3830
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VENTRICULAR PLACEMENT

Device Survival Probability
3830_VEN_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 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.2 | 98.9 | 98.5 | 98.3 | 98.3 | 97.5 | 97.5 | 97.0 | 97.0 | 97.0 | 97.0 | ||||||||||
# | 920 | 623 | 496 | 368 | 300 | 245 | 205 | 162 | 132 | 85 | 54 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1454 |
---|---|
Cumulative Months of Follow-Up | 49094 |
Number of Leads Active in Study | 877 |
HIS BUNDLE PLACEMENT

Device Survival Probability
3830_HIS_SURV
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1 yr | 2 yr | 3 yr | 4 yr | 5 yr | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
97.9 | 96.5 | 96.1 | 94.5 | 91.6 | |||||
# | 671 | 300 | 139 | 84 | 50 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1143 |
---|---|
Cumulative Months of Follow-Up | 20012 |
Number of Leads Active in Study | 903 |
ATRIAL PLACEMENT

Device Survival Probability
3830_ATR_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 | at 138.0 mo | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.5 | 99.2 | 99.2 | 99.1 | 98.9 | 98.7 | 98.1 | 97.5 | 97.2 | 96.2 | 96.2 | 96.2 | |||||||||
# | 1070 | 847 | 703 | 566 | 463 | 398 | 338 | 287 | 237 | 160 | 71 | 53 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1418 |
---|---|
Cumulative Months of Follow-Up | 69373 |
Number of Leads Active in Study | 640 |

US Acute Lead Observations
Cardiac Perforation | 34 |
---|---|
Conductor Fracture | 3 |
Extra Cardiac Stimulation | 8 |
Failure to Capture | 317 |
Failure to Sense | 28 |
Impedance Out of Range | 8 |
Insulation Breach | 1 |
Lead Dislodgement | 368 |
Oversensing | 78 |
Unspecified Clinical Failure | 2 |

Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | Fixed Screw |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Atrium or Right Ventricle or Bundle of His |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | LFF |
---|---|
Lead Body Diameter | 4.1 FR |
Insulation | Polyurethane (outer) Silicone (inner) |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of December 16, 2021