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 | 17 yr | at 210.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.4 | 99.3 | 99.1 | 99.0 | 98.6 | 98.5 | 98.2 | 97.8 | 97.8 | 97.5 | 97.5 | 97.0 | 95.8 | 95.8 | 95.8 | 95.8 | 95.8 | |||
| # | 2197 | 1837 | 1507 | 1173 | 954 | 798 | 668 | 562 | 470 | 381 | 312 | 248 | 178 | 145 | 125 | 104 | 72 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3355 |
|---|---|
| Cumulative Months of Follow-Up | 156992 |
| Number of Leads Active in Study | 799 |
32
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 6 |
| Failure to Capture | 12 |
| Failure to Sense | 1 |
| Impedance Out of Range | 4 |
| 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 | 18 yr | 19 yr | at 234.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.4 | 99.3 | 99.1 | 98.8 | 98.6 | 98.4 | 98.3 | 98.3 | 98.2 | 98.1 | 97.9 | 97.6 | 97.3 | 97.1 | 97.1 | 96.7 | 96.7 | 96.7 | 96.7 | |
| # | 7992 | 6675 | 5634 | 4679 | 3944 | 3219 | 2531 | 2055 | 1681 | 1293 | 1045 | 833 | 632 | 501 | 395 | 295 | 193 | 123 | 70 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 12432 |
|---|---|
| Cumulative Months of Follow-Up | 578296 |
| Number of Leads Active in Study | 5235 |
108
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 13 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 17 |
| Failure to Sense | 9 |
| Impedance Out of Range | 11 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 39 |
| Oversensing | 3 |
| Other | 8 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1544 |
|---|---|
| Conductor Fracture | 31 |
| Extra Cardiac Stimulation | 110 |
| Failure to Capture | 2245 |
| Failure to Sense | 1124 |
| Impedance Out of Range | 367 |
| Insulation Breach | 15 |
| Lead Dislodgement | 4925 |
| Oversensing | 724 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 3204116 |
| Estimated Active USA Implants | 1770880 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 8097571 |
USA Returned Product Analysis
| Conductor Fracture | 1415 |
|---|---|
| Insulation Breach | 1524 |
| Crimp/Weld/Bond | 3 |
| Other | 199 |
WW Returned Product Analysis
| Conductor Fracture | 1610 |
|---|---|
| Insulation Breach | 1660 |
| Crimp/Weld/Bond | 3 |
| Other | 243 |
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 May 10, 2023