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 | at 222.0 mo | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 99.0 | 98.9 | 98.5 | 98.2 | 97.9 | 97.6 | 97.6 | 97.3 | 97.3 | 96.5 | 95.4 | 95.4 | 95.4 | 95.4 | 95.4 | 95.4 | ||
| # | 2256 | 1929 | 1627 | 1343 | 1108 | 883 | 724 | 605 | 527 | 456 | 353 | 279 | 207 | 167 | 138 | 118 | 90 | 66 | 57 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3431 |
|---|---|
| Cumulative Months of Follow-Up | 170887 |
| Number of Leads Active in Study | 578 |
38
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 9 |
| Failure to Capture | 13 |
| Failure to Sense | 1 |
| Impedance Out of Range | 4 |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.4 | 99.3 | 99.1 | 98.8 | 98.6 | 98.4 | 98.3 | 98.3 | 98.2 | 98.2 | 98.0 | 97.8 | 97.3 | 97.1 | 97.1 | 96.9 | 96.9 | 96.9 | 96.9 | |
| # | 9581 | 7580 | 6305 | 5300 | 4416 | 3686 | 3096 | 2458 | 1948 | 1579 | 1236 | 953 | 748 | 577 | 458 | 381 | 291 | 200 | 118 | 68 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 14182 |
|---|---|
| Cumulative Months of Follow-Up | 673573 |
| Number of Leads Active in Study | 5402 |
123
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 13 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 18 |
| Failure to Sense | 12 |
| Impedance Out of Range | 13 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 47 |
| Oversensing | 3 |
| Other | 9 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1746 |
|---|---|
| Conductor Fracture | 35 |
| Extra Cardiac Stimulation | 115 |
| Failure to Capture | 2722 |
| Failure to Sense | 1723 |
| Impedance Out of Range | 468 |
| Insulation Breach | 16 |
| Lead Dislodgement | 5589 |
| Oversensing | 976 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 3442082 |
| Estimated Active USA Implants | 1961260 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 9045635 |
USA Returned Product Analysis
| Conductor Fracture | 1571 |
|---|---|
| Insulation Breach | 1666 |
| Crimp/Weld/Bond | 4 |
| Other | 206 |
WW Returned Product Analysis
| Conductor Fracture | 1782 |
|---|---|
| Insulation Breach | 1811 |
| Crimp/Weld/Bond | 4 |
| Other | 251 |
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 November 20, 2024