4396
Attain Ability Straight
ALL
Device Survival Probability
4396_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 78.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.8 | 99.2 | 98.1 | 98.1 | 98.1 | 98.1 | 98.1 | |||
| # | 369 | 292 | 252 | 208 | 151 | 83 | 57 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 465 |
|---|---|
| Cumulative Months of Follow-Up | 19388 |
| Number of Leads Active in Study | 174 |
8
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 4 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 2 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 19 |
| Failure to Capture | 10 |
| Lead Dislodgement | 34 |
Distribution Data
| US Market Release | 2011-03-31 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Registered USA Implants | 8067 |
| Estimated Active USA Implants | 6135 |
| US Market Release | 2011-03-31 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Estimated WW Distribution | 29402 |
USA Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 6 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
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 | Dual Electrodes |
| Serial Number Prefix | RAE |
|---|---|
| Lead Body Diameter | 4.0 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of April 10, 2020