3830
SelectSecure
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 | 11 yr | 12 yr | at 150.0 mo | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.5 | 99.1 | 98.8 | 98.6 | 98.4 | 97.8 | 97.8 | 97.3 | 97.3 | 97.3 | 97.3 | 97.3 | 97.3 | |||||||||
# | 1829 | 1156 | 813 | 501 | 369 | 286 | 230 | 187 | 159 | 121 | 106 | 87 | 68 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 2575 |
---|---|
Cumulative Months of Follow-Up | 82642 |
Number of Leads Active in Study | 1626 |
HIS BUNDLE PLACEMENT
Device Survival Probability
3830_HIS_SURV
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1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 78.0 mo | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | 98.2 | 97.3 | 97.0 | 96.0 | 94.8 | 93.7 | 93.7 | ||||
# | 1158 | 884 | 576 | 308 | 143 | 79 | 61 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1490 |
---|---|
Cumulative Months of Follow-Up | 45837 |
Number of Leads Active in Study | 957 |
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 | 12 yr | 13 yr | at 162.0 mo | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.6 | 99.3 | 99.3 | 99.2 | 99.1 | 98.9 | 98.4 | 97.8 | 97.5 | 96.7 | 96.7 | 96.7 | 96.7 | 96.7 | ||||||||
# | 1394 | 1083 | 887 | 678 | 536 | 444 | 366 | 315 | 268 | 219 | 192 | 152 | 77 | 53 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1827 |
---|---|
Cumulative Months of Follow-Up | 88926 |
Number of Leads Active in Study | 703 |
US Acute Lead Observations
Cardiac Perforation | 73 |
---|---|
Conductor Fracture | 5 |
Extra Cardiac Stimulation | 11 |
Failure to Capture | 578 |
Failure to Sense | 88 |
Impedance Out of Range | 47 |
Insulation Breach | 2 |
Lead Dislodgement | 722 |
Oversensing | 120 |
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 April 30, 2024