4968
CapSure Epi
ALL

Device Survival Probability
4968_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 | 97.6 | 96.1 | 94.3 | 93.2 | 91.0 | 89.1 | 89.1 | 84.5 | 83.5 | 79.9 | 75.4 | 72.0 | ||||||||
# | 799 | 716 | 619 | 529 | 452 | 367 | 316 | 266 | 186 | 138 | 100 | 74 | 61 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1027 |
---|---|
Cumulative Months of Follow-Up | 61494 |
Number of Leads Active in Study | 221 |

US Acute Lead Observations
Cardiac Perforation | 1 |
---|---|
Conductor Fracture | 3 |
Extra Cardiac Stimulation | 4 |
Failure to Capture | 62 |
Failure to Sense | 7 |
Impedance Out of Range | 10 |
Insulation Breach | 1 |
Lead Dislodgement | 7 |
Oversensing | 24 |

Product Characteristics
Lead Type | Epi/Myocardial |
---|---|
Type and/or Fixation | Suture |
Lead Function | Pacing/Sensing |
Lead Placement | Myocardial |
Lead Tip Location | Atrium or Right Ventricle |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | LEN |
---|---|
Lead Body Diameter | 7.8 FR |
Insulation | Silicone |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of October 29, 2020