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 | 98.4 | 98.3 | 97.8 | 97.3 | 97.3 | 97.0 | 97.0 | 96.4 | 95.6 | 95.6 | 95.6 | |||||
| # | 1929 | 1490 | 1205 | 976 | 836 | 703 | 526 | 421 | 362 | 305 | 251 | 201 | 150 | 115 | 79 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3108 |
|---|---|
| Cumulative Months of Follow-Up | 129553 |
| Number of Leads Active in Study | 934 |
31
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 | 1 |
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
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 | 97.3 | 97.3 | 97.3 | 97.3 | ||||
| # | 6521 | 5407 | 4548 | 3605 | 2869 | 2366 | 1872 | 1489 | 1239 | 999 | 805 | 644 | 489 | 330 | 206 | 132 | 69 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 9874 |
|---|---|
| Cumulative Months of Follow-Up | 446886 |
| Number of Leads Active in Study | 4321 |
86
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 14 |
| Failure to Sense | 6 |
| Impedance Out of Range | 7 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 31 |
| Oversensing | 4 |
| Other | 5 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1212 |
|---|---|
| Conductor Fracture | 25 |
| Extra Cardiac Stimulation | 92 |
| Failure to Capture | 1513 |
| Failure to Sense | 632 |
| Impedance Out of Range | 192 |
| Insulation Breach | 11 |
| Lead Dislodgement | 3752 |
| Oversensing | 473 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2777413 |
| Estimated Active USA Implants | 1841973 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 6547727 |
USA Returned Product Analysis
| Conductor Fracture | 1146 |
|---|---|
| Insulation Breach | 1223 |
| Crimp/Weld/Bond | 0 |
| Other | 185 |
WW Returned Product Analysis
| Conductor Fracture | 1300 |
|---|---|
| Insulation Breach | 1335 |
| Crimp/Weld/Bond | 0 |
| Other | 228 |
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 29, 2020