4074
CapSure Sense
VENTRICULAR PLACEMENT

Device Survival Probability
4074_VEN_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 | 14 yr | 15 yr | at 186.0 mo | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.4 | 99.3 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 98.7 | 98.7 | 98.0 | 98.0 | 97.2 | 97.2 | 97.2 | |||||
# | 1017 | 859 | 707 | 596 | 467 | 380 | 323 | 269 | 218 | 173 | 151 | 138 | 119 | 103 | 66 | 55 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1188 |
---|---|
Cumulative Months of Follow-Up | 74402 |
Number of Leads Active in Study | 263 |
ATRIAL PLACEMENT

Device Survival Probability
4074_ATR_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 | 14 yr | 15 yr | at 186.0 mo | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | |||||
# | 214 | 205 | 198 | 183 | 167 | 158 | 148 | 136 | 126 | 117 | 109 | 103 | 94 | 84 | 57 | 52 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 227 |
---|---|
Cumulative Months of Follow-Up | 27251 |
Number of Leads Active in Study | 90 |

US Acute Lead Observations
Cardiac Perforation | 29 |
---|---|
Conductor Fracture | 2 |
Extra Cardiac Stimulation | 3 |
Failure to Capture | 148 |
Failure to Sense | 9 |
Impedance Out of Range | 4 |
Lead Dislodgement | 182 |
Oversensing | 7 |

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 | BBD |
---|---|
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 16, 2021