4195
Attain StarFix
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | at 57 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 98.6 | 98.3 | 98.3 | 98.3 | |||||
| # | 723 | 346 | 110 | 59 | 50 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1231 |
|---|---|
| Cumulative Months of Follow-Up | 23520 |
| Number of Leads Active in Study | 963 |
12
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 5 |
| Failure to Capture | 2 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 3 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Extra Cardiac Stimulation | 18 |
|---|---|
| Failure to Capture | 11 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 21 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 2008-08-15 |
|---|---|
| CE Approval Date | 2005-05-13 |
| Registered USA Implants | 14503 |
| Estimated Active USA Implants | 11526 |
| US Market Release | 2008-08-15 |
|---|---|
| CE Approval Date | 2005-05-13 |
| Estimated WW Distribution | 29888 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 2 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 14 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Deployable Lobes |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Cardiac vein |
| Pace/Sense Polarity | Unipolar |
| Serial Number Prefix | AAD |
|---|---|
| Lead Body Diameter | 5.0 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013