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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.7 | 99.6 | 99.4 | 99.4 | 99.0 | 99.0 | 98.7 | 98.7 | 98.7 | 98.7 | |||||||||
| # | 1346 | 1181 | 1050 | 894 | 716 | 561 | 443 | 352 | 266 | 149 | 113 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1654 |
|---|---|
| Cumulative Months of Follow-Up | 95308 |
| Number of Leads Active in Study | 470 |
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 | 99.7 | 99.6 | 99.5 | 99.3 | 98.9 | 98.7 | 98.7 | 98.7 | 98.7 | 98.7 | 98.7 | |||||||||
| # | 3056 | 2661 | 2297 | 1943 | 1532 | 1109 | 770 | 553 | 365 | 177 | 115 | 83 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3798 |
|---|---|
| Cumulative Months of Follow-Up | 196650 |
| Number of Leads Active in Study | 1584 |
25
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 8 |
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 7 |
| Oversensing | 1 |
| Other | 1 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 142 |
|---|---|
| Conductor Fracture | 7 |
| Extra Cardiac Stimulation | 19 |
| Failure to Capture | 177 |
| Failure to Sense | 77 |
| Impedance Out of Range | 30 |
| Insulation Breach | 1 |
| Lead Dislodgement | 475 |
| Oversensing | 56 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Registered USA Implants | 641740 |
| Estimated Active USA Implants | 448094 |
| US Market Release | 2004-02-25 |
|---|---|
| CE Approval Date | 2004-06-14 |
| Estimated WW Distribution | 1420698 |
USA Returned Product Analysis
| Conductor Fracture | 97 |
|---|---|
| Insulation Breach | 140 |
| Crimp/Weld/Bond | 1 |
| Other | 20 |
WW Returned Product Analysis
| Conductor Fracture | 116 |
|---|---|
| Insulation Breach | 147 |
| 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 November 8, 2019