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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.8 | 99.5 | 98.4 | 98.4 | 98.4 | 98.4 | ||||
| # | 366 | 288 | 246 | 194 | 130 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 465 |
|---|---|
| Cumulative Months of Follow-Up | 18414 |
| Number of Leads Active in Study | 186 |
7
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 2 |
| Other | 0 |
Customer 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 | 7989 |
| Estimated Active USA Implants | 6251 |
| US Market Release | 2011-03-31 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Estimated WW Distribution | 28916 |
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 November 8, 2019