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 | at 186.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.3 | 99.3 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 97.9 | 97.9 | 97.9 | 97.9 | |||||
| # | 1427 | 1271 | 1125 | 943 | 753 | 657 | 551 | 472 | 391 | 322 | 266 | 209 | 148 | 104 | 69 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1746 |
|---|---|
| Cumulative Months of Follow-Up | 114067 |
| Number of Leads Active in Study | 366 |
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 | at 186.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.7 | 99.6 | 99.6 | 99.5 | 99.3 | 98.9 | 98.8 | 98.7 | 98.7 | 98.7 | 98.4 | 98.4 | 98.4 | 96.9 | 96.9 | 96.9 | |||||
| # | 3318 | 2910 | 2527 | 2165 | 1850 | 1604 | 1412 | 1203 | 974 | 725 | 546 | 391 | 243 | 152 | 99 | 76 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4529 |
|---|---|
| Cumulative Months of Follow-Up | 263099 |
| Number of Leads Active in Study | 1626 |
37
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 3 |
| Failure to Capture | 10 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 12 |
| Oversensing | 2 |
| Other | 2 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 234 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 28 |
| Failure to Capture | 337 |
| Failure to Sense | 185 |
| Impedance Out of Range | 64 |
| Insulation Breach | 2 |
| Lead Dislodgement | 827 |
| Oversensing | 119 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 777799 |
| Estimated Active USA Implants | 439266 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1941695 |
USA Returned Product Analysis
| Conductor Fracture | 125 |
|---|---|
| Insulation Breach | 206 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
WW Returned Product Analysis
| Conductor Fracture | 147 |
|---|---|
| Insulation Breach | 217 |
| Crimp/Weld/Bond | 1 |
| Other | 31 |
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 May 10, 2023