4592
CapSure SP Novus
ALL
Device Survival Probability
4592_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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 97.7 | 97.7 | 97.7 | 97.7 | 97.0 | 97.0 | 97.0 | 96.1 | 96.1 | 96.1 | 96.1 | 96.1 | 96.1 | |||||||||
# | 203 | 181 | 166 | 157 | 133 | 125 | 108 | 104 | 97 | 86 | 81 | 75 | 56 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 366 |
---|---|
Cumulative Months of Follow-Up | 22549 |
Number of Leads Active in Study | 27 |
US Acute Lead Observations
Failure to Capture | 10 |
---|---|
Failure to Sense | 2 |
Insulation Breach | 1 |
Lead Dislodgement | 37 |
Oversensing | 2 |
Unspecified Clinical Failure | 2 |
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 | LER |
---|---|
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