4398
Attain Performa Straight
ALL
Device Survival Probability
4398_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | at 54.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.0 | 99.0 | 97.7 | |||||
| # | 802 | 447 | 210 | 102 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1377 |
|---|---|
| Cumulative Months of Follow-Up | 25935 |
| Number of Leads Active in Study | 1040 |
8
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Impedance Out of Range | 1 |
| Lead Dislodgement | 4 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 6 |
|---|---|
| Extra Cardiac Stimulation | 80 |
| Failure to Capture | 43 |
| Impedance Out of Range | 6 |
| Lead Dislodgement | 34 |
Distribution Data
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 27306 |
| Estimated Active USA Implants | 25351 |
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 52755 |
USA Returned Product Analysis
| Conductor Fracture | 2 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
WW Returned Product Analysis
| Conductor Fracture | 2 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 7 |
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 | Bipolar |
| 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 October 29, 2020