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 | at 138.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.7 | 98.7 | 98.7 | 98.7 | |||||||||
| # | 1326 | 1174 | 1044 | 885 | 685 | 550 | 433 | 341 | 219 | 142 | 97 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1602 |
|---|---|
| Cumulative Months of Follow-Up | 92375 |
| Number of Leads Active in Study | 442 |
11
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 5 |
| 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 | at 138.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.6 | 99.6 | 99.4 | 99.3 | 98.9 | 98.7 | 98.7 | 98.7 | 98.7 | 98.7 | 98.7 | |||||||||
| # | 2970 | 2587 | 2242 | 1862 | 1426 | 983 | 709 | 489 | 285 | 162 | 95 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3584 |
|---|---|
| Cumulative Months of Follow-Up | 185977 |
| Number of Leads Active in Study | 1480 |
24
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 7 |
| Failure to Sense | 3 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 7 |
| Oversensing | 1 |
| Other | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 122 |
|---|---|
| Conductor Fracture | 6 |
| Extra Cardiac Stimulation | 17 |
| Failure to Capture | 159 |
| Failure to Sense | 63 |
| Impedance Out of Range | 26 |
| Insulation Breach | 1 |
| Lead Dislodgement | 429 |
| Oversensing | 48 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 617699 |
| Estimated Active USA Implants | 432695 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1350790 |
USA Returned Product Analysis
| Conductor Fracture | 93 |
|---|---|
| Insulation Breach | 132 |
| Crimp/Weld/Bond | 1 |
| Other | 20 |
WW Returned Product Analysis
| Conductor Fracture | 109 |
|---|---|
| Insulation Breach | 138 |
| Crimp/Weld/Bond | 1 |
| Other | 27 |
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 11, 2019