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 | at 78.0 mo | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.2 | 99.2 | 99.2 | 98.9 | 98.6 | 98.6 | 98.6 | |||
# | 847 | 627 | 465 | 339 | 224 | 114 | 63 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1106 |
---|---|
Cumulative Months of Follow-Up | 38371 |
Number of Leads Active in Study | 607 |
Performance Notes For This Model

US Acute Lead Observations
Conductor Fracture | 1 |
---|---|
Extra Cardiac Stimulation | 1 |
Failure to Capture | 56 |
Failure to Sense | 21 |
Impedance Out of Range | 3 |
Lead Dislodgement | 136 |
Oversensing | 1 |
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 October 12, 2018