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 | 18 yr | at 222.0 mo | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 99.0 | 98.8 | 98.5 | 98.3 | 98.0 | 97.6 | 97.6 | 97.3 | 97.3 | 96.5 | 95.4 | 95.4 | 95.4 | 95.4 | 95.4 | 95.4 | ||
| # | 2239 | 1909 | 1589 | 1300 | 1047 | 846 | 701 | 591 | 511 | 443 | 337 | 270 | 198 | 161 | 132 | 110 | 86 | 59 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 3408 |
|---|---|
| Cumulative Months of Follow-Up | 166524 |
| Number of Leads Active in Study | 686 |
37
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 8 |
| Failure to Capture | 13 |
| Failure to Sense | 1 |
| Impedance Out of Range | 4 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 5 |
| Oversensing | 2 |
| 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 | 20 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.5 | 99.3 | 99.1 | 98.8 | 98.6 | 98.5 | 98.3 | 98.3 | 98.2 | 98.2 | 98.0 | 97.7 | 97.2 | 97.1 | 97.1 | 96.8 | 96.8 | 96.8 | 96.8 | |
| # | 8936 | 7180 | 6049 | 5075 | 4232 | 3558 | 2922 | 2292 | 1845 | 1489 | 1139 | 911 | 710 | 547 | 437 | 358 | 266 | 175 | 108 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 13795 |
|---|---|
| Cumulative Months of Follow-Up | 638304 |
| Number of Leads Active in Study | 5639 |
116
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 13 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 18 |
| Failure to Sense | 11 |
| Impedance Out of Range | 13 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 42 |
| Oversensing | 3 |
| Other | 8 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1680 |
|---|---|
| Conductor Fracture | 33 |
| Extra Cardiac Stimulation | 114 |
| Failure to Capture | 2539 |
| Failure to Sense | 1600 |
| Impedance Out of Range | 426 |
| Insulation Breach | 16 |
| Lead Dislodgement | 5366 |
| Oversensing | 885 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 3351058 |
| Estimated Active USA Implants | 1888453 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 8654767 |
USA Returned Product Analysis
| Conductor Fracture | 1510 |
|---|---|
| Insulation Breach | 1611 |
| Crimp/Weld/Bond | 4 |
| Other | 205 |
WW Returned Product Analysis
| Conductor Fracture | 1711 |
|---|---|
| Insulation Breach | 1751 |
| Crimp/Weld/Bond | 4 |
| Other | 250 |
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 April 30, 2024