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 | 97.9 | 97.9 | 97.9 | 97.9 | |||||
# | 1427 | 1271 | 1125 | 943 | 753 | 657 | 551 | 472 | 391 | 322 | 266 | 209 | 148 | 104 | 69 | 53 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1746 |
---|---|
Cumulative Months of Follow-Up | 114067 |
Number of Leads Active in Study | 366 |
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 | at 186.0 mo | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.7 | 99.6 | 99.6 | 99.5 | 99.3 | 98.9 | 98.8 | 98.7 | 98.7 | 98.7 | 98.4 | 98.4 | 98.4 | 96.9 | 96.9 | 96.9 | |||||
# | 3318 | 2910 | 2527 | 2165 | 1850 | 1604 | 1412 | 1203 | 974 | 725 | 546 | 391 | 243 | 152 | 99 | 76 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 4529 |
---|---|
Cumulative Months of Follow-Up | 263099 |
Number of Leads Active in Study | 1626 |

US Acute Lead Observations
Cardiac Perforation | 234 |
---|---|
Conductor Fracture | 11 |
Extra Cardiac Stimulation | 28 |
Failure to Capture | 337 |
Failure to Sense | 185 |
Impedance Out of Range | 64 |
Insulation Breach | 2 |
Lead Dislodgement | 827 |
Oversensing | 119 |
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 May 10, 2023