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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.4 | 99.1 | 98.7 | 98.6 | 98.3 | 97.6 | 97.6 | 97.2 | 97.2 | 97.2 | 97.2 | 97.2 | 97.2 | |||||||||
# | 1534 | 1002 | 717 | 455 | 350 | 272 | 221 | 186 | 154 | 116 | 100 | 74 | 50 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 2524 |
---|---|
Cumulative Months of Follow-Up | 73178 |
Number of Leads Active in Study | 1695 |
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 | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | 98.3 | 97.4 | 97.0 | 95.8 | 94.8 | 93.6 | 93.6 | ||||
# | 1092 | 773 | 479 | 240 | 106 | 64 | 51 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1435 |
---|---|
Cumulative Months of Follow-Up | 40363 |
Number of Leads Active in Study | 953 |
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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.6 | 99.3 | 99.3 | 99.2 | 99.0 | 98.8 | 98.3 | 97.7 | 97.4 | 96.6 | 96.6 | 96.6 | 96.6 | |||||||||
# | 1308 | 1032 | 833 | 649 | 517 | 436 | 357 | 313 | 263 | 213 | 186 | 126 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1774 |
---|---|
Cumulative Months of Follow-Up | 84591 |
Number of Leads Active in Study | 756 |
US Acute Lead Observations
Cardiac Perforation | 62 |
---|---|
Conductor Fracture | 5 |
Extra Cardiac Stimulation | 10 |
Failure to Capture | 530 |
Failure to Sense | 74 |
Impedance Out of Range | 39 |
Insulation Breach | 2 |
Lead Dislodgement | 635 |
Oversensing | 106 |
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 1, 2023