5086MRI
CapsureFix Novus MRI
VENTRICULAR PLACEMENT
System Longevity Study Results
| Number of Leads Enrolled in Study | 2397 |
|---|---|
| Cumulative Months of Follow-Up | 13008 |
| Number of Leads Active in Study | 2220 |
ATRIAL PLACEMENT
System Longevity Study Results
| Number of Leads Enrolled in Study | 2406 |
|---|---|
| Cumulative Months of Follow-Up | 13080 |
| Number of Leads Active in Study | 2225 |
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 99 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 9 |
| Failure to Capture | 55 |
| Failure to Sense | 11 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 112 |
| Oversensing | 13 |
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 March 12, 2013