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 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.8 | 99.8 | 99.8 | 99.7 | 99.4 | 99.4 | 99.0 | 99.0 | 98.7 | 98.7 | 98.7 | ||||||||||
# | 1319 | 1167 | 1039 | 869 | 653 | 542 | 427 | 317 | 192 | 120 | 73 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1570 |
---|---|
Cumulative Months of Follow-Up | 89859 |
Number of Leads Active in Study | 443 |
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 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.8 | 99.7 | 99.6 | 99.5 | 99.4 | 99.0 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | ||||||||||
# | 2897 | 2519 | 2169 | 1768 | 1288 | 905 | 652 | 425 | 227 | 132 | 63 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3453 |
---|---|
Cumulative Months of Follow-Up | 176180 |
Number of Leads Active in Study | 1467 |
Performance Notes For This Model

US Acute Lead Observations
Cardiac Perforation | 111 |
---|---|
Conductor Fracture | 6 |
Extra Cardiac Stimulation | 17 |
Failure to Capture | 145 |
Failure to Sense | 57 |
Impedance Out of Range | 24 |
Insulation Breach | 1 |
Lead Dislodgement | 376 |
Oversensing | 42 |
Unspecified Clinical Failure | 12 |

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 October 12, 2018