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 | 8 yr | 9 yr | 10 yr | at 126.0 mo | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 98.7 | 97.9 | 97.7 | 97.4 | 96.9 | 96.7 | 96.7 | 96.4 | 96.4 | 96.4 | 96.4 | |||||||||||
# | 1162 | 939 | 772 | 655 | 550 | 465 | 400 | 321 | 236 | 115 | 64 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1470 |
---|---|
Cumulative Months of Follow-Up | 75878 |
Number of Leads Active in Study | 264 |
US Acute Lead Observations
Cardiac Perforation | 2 |
---|---|
Conductor Fracture | 1 |
Extra Cardiac Stimulation | 63 |
Failure to Capture | 36 |
Impedance Out of Range | 11 |
Insulation Breach | 4 |
Lead Dislodgement | 119 |
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 December 1, 2023