5071
Screw-in
ALL
Device Survival Probability
5071_SURV
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1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | at 90.0 mo | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | 95.0 | 91.9 | 90.2 | 90.2 | 88.8 | 87.2 | 86.2 | 84.7 | |||
# | 236 | 190 | 160 | 142 | 121 | 96 | 73 | 58 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 471 |
---|---|
Cumulative Months of Follow-Up | 17553 |
Number of Leads Active in Study | 51 |
US Acute Lead Observations
Cardiac Perforation | 2 |
---|---|
Extra Cardiac Stimulation | 6 |
Failure to Capture | 110 |
Failure to Sense | 4 |
Impedance Out of Range | 14 |
Lead Dislodgement | 4 |
Oversensing | 2 |
Unspecified Clinical Failure | 1 |
Product Characteristics
Lead Type | Epi/Myocardial |
---|---|
Type and/or Fixation | Fixed Screw |
Lead Function | Pacing/Sensing |
Lead Placement | Myocardial |
Lead Tip Location | Right Ventricle |
Pace/Sense Polarity | Unipolar |
Serial Number Prefix | LAQ |
---|---|
Lead Body Diameter | 6.6 FR |
Insulation | Silicon |
Pace/Sense Connector Style | IS-1 UNI |
High Voltage Connector | n/a |
Steroid | None |
Data as of April 30, 2024