4076
CapSureFix Novus
VENTRICULAR PLACEMENT
Device Survival Probability
4076_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 | 13 yr | 14 yr | 15 yr | at 186.0 mo | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.7 | 99.7 | 99.7 | 99.6 | 99.3 | 99.3 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 98.0 | 98.0 | 98.0 | 98.0 | ||||||
# | 1443 | 1286 | 1136 | 963 | 769 | 666 | 558 | 481 | 413 | 327 | 275 | 221 | 172 | 115 | 82 | 69 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1760 |
---|---|
Cumulative Months of Follow-Up | 116900 |
Number of Leads Active in Study | 351 |
ATRIAL PLACEMENT
Device Survival Probability
4076_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 | 14 yr | 15 yr | 16 yr | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.7 | 99.6 | 99.6 | 99.5 | 99.4 | 99.0 | 98.9 | 98.8 | 98.8 | 98.8 | 98.5 | 98.5 | 98.5 | 97.3 | 97.3 | 97.3 | ||||||
# | 3400 | 2963 | 2583 | 2216 | 1879 | 1628 | 1433 | 1230 | 1022 | 787 | 576 | 426 | 301 | 184 | 118 | 64 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 4720 |
---|---|
Cumulative Months of Follow-Up | 271871 |
Number of Leads Active in Study | 1682 |
US Acute Lead Observations
Cardiac Perforation | 245 |
---|---|
Conductor Fracture | 11 |
Extra Cardiac Stimulation | 27 |
Failure to Capture | 370 |
Failure to Sense | 258 |
Impedance Out of Range | 68 |
Insulation Breach | 2 |
Lead Dislodgement | 875 |
Oversensing | 140 |
Unspecified Clinical Failure | 10 |
Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | Active Screw In |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Atrium or Right Ventricle |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | BBL |
---|---|
Lead Body Diameter | 5.7 FR |
Insulation | Polyurethane/Silicone |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of December 1, 2023