4196
Attain Ability
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.3 | 97.5 | 97.0 | |||||||
| # | 1266 | 488 | 61 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1876 |
|---|---|
| Cumulative Months of Follow-Up | 34965 |
| Number of Leads Active in Study | 1300 |
38
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 12 |
| Failure to Capture | 11 |
| Lead Dislodgement | 14 |
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 | 56 |
| Failure to Capture | 34 |
| Impedance Out of Range | 5 |
| Insulation Breach | 1 |
| Lead Dislodgement | 117 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 2009-05-15 |
|---|---|
| CE Approval Date | 2007-07-24 |
| Registered USA Implants | 48556 |
| Estimated Active USA Implants | 40536 |
| US Market Release | 2009-05-15 |
|---|---|
| CE Approval Date | 2007-07-24 |
| Estimated WW Distribution | 96087 |
USA Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 6 |
WW Returned Product Analysis
| Conductor Fracture | 6 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 7 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Double Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Cardiac vein |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | PVI |
|---|---|
| Lead Body Diameter | 4.0 FR |
| Insulation | Polyurethane (outer); SI-polyimide (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013