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 | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 97.5 | 97.5 | |||||||
| # | 1380 | 1197 | 1047 | 896 | 727 | 632 | 504 | 414 | 347 | 273 | 197 | 125 | 86 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1698 |
|---|---|
| Cumulative Months of Follow-Up | 103442 |
| Number of Leads Active in Study | 426 |
13
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 5 |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.7 | 99.6 | 99.5 | 99.3 | 98.9 | 98.8 | 98.7 | 98.7 | 98.7 | 98.2 | 98.2 | 98.2 | 96.7 | |||||||
| # | 3024 | 2595 | 2279 | 2003 | 1719 | 1451 | 1193 | 911 | 705 | 522 | 333 | 189 | 124 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4044 |
|---|---|
| Cumulative Months of Follow-Up | 224647 |
| Number of Leads Active in Study | 1536 |
31
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 10 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 8 |
| Oversensing | 1 |
| Other | 3 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 188 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 25 |
| Failure to Capture | 260 |
| Failure to Sense | 113 |
| Impedance Out of Range | 42 |
| Insulation Breach | 1 |
| Lead Dislodgement | 692 |
| Oversensing | 93 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 722569 |
| Estimated Active USA Implants | 391720 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1680570 |
USA Returned Product Analysis
| Conductor Fracture | 114 |
|---|---|
| Insulation Breach | 186 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
WW Returned Product Analysis
| Conductor Fracture | 135 |
|---|---|
| Insulation Breach | 195 |
| Crimp/Weld/Bond | 1 |
| Other | 30 |
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 October 11, 2021