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 | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.1 | 97.9 | 97.3 | ||
# | 2532 | 2188 | 1856 | 1434 | 733 | 394 | 263 | 116 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3057 |
---|---|
Cumulative Months of Follow-Up | 130875 |
Number of Leads Active in Study | 1432 |
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 | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.3 | 98.3 | ||
# | 2535 | 2208 | 1883 | 1465 | 758 | 418 | 268 | 124 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 3117 |
---|---|
Cumulative Months of Follow-Up | 132521 |
Number of Leads Active in Study | 1450 |

US Acute Lead Observations
Cardiac Perforation | 213 |
---|---|
Conductor Fracture | 2 |
Extra Cardiac Stimulation | 18 |
Failure to Capture | 142 |
Failure to Sense | 28 |
Impedance Out of Range | 9 |
Insulation Breach | 1 |
Lead Dislodgement | 309 |
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 October 29, 2020