4398
Attain Performa Straight
ALL
Device Survival Probability
4398_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | at 90.0 mo | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.6 | 99.3 | 99.0 | 98.8 | 98.8 | 98.1 | 98.1 | ||
| # | 1678 | 1315 | 995 | 725 | 467 | 239 | 108 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2132 |
|---|---|
| Cumulative Months of Follow-Up | 78542 |
| Number of Leads Active in Study | 1101 |
17
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 7 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 8 |
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 | 111 |
| Failure to Capture | 81 |
| Impedance Out of Range | 13 |
| Lead Dislodgement | 44 |
Distribution Data
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 42676 |
| Estimated Active USA Implants | 33971 |
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 84478 |
USA Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 7 |
WW Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Quadripolar |
| Serial Number Prefix | QUB |
|---|---|
| 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