4193
Attain OTW
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 99 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
95.9 | 95.0 | 94.3 | 94.3 | 93.8 | 93.3 | 93.3 | 92.3 | 92.3 | |
| # | 545 | 437 | 358 | 275 | 203 | 145 | 99 | 57 | 44 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 675 |
|---|---|
| Cumulative Months of Follow-Up | 30442 |
| Number of Leads Active in Study | 123 |
38
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 8 |
| Failure to Capture | 12 |
| Lead Dislodgement | 14 |
| Unspecified Clinical Failure | 3 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Extra Cardiac Stimulation | 16 |
|---|---|
| Failure to Capture | 11 |
| Lead Dislodgement | 44 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2002-05-03 |
|---|---|
| CE Approval Date | 2000-12-22 |
| Registered USA Implants | 100672 |
| Estimated Active USA Implants | 34954 |
| US Market Release | 2002-05-03 |
|---|---|
| CE Approval Date | 2000-12-22 |
| Estimated WW Distribution | 174617 |
USA Returned Product Analysis
| Conductor Fracture | 52 |
|---|---|
| Insulation Breach | 8 |
| Crimp/Weld/Bond | 0 |
| Other | 51 |
WW Returned Product Analysis
| Conductor Fracture | 58 |
|---|---|
| Insulation Breach | 8 |
| Crimp/Weld/Bond | 0 |
| Other | 108 |
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 | Unipolar |
| Serial Number Prefix | BAA |
|---|---|
| Lead Body Diameter | 4.0 FR |
| Insulation | Polyurethane (55D) |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013