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 | at 162.0 mo | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
98.6 | 97.4 | 96.7 | 96.1 | 95.6 | 94.4 | 94.3 | 93.4 | 93.4 | 93.1 | 92.7 | 92.7 | 92.7 | 92.7 | |||||||
# | 1238 | 1046 | 898 | 769 | 695 | 614 | 494 | 390 | 311 | 251 | 175 | 108 | 73 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1647 |
---|---|
Cumulative Months of Follow-Up | 93896 |
Number of Leads Active in Study | 250 |

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 |

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 December 16, 2021