4296
Attain Ability Plus
ALL
Device Survival Probability
4296_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.7 | 97.9 | 97.6 | 97.2 | 96.7 | 96.4 | 96.4 | |||
| # | 1150 | 914 | 744 | 611 | 429 | 203 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1456 |
|---|---|
| Cumulative Months of Follow-Up | 57484 |
| Number of Leads Active in Study | 480 |
35
Qualifying Complications
| Extra Cardiac Stimulation | 12 |
|---|---|
| Failure to Capture | 9 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 13 |
| Other | 1 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 61 |
| Failure to Capture | 30 |
| Impedance Out of Range | 10 |
| Insulation Breach | 4 |
| Lead Dislodgement | 115 |
Distribution Data
| US Market Release | 2011-04-01 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Registered USA Implants | 34672 |
| Estimated Active USA Implants | 27553 |
| US Market Release | 2011-04-01 |
|---|---|
| CE Approval Date | 2009-12-18 |
| Estimated WW Distribution | 108183 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 2 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 8 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 2 |
| 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 | Dual Electrodes |
| Serial Number Prefix | RRA |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of November 8, 2019