5076
CapSureFix Novus
VENTRICULAR PLACEMENT
Device Survival Probability
5076_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 | 15 yr | 16 yr | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 99.0 | 98.8 | 98.5 | 98.3 | 97.7 | 97.2 | 97.2 | 96.8 | 96.8 | 96.3 | 94.8 | 94.8 | 94.8 | |||||
| # | 2011 | 1564 | 1234 | 1000 | 854 | 725 | 574 | 431 | 371 | 323 | 260 | 206 | 156 | 122 | 92 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3164 |
|---|---|
| Cumulative Months of Follow-Up | 134658 |
| Number of Leads Active in Study | 921 |
33
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 6 |
| Failure to Capture | 12 |
| Failure to Sense | 1 |
| Impedance Out of Range | 5 |
| Lead Dislodgement | 5 |
| Oversensing | 1 |
| Other | 2 |
ATRIAL PLACEMENT
Device Survival Probability
5076_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 | 15 yr | 16 yr | 17 yr | at 210.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.5 | 99.4 | 99.1 | 98.8 | 98.6 | 98.4 | 98.2 | 98.2 | 98.1 | 98.0 | 97.7 | 97.6 | 97.1 | 97.1 | 97.1 | 97.1 | 97.1 | |||
| # | 6821 | 5631 | 4724 | 3860 | 3067 | 2474 | 2028 | 1558 | 1289 | 1052 | 842 | 671 | 524 | 376 | 245 | 153 | 93 | 65 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 10191 |
|---|---|
| Cumulative Months of Follow-Up | 469651 |
| Number of Leads Active in Study | 4323 |
91
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 14 |
| Failure to Sense | 7 |
| Impedance Out of Range | 7 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 33 |
| Oversensing | 5 |
| Other | 6 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1343 |
|---|---|
| Conductor Fracture | 26 |
| Extra Cardiac Stimulation | 99 |
| Failure to Capture | 1753 |
| Failure to Sense | 771 |
| Impedance Out of Range | 256 |
| Insulation Breach | 11 |
| Lead Dislodgement | 4308 |
| Oversensing | 580 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2942052 |
| Estimated Active USA Implants | 1559626 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 7191386 |
USA Returned Product Analysis
| Conductor Fracture | 1259 |
|---|---|
| Insulation Breach | 1355 |
| Crimp/Weld/Bond | 1 |
| Other | 189 |
WW Returned Product Analysis
| Conductor Fracture | 1434 |
|---|---|
| Insulation Breach | 1480 |
| Crimp/Weld/Bond | 1 |
| Other | 235 |
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 | PJN |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of October 11, 2021