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 | 11 yr | at 138.0 mo | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.2 | 99.2 | 99.2 | 99.1 | 98.9 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | ||||||||||
# | 1236 | 943 | 761 | 617 | 491 | 407 | 345 | 268 | 201 | 141 | 83 | 61 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1700 |
---|---|
Cumulative Months of Follow-Up | 76336 |
Number of Leads Active in Study | 713 |
US Acute Lead Observations
Cardiac Perforation | 4 |
---|---|
Conductor Fracture | 1 |
Extra Cardiac Stimulation | 1 |
Failure to Capture | 146 |
Failure to Sense | 80 |
Impedance Out of Range | 10 |
Lead Dislodgement | 267 |
Oversensing | 16 |
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 1, 2023