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 | 7 yr | at 90.0 mo | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.3 | 97.4 | 97.4 | ||
| # | 2644 | 2221 | 1853 | 1408 | 646 | 211 | 116 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3051 |
|---|---|
| Cumulative Months of Follow-Up | 126806 |
| Number of Leads Active in Study | 1477 |
17
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 8 |
| Failure to Sense | 1 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 3 |
| Oversensing | 2 |
| Other | 1 |
ATRIAL PLACEMENT
Device Survival Probability
5086MRI_ATR_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | at 90.0 mo | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.4 | 98.9 | 98.0 | 98.0 | ||
| # | 2670 | 2244 | 1867 | 1415 | 656 | 216 | 116 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3108 |
|---|---|
| Cumulative Months of Follow-Up | 127921 |
| Number of Leads Active in Study | 1504 |
19
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 11 |
| Oversensing | 1 |
| Other | 1 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 214 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 18 |
| Failure to Capture | 142 |
| 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 | 208592 |
| Estimated Active USA Implants | 181314 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 395149 |
USA Returned Product Analysis
| Conductor Fracture | 77 |
|---|---|
| Insulation Breach | 137 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
WW Returned Product Analysis
| Conductor Fracture | 100 |
|---|---|
| Insulation Breach | 157 |
| 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 November 8, 2019