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 | 16 yr | at 198.0 mo | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.4 | 99.3 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 98.8 | 98.8 | 98.1 | 98.1 | 97.3 | 97.3 | 97.3 | 97.3 | ||||
# | 1029 | 876 | 730 | 616 | 476 | 390 | 330 | 291 | 243 | 190 | 161 | 141 | 121 | 116 | 108 | 68 | 56 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1191 |
---|---|
Cumulative Months of Follow-Up | 78251 |
Number of Leads Active in Study | 195 |
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 | 16 yr | at 198.0 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 | 99.1 | ||||
# | 214 | 205 | 198 | 183 | 167 | 158 | 148 | 136 | 126 | 117 | 110 | 107 | 98 | 92 | 88 | 62 | 54 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 227 |
---|---|
Cumulative Months of Follow-Up | 28700 |
Number of Leads Active in Study | 68 |

US Acute Lead Observations
Cardiac Perforation | 32 |
---|---|
Conductor Fracture | 2 |
Extra Cardiac Stimulation | 3 |
Failure to Capture | 171 |
Failure to Sense | 12 |
Impedance Out of Range | 6 |
Lead Dislodgement | 201 |
Oversensing | 8 |

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 May 10, 2023