4296
Attain Ability Plus
ALL
Device Survival Probability
| at 9 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | |||||||||
| # | 87 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 672 |
|---|---|
| Cumulative Months of Follow-Up | 2876 |
| Number of Leads Active in Study | 618 |
2
Qualifying Complications
| Lead Dislodgement | 2 |
|---|
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Extra Cardiac Stimulation | 8 |
|---|---|
| Failure to Capture | 5 |
| Insulation Breach | 1 |
| Lead Dislodgement | 35 |
Distribution Data
| US Market Release | 2011-04-01 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Registered USA Implants | 12038 |
| Estimated Active USA Implants | 11344 |
| US Market Release | 2011-04-01 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Estimated WW Distribution | 27577 |
USA Returned Product Analysis
| Conductor Fracture | |
|---|---|
| Insulation Breach | |
| Crimp/Weld/Bond | |
| Other |
WW Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Distal Double Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Cardiac vein |
| Pace/Sense Polarity | Dual Electrodes |
| Serial Number Prefix | RRA |
|---|---|
| Lead Body Diameter | 5.3 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