4195
Attain StarFix
ALL
Device Survival Probability
4195_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 98.6 | 98.3 | 97.8 | 97.3 | 96.9 | 96.4 | 95.7 | 95.1 | |
| # | 1270 | 1087 | 922 | 734 | 578 | 415 | 278 | 153 | 62 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1486 |
|---|---|
| Cumulative Months of Follow-Up | 75048 |
| Number of Leads Active in Study | 352 |
36
Qualifying Complications
| Conductor Fracture | 4 |
|---|---|
| Extra Cardiac Stimulation | 13 |
| Failure to Capture | 7 |
| Impedance Out of Range | 2 |
| Insulation (not further defined) | 5 |
| Lead Dislodgement | 5 |
| Other | 0 |
Customer Communications For This Model
US Acute Lead Observations
| Extra Cardiac Stimulation | 29 |
|---|---|
| Failure to Capture | 21 |
| Impedance Out of Range | 4 |
| Lead Dislodgement | 29 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 2008-08-15 |
|---|---|
| CE Approval Date | 2005-05-13 |
| Registered USA Implants | 17404 |
| Estimated Active USA Implants | 10662 |
| US Market Release | 2008-08-15 |
|---|---|
| CE Approval Date | 2005-05-13 |
| Estimated WW Distribution | 44374 |
USA Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
WW Returned Product Analysis
| Conductor Fracture | 12 |
|---|---|
| Insulation Breach | 6 |
| Crimp/Weld/Bond | 0 |
| Other | 6 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Deployable Lobe Fixation |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular 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 November 8, 2019