5086MRI
CapsureFix Novus MRI
VENTRICULAR PLACEMENT
Device Survival Probability
| 1 yr | 2 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | ||||||||
| # | 1439 | 121 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2789 |
|---|---|
| Cumulative Months of Follow-Up | 33141 |
| Number of Leads Active in Study | 2362 |
6
Qualifying Complications
| Failure to Capture | 2 |
|---|---|
| Failure to Sense | 1 |
| Lead Dislodgement | 3 |
ATRIAL PLACEMENT
Device Survival Probability
| 1 yr | 2 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.9 | 99.5 | ||||||||
| # | 1435 | 122 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2800 |
|---|---|
| Cumulative Months of Follow-Up | 33201 |
| Number of Leads Active in Study | 2372 |
5
Qualifying Complications
| Failure to Sense | 1 |
|---|---|
| Lead Dislodgement | 4 |
ALL
Device Survival Probability
| at 0 mo |
|---|
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | |
|---|---|
| Cumulative Months of Follow-Up | |
| Number of Leads Active in Study |
Qualifying Complications
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 148 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 10 |
| Failure to Capture | 91 |
| Failure to Sense | 18 |
| Impedance Out of Range | 9 |
| Insulation Breach | 1 |
| Lead Dislodgement | 188 |
| Oversensing | 22 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 159331 |
| Estimated Active USA Implants | 153559 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 291516 |
USA Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 15 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 18 |
|---|---|
| Insulation Breach | 27 |
| Crimp/Weld/Bond | 0 |
| Other | 19 |
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 January 31, 2014