5086MRI
CapsureFix Novus MRI
VENTRICULAR PLACEMENT
Device Survival Probability
5086MRI_VEN_SURV
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| 1 yr | 2 yr | at 30.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.8 | 99.8 | 99.8 | |||||||
| # | 1966 | 670 | 198 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2937 |
|---|---|
| Cumulative Months of Follow-Up | 47501 |
| Number of Leads Active in Study | 2374 |
6
Qualifying Complications
| Failure to Capture | 2 |
|---|---|
| Failure to Sense | 1 |
| Lead Dislodgement | 3 |
ATRIAL PLACEMENT
Device Survival Probability
5086MRI_ATR_SURV
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| 1 yr | 2 yr | at 30.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.9 | 99.8 | 99.8 | |||||||
| # | 1974 | 663 | 199 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2948 |
|---|---|
| Cumulative Months of Follow-Up | 47602 |
| Number of Leads Active in Study | 2378 |
4
Qualifying Complications
| Lead Dislodgement | 4 |
|---|
ALL
Device Survival Probability
5086MRI_SURV
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| at 0.0 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 | 184 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 14 |
| Failure to Capture | 114 |
| Failure to Sense | 25 |
| Impedance Out of Range | 9 |
| Insulation Breach | 1 |
| Lead Dislodgement | 264 |
| Oversensing | 27 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 194163 |
| Estimated Active USA Implants | 187031 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 339314 |
USA Returned Product Analysis
| Conductor Fracture | 11 |
|---|---|
| Insulation Breach | 24 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
WW Returned Product Analysis
| Conductor Fracture | 20 |
|---|---|
| Insulation Breach | 36 |
| Crimp/Weld/Bond | 0 |
| Other | 21 |
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 August 3, 2014