5086MRI
CapsureFix Novus MRI
VENTRICULAR PLACEMENT
Device Survival Probability
5086MRI_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 | at 138.0 mo | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.3 | 98.3 | 98.0 | 98.0 | 98.0 | 98.0 | 97.2 | ||||||||||
# | 2526 | 2183 | 1850 | 1427 | 735 | 423 | 375 | 330 | 295 | 242 | 125 | 75 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3071 |
---|---|
Cumulative Months of Follow-Up | 143033 |
Number of Leads Active in Study | 1290 |
ATRIAL PLACEMENT
Device Survival Probability
5086MRI_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 | at 138.0 mo | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.4 | 98.4 | 98.4 | 98.0 | 98.0 | 98.0 | ||||||||||
# | 2528 | 2201 | 1877 | 1461 | 766 | 452 | 397 | 347 | 312 | 252 | 128 | 75 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3139 |
---|---|
Cumulative Months of Follow-Up | 145486 |
Number of Leads Active in Study | 1316 |
US Acute Lead Observations
Cardiac Perforation | 212 |
---|---|
Conductor Fracture | 4 |
Extra Cardiac Stimulation | 18 |
Failure to Capture | 143 |
Failure to Sense | 29 |
Impedance Out of Range | 9 |
Insulation Breach | 2 |
Lead Dislodgement | 313 |
Oversensing | 31 |
Product Characteristics
Lead Type | Pacing |
---|---|
Type and/or Fixation | Active Screw In |
Lead Function | Pacing/Sensing |
Lead Placement | Transvenous |
Lead Tip Location | Atrium or Right Ventricle |
Pace/Sense Polarity | Bipolar |
Serial Number Prefix | LFP |
---|---|
Lead Body Diameter | 6.9 FR |
Insulation | Silicone |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | n/a |
Steroid | Yes |
Data as of April 30, 2024