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 | at 210.0 mo | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.6 | 99.4 | 99.3 | 99.1 | 99.0 | 98.6 | 98.5 | 98.2 | 97.8 | 97.8 | 97.5 | 97.5 | 97.0 | 95.8 | 95.8 | 95.8 | 95.8 | 95.8 | |||
# | 2197 | 1837 | 1507 | 1173 | 954 | 798 | 668 | 562 | 470 | 381 | 312 | 248 | 178 | 145 | 125 | 104 | 72 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3355 |
---|---|
Cumulative Months of Follow-Up | 156992 |
Number of Leads Active in Study | 799 |
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 | 99.4 | 99.3 | 99.1 | 98.8 | 98.6 | 98.4 | 98.3 | 98.3 | 98.2 | 98.1 | 97.9 | 97.6 | 97.3 | 97.1 | 97.1 | 96.7 | 96.7 | 96.7 | 96.7 | |
# | 7992 | 6675 | 5634 | 4679 | 3944 | 3219 | 2531 | 2055 | 1681 | 1293 | 1045 | 833 | 632 | 501 | 395 | 295 | 193 | 123 | 70 | 53 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 12432 |
---|---|
Cumulative Months of Follow-Up | 578296 |
Number of Leads Active in Study | 5235 |

US Acute Lead Observations
Cardiac Perforation | 1544 |
---|---|
Conductor Fracture | 31 |
Extra Cardiac Stimulation | 110 |
Failure to Capture | 2245 |
Failure to Sense | 1124 |
Impedance Out of Range | 367 |
Insulation Breach | 15 |
Lead Dislodgement | 4925 |
Oversensing | 724 |
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 May 10, 2023