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 | 97.2 | 97.2 | ||||
| # | 1464 | 1314 | 1171 | 1012 | 818 | 711 | 582 | 498 | 437 | 376 | 323 | 251 | 209 | 175 | 139 | 94 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1779 |
|---|---|
| Cumulative Months of Follow-Up | 125728 |
| Number of Leads Active in Study | 183 |
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 | 98.5 | 97.7 | 97.4 | 97.4 | 97.4 | 97.4 | |||
| # | 4077 | 3481 | 2906 | 2493 | 2104 | 1786 | 1516 | 1323 | 1145 | 984 | 794 | 596 | 439 | 338 | 255 | 164 | 110 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 5123 |
|---|---|
| Cumulative Months of Follow-Up | 320464 |
| Number of Leads Active in Study | 1226 |
38
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 3 |
| Failure to Capture | 9 |
| Failure to Sense | 3 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 13 |
| 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 | 307 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 30 |
| Failure to Capture | 548 |
| Failure to Sense | 360 |
| Impedance Out of Range | 104 |
| Insulation Breach | 2 |
| Lead Dislodgement | 1121 |
| Oversensing | 210 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 906901 |
| Estimated Active USA Implants | 546169 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 2439885 |
USA Returned Product Analysis
| Conductor Fracture | 141 |
|---|---|
| Insulation Breach | 248 |
| Crimp/Weld/Bond | 2 |
| Other | 24 |
WW Returned Product Analysis
| Conductor Fracture | 165 |
|---|---|
| Insulation Breach | 262 |
| 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 June 8, 2026