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 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 97.6 | 97.6 | |||||||
# | 1393 | 1227 | 1063 | 903 | 731 | 640 | 528 | 424 | 358 | 295 | 233 | 138 | 104 | 63 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1713 |
---|---|
Cumulative Months of Follow-Up | 106524 |
Number of Leads Active in Study | 408 |
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 | at 174.0 mo | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.8 | 99.7 | 99.6 | 99.5 | 99.3 | 98.9 | 98.8 | 98.7 | 98.7 | 98.7 | 98.3 | 98.3 | 98.3 | 96.5 | 96.5 | ||||||
# | 3128 | 2691 | 2317 | 2050 | 1756 | 1502 | 1277 | 992 | 751 | 594 | 417 | 229 | 153 | 83 | 53 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 4115 |
---|---|
Cumulative Months of Follow-Up | 235332 |
Number of Leads Active in Study | 1503 |

US Acute Lead Observations
Cardiac Perforation | 192 |
---|---|
Conductor Fracture | 10 |
Extra Cardiac Stimulation | 25 |
Failure to Capture | 266 |
Failure to Sense | 115 |
Impedance Out of Range | 44 |
Insulation Breach | 1 |
Lead Dislodgement | 713 |
Oversensing | 94 |
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 December 16, 2021