4194
Attain OTW
ALL
Device Survival Probability
4194_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | 15 yr | at 186.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 97.4 | 96.7 | 96.1 | 95.6 | 94.3 | 94.1 | 93.5 | 93.5 | 93.3 | 93.0 | 93.0 | 93.0 | 91.4 | 91.4 | 91.4 | |||||
| # | 1238 | 1045 | 897 | 769 | 697 | 616 | 505 | 429 | 367 | 315 | 257 | 188 | 139 | 94 | 62 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1654 |
|---|---|
| Cumulative Months of Follow-Up | 100787 |
| Number of Leads Active in Study | 144 |
68
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| Extra Cardiac Stimulation | 11 |
| Failure to Capture | 22 |
| Insulation (ESC) | 1 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 30 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 49 |
| Failure to Capture | 42 |
| Impedance Out of Range | 9 |
| Lead Dislodgement | 153 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Registered USA Implants | 114258 |
| Estimated Active USA Implants | 28425 |
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Estimated WW Distribution | 244151 |
USA Returned Product Analysis
| Conductor Fracture | 48 |
|---|---|
| Insulation Breach | 167 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
WW Returned Product Analysis
| Conductor Fracture | 54 |
|---|---|
| Insulation Breach | 173 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Double Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular 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 November 20, 2024