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 | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.5 | 99.3 | 99.2 | 99.0 | 98.8 | 98.4 | 98.3 | 97.8 | 97.3 | 97.3 | 97.0 | 97.0 | 96.4 | 95.6 | 95.6 | 95.6 | |||||
# | 1929 | 1490 | 1205 | 976 | 836 | 703 | 526 | 421 | 362 | 305 | 251 | 201 | 150 | 115 | 79 | 51 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3108 |
---|---|
Cumulative Months of Follow-Up | 129553 |
Number of Leads Active in Study | 934 |
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 | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.6 | 99.5 | 99.4 | 99.1 | 98.8 | 98.6 | 98.4 | 98.2 | 98.2 | 98.1 | 98.0 | 97.7 | 97.6 | 97.3 | 97.3 | 97.3 | 97.3 | ||||
# | 6521 | 5407 | 4548 | 3605 | 2869 | 2366 | 1872 | 1489 | 1239 | 999 | 805 | 644 | 489 | 330 | 206 | 132 | 69 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 9874 |
---|---|
Cumulative Months of Follow-Up | 446886 |
Number of Leads Active in Study | 4321 |

US Acute Lead Observations
Cardiac Perforation | 1212 |
---|---|
Conductor Fracture | 25 |
Extra Cardiac Stimulation | 92 |
Failure to Capture | 1513 |
Failure to Sense | 632 |
Impedance Out of Range | 192 |
Insulation Breach | 11 |
Lead Dislodgement | 3752 |
Oversensing | 473 |
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 October 29, 2020