5092
CapSure SP Novus
ALL

Device Survival Probability
5092_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 | at 150.0 mo | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.5 | 99.3 | 99.1 | 98.9 | 98.9 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 97.8 | 97.8 | 97.8 | ||||||||
# | 827 | 659 | 524 | 426 | 331 | 257 | 207 | 163 | 136 | 118 | 95 | 70 | 61 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1210 |
---|---|
Cumulative Months of Follow-Up | 52798 |
Number of Leads Active in Study | 35 |
Performance Notes For This Model

US Acute Lead Observations
Cardiac Perforation | 7 |
---|---|
Conductor Fracture | 2 |
Extra Cardiac Stimulation | 3 |
Failure to Capture | 49 |
Failure to Sense | 7 |
Impedance Out of Range | 1 |
Insulation Breach | 3 |
Lead Dislodgement | 72 |
Oversensing | 1 |
Unspecified Clinical Failure | 9 |

Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | Tines |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Right Ventricle |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | LET |
---|---|
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 October 12, 2018