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 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.1 | 98.1 | 97.8 | 97.8 | 97.8 | 97.8 | ||||||||||
# | 2527 | 2183 | 1851 | 1428 | 735 | 421 | 371 | 322 | 269 | 166 | 50 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3070 |
---|---|
Cumulative Months of Follow-Up | 140297 |
Number of Leads Active in Study | 1326 |
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 | at 126.0 mo | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.4 | 98.4 | 98.4 | 97.8 | 97.8 | ||||||||||
# | 2528 | 2201 | 1878 | 1462 | 765 | 450 | 389 | 339 | 280 | 168 | 97 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3136 |
---|---|
Cumulative Months of Follow-Up | 142455 |
Number of Leads Active in Study | 1349 |

US Acute Lead Observations
Cardiac Perforation | 212 |
---|---|
Conductor Fracture | 4 |
Extra Cardiac Stimulation | 18 |
Failure to Capture | 144 |
Failure to Sense | 27 |
Impedance Out of Range | 9 |
Insulation Breach | 2 |
Lead Dislodgement | 312 |
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 May 10, 2023