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 | at 198.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 99.1 | 98.9 | 98.5 | 98.4 | 97.8 | 97.3 | 97.3 | 97.0 | 97.0 | 96.5 | 95.1 | 95.1 | 95.1 | 95.1 | ||||
| # | 2086 | 1662 | 1295 | 1029 | 876 | 745 | 621 | 474 | 387 | 341 | 272 | 215 | 161 | 133 | 102 | 72 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3230 |
|---|---|
| Cumulative Months of Follow-Up | 141203 |
| Number of Leads Active in Study | 914 |
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 | 18 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.4 | 99.3 | 99.1 | 98.8 | 98.7 | 98.4 | 98.3 | 98.3 | 98.2 | 98.1 | 97.8 | 97.7 | 97.3 | 97.0 | 97.0 | 97.0 | 97.0 | |||
| # | 7143 | 5928 | 4940 | 4123 | 3314 | 2617 | 2176 | 1699 | 1358 | 1114 | 897 | 705 | 560 | 425 | 290 | 186 | 117 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 10619 |
|---|---|
| Cumulative Months of Follow-Up | 497965 |
| Number of Leads Active in Study | 4416 |
95
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 15 |
| Failure to Sense | 9 |
| Impedance Out of Range | 7 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 34 |
| Oversensing | 5 |
| Other | 6 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1367 |
|---|---|
| Conductor Fracture | 27 |
| Extra Cardiac Stimulation | 100 |
| Failure to Capture | 1795 |
| Failure to Sense | 795 |
| Impedance Out of Range | 266 |
| Insulation Breach | 11 |
| Lead Dislodgement | 4365 |
| Oversensing | 595 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2968831 |
| Estimated Active USA Implants | 1581352 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 7278066 |
USA Returned Product Analysis
| Conductor Fracture | 1273 |
|---|---|
| Insulation Breach | 1375 |
| Crimp/Weld/Bond | 1 |
| Other | 190 |
WW Returned Product Analysis
| Conductor Fracture | 1450 |
|---|---|
| Insulation Breach | 1502 |
| Crimp/Weld/Bond | 1 |
| Other | 236 |
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 December 16, 2021