5076
CapSureFix Novus
VENTRICULAR PLACEMENT
Device Survival Probability
5076_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 | 16 yr | 17 yr | 18 yr | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.5 | 99.3 | 99.2 | 99.1 | 98.9 | 98.6 | 98.3 | 98.0 | 97.6 | 97.6 | 97.3 | 97.3 | 96.9 | 95.7 | 95.7 | 95.7 | 95.7 | 95.7 | ||||
# | 2222 | 1886 | 1560 | 1244 | 996 | 827 | 688 | 579 | 498 | 405 | 325 | 257 | 186 | 152 | 128 | 109 | 77 | 55 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3387 |
---|---|
Cumulative Months of Follow-Up | 162124 |
Number of Leads Active in Study | 749 |
ATRIAL PLACEMENT
Device Survival Probability
5076_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 | 17 yr | 18 yr | 19 yr | at 234.0 mo | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.6 | 99.5 | 99.3 | 99.1 | 98.8 | 98.7 | 98.5 | 98.3 | 98.3 | 98.3 | 98.2 | 98.0 | 97.7 | 97.4 | 97.2 | 97.2 | 96.9 | 96.9 | 96.9 | 96.9 | ||
# | 8441 | 6914 | 5877 | 4888 | 4079 | 3412 | 2727 | 2173 | 1773 | 1382 | 1086 | 874 | 673 | 521 | 420 | 335 | 223 | 142 | 84 | 65 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 13115 |
---|---|
Cumulative Months of Follow-Up | 608439 |
Number of Leads Active in Study | 5396 |
US Acute Lead Observations
Cardiac Perforation | 1621 |
---|---|
Conductor Fracture | 32 |
Extra Cardiac Stimulation | 114 |
Failure to Capture | 2387 |
Failure to Sense | 1452 |
Impedance Out of Range | 400 |
Insulation Breach | 15 |
Lead Dislodgement | 5159 |
Oversensing | 800 |
Unspecified Clinical Failure | 26 |
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 | PJN |
---|---|
Lead Body Diameter | 6.0 FR |
Insulation | Silicone |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of December 1, 2023