5592
CapSure SP Novus
ALL

Device Survival Probability
5592_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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.6 | 99.2 | 99.2 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | ||||||||
# | 523 | 432 | 351 | 299 | 249 | 197 | 169 | 154 | 132 | 118 | 100 | 71 | 51 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 722 |
---|---|
Cumulative Months of Follow-Up | 39777 |
Number of Leads Active in Study | 27 |

US Acute Lead Observations
Cardiac Perforation | 1 |
---|---|
Failure to Capture | 4 |
Failure to Sense | 3 |
Lead Dislodgement | 43 |
Oversensing | 1 |
Unspecified Clinical Failure | 1 |

Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | Tines |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Atrium - J |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | LEU |
---|---|
Lead Body Diameter | 6.0 FR |
Insulation | Silicone |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of November 20, 2024