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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.8 | 99.8 | 99.8 | 99.7 | 99.4 | 99.4 | 99.0 | 99.0 | 98.7 | 98.7 | 98.7 | ||||||||||
| # | 1319 | 1167 | 1039 | 869 | 653 | 542 | 427 | 317 | 192 | 120 | 73 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1570 |
|---|---|
| Cumulative Months of Follow-Up | 89859 |
| Number of Leads Active in Study | 443 |
10
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 4 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 1 |
| Other | 1 |
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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.7 | 99.6 | 99.5 | 99.4 | 99.0 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | ||||||||||
| # | 2897 | 2519 | 2169 | 1768 | 1288 | 905 | 652 | 425 | 227 | 132 | 63 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3453 |
|---|---|
| Cumulative Months of Follow-Up | 176180 |
| Number of Leads Active in Study | 1467 |
19
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 5 |
| Failure to Sense | 3 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 5 |
| Oversensing | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 111 |
|---|---|
| Conductor Fracture | 6 |
| Extra Cardiac Stimulation | 17 |
| Failure to Capture | 145 |
| Failure to Sense | 57 |
| Impedance Out of Range | 24 |
| Insulation Breach | 1 |
| Lead Dislodgement | 376 |
| Oversensing | 42 |
| Unspecified Clinical Failure | 12 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 598958 |
| Estimated Active USA Implants | 416122 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1296762 |
USA Returned Product Analysis
| Conductor Fracture | 89 |
|---|---|
| Insulation Breach | 124 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
WW Returned Product Analysis
| Conductor Fracture | 105 |
|---|---|
| Insulation Breach | 130 |
| Crimp/Weld/Bond | 1 |
| Other | 36 |
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 October 12, 2018