2187
Attain LV
ALL
Device Survival Probability
2187_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 98.0 | 98.0 | 98.0 | ||||||
| # | 101 | 85 | 65 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 140 |
|---|---|
| Cumulative Months of Follow-Up | 7156 |
| Number of Leads Active in Study | 5 |
3
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Impedance Out of Range | 0 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Lead Dislodgement | 9 |
Distribution Data
| US Market Release | 2001-08-28 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 11921 |
| Estimated Active USA Implants | 990 |
| US Market Release | 2001-08-28 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 25698 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
WW Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Distal Continous Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Unipolar |
| Serial Number Prefix | LEY |
|---|---|
| Lead Body Diameter | 6.2 FR |
| Insulation | Polyurethane (55D) |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | None |
Data as of May 10, 2023