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 | at 102.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.6 | 99.6 | 99.6 | 99.1 | 98.0 | 97.6 | 97.6 | |
| # | 2532 | 2188 | 1856 | 1433 | 734 | 401 | 311 | 199 | 108 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3059 |
|---|---|
| Cumulative Months of Follow-Up | 132885 |
| Number of Leads Active in Study | 1417 |
20
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| 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 | at 102.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.3 | 98.3 | 98.3 | |
| # | 2535 | 2208 | 1883 | 1466 | 761 | 430 | 322 | 206 | 109 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3120 |
|---|---|
| Cumulative Months of Follow-Up | 134691 |
| Number of Leads Active in Study | 1433 |
20
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 11 |
| Oversensing | 2 |
| Other | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 213 |
|---|---|
| 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 | 310 |
| Oversensing | 31 |
Distribution Data
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Registered USA Implants | 208670 |
| Estimated Active USA Implants | 132388 |
| US Market Release | 2011-02-08 |
|---|---|
| CE Approval Date | 2009-01-21 |
| Estimated WW Distribution | 398394 |
USA Returned Product Analysis
| Conductor Fracture | 98 |
|---|---|
| Insulation Breach | 176 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
WW Returned Product Analysis
| Conductor Fracture | 122 |
|---|---|
| Insulation Breach | 197 |
| 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 October 11, 2021