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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.1 | 99.1 | 98.8 | 98.6 | 98.6 | 98.6 | 97.9 | 97.9 | 97.9 | ||||||
| # | 1419 | 1263 | 1104 | 927 | 750 | 653 | 548 | 468 | 380 | 315 | 258 | 191 | 124 | 97 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1745 |
|---|---|
| Cumulative Months of Follow-Up | 112061 |
| Number of Leads Active in Study | 390 |
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 | 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 | 97.2 | 97.2 | 97.2 | |||||
| # | 3252 | 2847 | 2450 | 2121 | 1824 | 1574 | 1377 | 1165 | 910 | 680 | 511 | 343 | 206 | 135 | 75 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4375 |
|---|---|
| Cumulative Months of Follow-Up | 254642 |
| Number of Leads Active in Study | 1565 |
34
Qualifying Complications
| Cardiac Perforation | 3 |
|---|---|
| Conductor Fracture | 3 |
| Failure to Capture | 10 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 10 |
| Oversensing | 1 |
| Other | 2 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 224 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 27 |
| Failure to Capture | 310 |
| Failure to Sense | 148 |
| Impedance Out of Range | 57 |
| Insulation Breach | 2 |
| Lead Dislodgement | 776 |
| Oversensing | 105 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 753447 |
| Estimated Active USA Implants | 418708 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1857071 |
USA Returned Product Analysis
| Conductor Fracture | 124 |
|---|---|
| Insulation Breach | 202 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
WW Returned Product Analysis
| Conductor Fracture | 146 |
|---|---|
| Insulation Breach | 213 |
| 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 November 29, 2022