4574
CapSure Sense
ALL

Device Survival Probability
4574_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 | ||
---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.1 | 99.1 | 99.1 | 98.9 | 98.7 | 98.4 | 98.4 | 98.4 | 98.4 | 98.4 |
# | 1026 | 812 | 662 | 516 | 407 | 312 | 230 | 177 | 103 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1420 |
---|---|
Cumulative Months of Follow-Up | 60314 |
Number of Leads Active in Study | 676 |

US Acute Lead Observations
Cardiac Perforation | 1 |
---|---|
Conductor Fracture | 1 |
Extra Cardiac Stimulation | 1 |
Failure to Capture | 98 |
Failure to Sense | 46 |
Impedance Out of Range | 7 |
Lead Dislodgement | 221 |
Oversensing | 13 |
Unspecified Clinical Failure | 4 |

Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | J-shape, tines |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Atrium |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | BBE |
---|---|
Lead Body Diameter | 5.3 FR |
Insulation | Polyurethane (outer) Silicone (inner) |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of December 16, 2021