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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.3 | 99.3 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 98.1 | 98.1 | 98.1 | 96.7 | |||||
| # | 1451 | 1296 | 1145 | 985 | 785 | 672 | 564 | 485 | 421 | 350 | 283 | 228 | 191 | 131 | 91 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1770 |
|---|---|
| Cumulative Months of Follow-Up | 119246 |
| Number of Leads Active in Study | 318 |
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 | at 198.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.7 | 99.6 | 99.6 | 99.5 | 99.4 | 99.0 | 98.9 | 98.8 | 98.8 | 98.8 | 98.5 | 98.5 | 98.2 | 97.2 | 97.2 | 97.2 | 97.2 | ||||
| # | 3517 | 3022 | 2647 | 2298 | 1916 | 1650 | 1451 | 1266 | 1064 | 846 | 615 | 459 | 341 | 210 | 141 | 89 | 63 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4928 |
|---|---|
| Cumulative Months of Follow-Up | 281736 |
| Number of Leads Active in Study | 1759 |
38
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 3 |
| Failure to Capture | 9 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 14 |
| Oversensing | 2 |
| Other | 2 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 261 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 27 |
| Failure to Capture | 396 |
| Failure to Sense | 288 |
| Impedance Out of Range | 76 |
| Insulation Breach | 2 |
| Lead Dislodgement | 913 |
| Oversensing | 150 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 819485 |
| Estimated Active USA Implants | 474265 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 2090057 |
USA Returned Product Analysis
| Conductor Fracture | 130 |
|---|---|
| Insulation Breach | 222 |
| Crimp/Weld/Bond | 2 |
| Other | 23 |
WW Returned Product Analysis
| Conductor Fracture | 154 |
|---|---|
| Insulation Breach | 233 |
| Crimp/Weld/Bond | 2 |
| Other | 33 |
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 April 30, 2024