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 | at 174.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 97.4 | 96.7 | 96.1 | 95.6 | 94.3 | 94.1 | 93.3 | 93.3 | 93.1 | 92.7 | 92.7 | 92.7 | 91.6 | 91.6 | ||||||
| # | 1239 | 1047 | 899 | 771 | 699 | 617 | 505 | 425 | 350 | 283 | 221 | 149 | 103 | 68 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1654 |
|---|---|
| Cumulative Months of Follow-Up | 97689 |
| Number of Leads Active in Study | 210 |
68
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| Extra Cardiac Stimulation | 11 |
| Failure to Capture | 22 |
| Impedance Out of Range | 0 |
| Insulation (ESC) | 1 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 30 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| 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 | 114261 |
| Estimated Active USA Implants | 29033 |
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Estimated WW Distribution | 244145 |
USA Returned Product Analysis
| Conductor Fracture | 48 |
|---|---|
| Insulation Breach | 164 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
WW Returned Product Analysis
| Conductor Fracture | 54 |
|---|---|
| Insulation Breach | 170 |
| 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 May 10, 2023