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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.6 | ||||
| # | 2586 | 2200 | 1847 | 1384 | 587 | 128 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3045 |
|---|---|
| Cumulative Months of Follow-Up | 122022 |
| Number of Leads Active in Study | 1525 |
12
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 6 |
| Failure to Sense | 1 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 3 |
ATRIAL PLACEMENT
Device Survival Probability
5086MRI_ATR_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.4 | 99.4 | ||||
| # | 2615 | 2215 | 1860 | 1394 | 598 | 131 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3098 |
|---|---|
| Cumulative Months of Follow-Up | 123112 |
| Number of Leads Active in Study | 1550 |
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 | 17 |
| Failure to Capture | 140 |
| Failure to Sense | 28 |
| Impedance Out of Range | 9 |
| Insulation Breach | 1 |
| Lead Dislodgement | 308 |
| Oversensing | 30 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 208554 |
| Estimated Active USA Implants | 183442 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 395150 |
USA Returned Product Analysis
| Conductor Fracture | 65 |
|---|---|
| Insulation Breach | 113 |
| Crimp/Weld/Bond | 0 |
| Other | 12 |
WW Returned Product Analysis
| Conductor Fracture | 87 |
|---|---|
| Insulation Breach | 132 |
| Crimp/Weld/Bond | 0 |
| Other | 23 |
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 12, 2018