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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.8 | 98.5 | 98.5 | 98.5 | 97.6 | 97.6 | |||||||
| # | 1393 | 1227 | 1063 | 903 | 731 | 640 | 528 | 424 | 358 | 295 | 233 | 138 | 104 | 63 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1713 |
|---|---|
| Cumulative Months of Follow-Up | 106524 |
| Number of Leads Active in Study | 408 |
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 | at 174.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.7 | 99.6 | 99.5 | 99.3 | 98.9 | 98.8 | 98.7 | 98.7 | 98.7 | 98.3 | 98.3 | 98.3 | 96.5 | 96.5 | ||||||
| # | 3128 | 2691 | 2317 | 2050 | 1756 | 1502 | 1277 | 992 | 751 | 594 | 417 | 229 | 153 | 83 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 4115 |
|---|---|
| Cumulative Months of Follow-Up | 235332 |
| Number of Leads Active in Study | 1503 |
33
Qualifying Complications
| Cardiac Perforation | 3 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 10 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 9 |
| Oversensing | 1 |
| Other | 3 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 192 |
|---|---|
| Conductor Fracture | 10 |
| Extra Cardiac Stimulation | 25 |
| Failure to Capture | 266 |
| Failure to Sense | 115 |
| Impedance Out of Range | 44 |
| Insulation Breach | 1 |
| Lead Dislodgement | 713 |
| Oversensing | 94 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 729812 |
| Estimated Active USA Implants | 397689 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1707027 |
USA Returned Product Analysis
| Conductor Fracture | 115 |
|---|---|
| Insulation Breach | 186 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
WW Returned Product Analysis
| Conductor Fracture | 136 |
|---|---|
| Insulation Breach | 195 |
| 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 December 16, 2021