4076
CapSureFix Novus
VENTRICULAR PLACEMENT
Device Survival Probability
4076_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 | 13 yr | 14 yr | 15 yr | 16 yr | 17 yr | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.8 | 98.6 | 98.6 | 98.6 | 98.1 | 98.1 | 98.1 | 97.1 | 97.1 | ||||
| # | 1462 | 1313 | 1169 | 1010 | 817 | 706 | 576 | 495 | 435 | 374 | 316 | 245 | 206 | 173 | 134 | 84 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1778 |
|---|---|
| Cumulative Months of Follow-Up | 124770 |
| Number of Leads Active in Study | 195 |
14
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 6 |
| Failure to Sense | 1 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 1 |
| Other | 2 |
ATRIAL PLACEMENT
Device Survival Probability
4076_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 | 13 yr | 14 yr | 15 yr | 16 yr | 17 yr | 18 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.7 | 99.7 | 99.6 | 99.5 | 99.4 | 99.1 | 99.0 | 98.9 | 98.9 | 98.9 | 98.7 | 98.7 | 98.4 | 97.7 | 97.3 | 97.3 | 97.3 | 97.3 | |||
| # | 4013 | 3332 | 2825 | 2449 | 2075 | 1752 | 1500 | 1313 | 1137 | 964 | 769 | 567 | 420 | 328 | 230 | 137 | 99 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 5123 |
|---|---|
| Cumulative Months of Follow-Up | 312607 |
| Number of Leads Active in Study | 1461 |
39
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 3 |
| Failure to Capture | 9 |
| Failure to Sense | 3 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 14 |
| Oversensing | 2 |
| Other | 2 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 298 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 30 |
| Failure to Capture | 503 |
| Failure to Sense | 345 |
| Impedance Out of Range | 96 |
| Insulation Breach | 2 |
| Lead Dislodgement | 1067 |
| Oversensing | 198 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 888361 |
| Estimated Active USA Implants | 531305 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 2360015 |
USA Returned Product Analysis
| Conductor Fracture | 138 |
|---|---|
| Insulation Breach | 238 |
| Crimp/Weld/Bond | 2 |
| Other | 24 |
WW Returned Product Analysis
| Conductor Fracture | 162 |
|---|---|
| Insulation Breach | 251 |
| Crimp/Weld/Bond | 2 |
| Other | 34 |
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 | BBL |
|---|---|
| Lead Body Diameter | 5.7 FR |
| Insulation | Polyurethane/Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of December 1, 2025