4396
Attain Ability Straight
ALL
Device Survival Probability
| at 9 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 45 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 178 |
|---|---|
| Cumulative Months of Follow-Up | 1517 |
| Number of Leads Active in Study | 161 |
0
Qualifying Complications
| Cardiac Perforation | 0 |
|---|---|
| Conductor Fracture | 0 |
| Electrical Abandonment | 0 |
| Extra Cardiac Stimulation | 0 |
| Failure to Capture | 0 |
| Failure to Sense | 0 |
| Impedance Out of Range | 0 |
| Insulation (ESC) | 0 |
| Insulation (MIO) | 0 |
| Insulation (not further defined) | 0 |
| Lead Dislodgement | 0 |
| Medical Judgement | 0 |
| Oversensing | 0 |
| Other | 0 |
| Unspecified Clinical Failure | 0 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 5 |
| Failure to Capture | 2 |
| Lead Dislodgement | 13 |
Distribution Data
| US Market Release | 2011-03-31 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Registered USA Implants | 2803 |
| Estimated Active USA Implants | 2602 |
| US Market Release | 2011-03-31 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Estimated WW Distribution | 7646 |
USA Returned Product Analysis
| Conductor Fracture | |
|---|---|
| Insulation Breach | |
| Crimp/Weld/Bond | |
| Other |
WW Returned Product Analysis
| Conductor Fracture | |
|---|---|
| Insulation Breach | |
| Crimp/Weld/Bond | |
| Other |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | 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 March 12, 2013