yr | 3 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 98.9 | 98.5 | |||||||
| # | 855 | 371 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1435 |
|---|---|
| Cumulative Months of Follow-Up | 22963 |
| Number of Leads Active in Study | 1143 |
12
Qualifying Complications
| Extra Cardiac Stimulation | 2 |
|---|---|
| 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 | 3 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 120 |
| Failure to Capture | 64 |
| Impedance Out of Range | 16 |
| Lead Dislodgement | 98 |
Distribution Data
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 52266 |
| Estimated Active USA Implants | 49297 |
| US Market Release | 2014-08-01 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 103460 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 14 |
WW Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 16 |
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 January 31, 2018