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 | at 162.0 mo | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.5 | 99.3 | 99.2 | 99.0 | 98.7 | 98.2 | 98.0 | 97.5 | 96.9 | 96.9 | 96.6 | 96.6 | 95.9 | 95.9 | |||||||
# | 1750 | 1424 | 1173 | 928 | 658 | 505 | 404 | 307 | 236 | 198 | 163 | 119 | 73 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 2675 |
---|---|
Cumulative Months of Follow-Up | 108782 |
Number of Leads Active in Study | 785 |
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 | at 174.0 mo | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.6 | 99.5 | 99.4 | 99.1 | 98.8 | 98.6 | 98.3 | 98.2 | 98.2 | 98.1 | 97.9 | 97.8 | 97.8 | 97.3 | 97.3 | ||||||
# | 6173 | 4839 | 3783 | 3014 | 2186 | 1553 | 1170 | 848 | 597 | 468 | 368 | 242 | 142 | 76 | 54 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 8394 |
---|---|
Cumulative Months of Follow-Up | 348981 |
Number of Leads Active in Study | 3907 |
Performance Notes For This Model

US Acute Lead Observations
Cardiac Perforation | 866 |
---|---|
Conductor Fracture | 22 |
Extra Cardiac Stimulation | 66 |
Failure to Capture | 1020 |
Failure to Sense | 351 |
Impedance Out of Range | 77 |
Insulation Breach | 9 |
Lead Dislodgement | 2629 |
Oversensing | 276 |
Unspecified Clinical Failure | 31 |

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 October 12, 2018