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 | 12 yr | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.3 | 98.3 | 98.0 | 98.0 | 98.0 | 98.0 | 97.4 | |||||||||
| # | 2526 | 2183 | 1850 | 1426 | 735 | 423 | 375 | 332 | 300 | 266 | 162 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3073 |
|---|---|
| Cumulative Months of Follow-Up | 144430 |
| Number of Leads Active in Study | 1268 |
20
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 8 |
| 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 | 11 yr | 12 yr | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.4 | 98.4 | 98.4 | 98.1 | 98.1 | 98.1 | |||||||||
| # | 2528 | 2202 | 1877 | 1460 | 766 | 452 | 397 | 352 | 317 | 281 | 169 | 68 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3142 |
|---|---|
| Cumulative Months of Follow-Up | 147112 |
| Number of Leads Active in Study | 1288 |
21
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 3 |
| 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 | 214 |
|---|---|
| Conductor Fracture | 4 |
| Extra Cardiac Stimulation | 18 |
| Failure to Capture | 144 |
| Failure to Sense | 29 |
| Impedance Out of Range | 9 |
| Insulation Breach | 2 |
| Lead Dislodgement | 311 |
| Oversensing | 31 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 207819 |
| Estimated Active USA Implants | 125891 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 398386 |
USA Returned Product Analysis
| Conductor Fracture | 119 |
|---|---|
| Insulation Breach | 216 |
| Crimp/Weld/Bond | 0 |
| Other | 12 |
WW Returned Product Analysis
| Conductor Fracture | 143 |
|---|---|
| Insulation Breach | 238 |
| Crimp/Weld/Bond | 0 |
| Other | 17 |
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 20, 2024