4194
Attain OTW
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 75 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.7 | 97.7 | 97.7 | 97.4 | 96.8 | 94.2 | 94.2 | |||
| # | 934 | 611 | 372 | 222 | 141 | 68 | 52 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1222 |
|---|---|
| Cumulative Months of Follow-Up | 36808 |
| Number of Leads Active in Study | 731 |
28
Qualifying Complications
| Extra Cardiac Stimulation | 4 |
|---|---|
| Failure to Capture | 7 |
| Insulation (ESC) | 1 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 14 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 28 |
| Failure to Capture | 34 |
| Impedance Out of Range | 6 |
| Lead Dislodgement | 114 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Registered USA Implants | 108173 |
| Estimated Active USA Implants | 64822 |
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Estimated WW Distribution | 187459 |
USA Returned Product Analysis
| Conductor Fracture | 12 |
|---|---|
| Insulation Breach | 53 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
WW Returned Product Analysis
| Conductor Fracture | 13 |
|---|---|
| Insulation Breach | 55 |
| Crimp/Weld/Bond | 0 |
| Other | 25 |
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 | Bipolar |
| Serial Number Prefix | LFG |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Polyurethane (55D) outer; silicone inner |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013