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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.8 | 98.8 | 98.8 | 98.8 | 97.6 | ||||||||
| # | 1359 | 1174 | 1042 | 888 | 723 | 623 | 484 | 406 | 340 | 254 | 169 | 116 | 66 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1684 |
|---|---|
| Cumulative Months of Follow-Up | 101093 |
| Number of Leads Active in Study | 444 |
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 | 12 yr | 13 yr | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.8 | 99.7 | 99.6 | 99.5 | 99.3 | 98.9 | 98.7 | 98.6 | 98.6 | 98.6 | 98.3 | 98.3 | 98.3 | 98.3 | |||||||
| # | 2934 | 2531 | 2243 | 1967 | 1667 | 1399 | 1082 | 841 | 661 | 467 | 283 | 167 | 92 | 66 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3958 |
|---|---|
| Cumulative Months of Follow-Up | 215523 |
| Number of Leads Active in Study | 1538 |
29
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 10 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 8 |
| Oversensing | 1 |
| Other | 2 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 164 |
|---|---|
| Conductor Fracture | 10 |
| Extra Cardiac Stimulation | 23 |
| Failure to Capture | 220 |
| Failure to Sense | 91 |
| Impedance Out of Range | 37 |
| Insulation Breach | 1 |
| Lead Dislodgement | 583 |
| Oversensing | 76 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 678898 |
| Estimated Active USA Implants | 464630 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1523150 |
USA Returned Product Analysis
| Conductor Fracture | 106 |
|---|---|
| Insulation Breach | 162 |
| Crimp/Weld/Bond | 1 |
| Other | 20 |
WW Returned Product Analysis
| Conductor Fracture | 125 |
|---|---|
| Insulation Breach | 169 |
| 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 October 29, 2020