5076
CapSureFix Novus
VENTRICULAR PLACEMENT
Device Survival Probability
5076_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 | 18 yr | 19 yr | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 98.9 | 98.8 | 98.4 | 98.2 | 97.9 | 97.6 | 97.6 | 97.3 | 97.3 | 96.6 | 95.6 | 95.6 | 95.6 | 95.6 | 95.6 | 95.6 | ||
| # | 2282 | 1977 | 1690 | 1434 | 1211 | 990 | 778 | 640 | 546 | 474 | 394 | 311 | 223 | 187 | 153 | 130 | 100 | 76 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3437 |
|---|---|
| Cumulative Months of Follow-Up | 179932 |
| Number of Leads Active in Study | 405 |
41
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 10 |
| Failure to Capture | 13 |
| Failure to Sense | 1 |
| Impedance Out of Range | 6 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 5 |
| Oversensing | 2 |
| Other | 2 |
ATRIAL PLACEMENT
Device Survival Probability
5076_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 | 19 yr | 20 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.5 | 99.4 | 99.2 | 99.1 | 98.8 | 98.6 | 98.4 | 98.2 | 98.1 | 98.0 | 98.0 | 97.8 | 97.6 | 97.2 | 97.0 | 97.0 | 96.6 | 96.6 | 96.6 | 96.6 | |
| # | 10701 | 8848 | 7198 | 5903 | 4899 | 4085 | 3386 | 2845 | 2310 | 1788 | 1434 | 1121 | 821 | 647 | 522 | 429 | 343 | 268 | 184 | 104 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 14218 |
|---|---|
| Cumulative Months of Follow-Up | 761016 |
| Number of Leads Active in Study | 3999 |
148
Qualifying Complications
| Cardiac Perforation | 3 |
|---|---|
| Conductor Fracture | 16 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 24 |
| Failure to Sense | 14 |
| Impedance Out of Range | 13 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 59 |
| Oversensing | 4 |
| Other | 10 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1961 |
|---|---|
| Conductor Fracture | 42 |
| Extra Cardiac Stimulation | 123 |
| Failure to Capture | 3308 |
| Failure to Sense | 1972 |
| Impedance Out of Range | 614 |
| Insulation Breach | 18 |
| Lead Dislodgement | 6189 |
| Oversensing | 1179 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 3648240 |
| Estimated Active USA Implants | 2121583 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 10030914 |
USA Returned Product Analysis
| Conductor Fracture | 1744 |
|---|---|
| Insulation Breach | 1820 |
| Crimp/Weld/Bond | 4 |
| Other | 209 |
WW Returned Product Analysis
| Conductor Fracture | 1977 |
|---|---|
| Insulation Breach | 1977 |
| Crimp/Weld/Bond | 4 |
| Other | 254 |
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 | PJN |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of June 8, 2026