5086MRI
CapsureFix Novus MRI
VENTRICULAR PLACEMENT
Device Survival Probability
5086MRI_VEN_SURV
Loading...
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.6 | 96.3 | |||
| # | 2625 | 2208 | 1852 | 1403 | 618 | 192 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3049 |
|---|---|
| Cumulative Months of Follow-Up | 124788 |
| Number of Leads Active in Study | 1502 |
16
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 8 |
| Failure to Sense | 1 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 3 |
| Oversensing | 2 |
ATRIAL PLACEMENT
Device Survival Probability
5086MRI_ATR_SURV
Loading...
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.4 | 99.4 | 98.5 | |||
| # | 2651 | 2227 | 1865 | 1413 | 631 | 198 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3102 |
|---|---|
| Cumulative Months of Follow-Up | 125924 |
| Number of Leads Active in Study | 1526 |
16
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 1 |
| Lead Dislodgement | 11 |
| Oversensing | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 214 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 18 |
| Failure to Capture | 140 |
| Failure to Sense | 28 |
| Impedance Out of Range | 9 |
| Insulation Breach | 1 |
| Lead Dislodgement | 309 |
| Oversensing | 31 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 208575 |
| Estimated Active USA Implants | 182692 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 395147 |
USA Returned Product Analysis
| Conductor Fracture | 70 |
|---|---|
| Insulation Breach | 122 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
WW Returned Product Analysis
| Conductor Fracture | 93 |
|---|---|
| Insulation Breach | 142 |
| Crimp/Weld/Bond | 0 |
| Other | 16 |
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 11, 2019