4968
CapSure Epi
ALL

Device Survival Probability
4968_SURV
Loading...
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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.5 | 97.5 | 95.9 | 94.2 | 93.1 | 90.8 | 89.0 | 88.8 | 84.0 | 83.2 | 80.0 | 76.1 | 72.2 | ||||||||
# | 807 | 723 | 646 | 545 | 476 | 389 | 327 | 279 | 202 | 152 | 112 | 86 | 59 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 1034 |
---|---|
Cumulative Months of Follow-Up | 64046 |
Number of Leads Active in Study | 191 |

US Acute Lead Observations
Cardiac Perforation | 1 |
---|---|
Conductor Fracture | 4 |
Extra Cardiac Stimulation | 6 |
Failure to Capture | 68 |
Failure to Sense | 8 |
Impedance Out of Range | 14 |
Insulation Breach | 1 |
Lead Dislodgement | 7 |
Oversensing | 29 |

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 December 16, 2021