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 | at 78.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.4 | 99.1 | 99.1 | 98.6 | 98.6 | 98.6 | |||
| # | 1401 | 1048 | 739 | 435 | 215 | 100 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1937 |
|---|---|
| Cumulative Months of Follow-Up | 57784 |
| Number of Leads Active in Study | 1188 |
15
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 7 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 6 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 7 |
|---|---|
| Extra Cardiac Stimulation | 99 |
| Failure to Capture | 70 |
| Impedance Out of Range | 11 |
| Lead Dislodgement | 41 |
Distribution Data
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 37966 |
| Estimated Active USA Implants | 30379 |
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 74922 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 7 |
WW Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
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 May 10, 2023