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 | 8 yr | 9 yr | 10 yr | 11 yr | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.1 | 98.1 | 97.8 | 97.8 | 97.8 | 97.8 | ||||||||||
| # | 2527 | 2183 | 1851 | 1428 | 735 | 421 | 371 | 322 | 269 | 166 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3070 |
|---|---|
| Cumulative Months of Follow-Up | 140297 |
| Number of Leads Active in Study | 1326 |
22
Qualifying Complications
| Conductor Fracture | 4 |
|---|---|
| Failure to Capture | 9 |
| Failure to Sense | 1 |
| Impedance Out of Range | 2 |
| 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 | 8 yr | 9 yr | 10 yr | at 126.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.4 | 98.4 | 98.4 | 97.8 | 97.8 | ||||||||||
| # | 2528 | 2201 | 1878 | 1462 | 765 | 450 | 389 | 339 | 280 | 168 | 97 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3136 |
|---|---|
| Cumulative Months of Follow-Up | 142455 |
| Number of Leads Active in Study | 1349 |
21
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 12 |
| Oversensing | 2 |
| Other | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 212 |
|---|---|
| Conductor Fracture | 4 |
| Extra Cardiac Stimulation | 18 |
| Failure to Capture | 144 |
| Failure to Sense | 27 |
| Impedance Out of Range | 9 |
| Insulation Breach | 2 |
| Lead Dislodgement | 312 |
| Oversensing | 31 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 207785 |
| Estimated Active USA Implants | 128533 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 398373 |
USA Returned Product Analysis
| Conductor Fracture | 112 |
|---|---|
| Insulation Breach | 199 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
WW Returned Product Analysis
| Conductor Fracture | 136 |
|---|---|
| Insulation Breach | 220 |
| 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 May 10, 2023