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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 98.9 | 98.9 | 98.4 | 98.1 | 97.6 | 97.0 | 97.0 | 96.5 | 96.5 | 95.5 | ||||||||
| # | 1653 | 1337 | 1021 | 683 | 557 | 457 | 362 | 292 | 231 | 187 | 145 | 93 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2346 |
|---|---|
| Cumulative Months of Follow-Up | 96740 |
| Number of Leads Active in Study | 645 |
25
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 4 |
| Failure to Capture | 10 |
| Failure to Sense | 1 |
| Impedance Out of Range | 4 |
| Lead Dislodgement | 3 |
| 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 | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.5 | 99.4 | 99.2 | 98.9 | 98.7 | 98.6 | 98.5 | 98.5 | 98.4 | 98.4 | 98.1 | 98.1 | 98.1 | |||||||
| # | 4962 | 3891 | 3021 | 2123 | 1652 | 1236 | 922 | 721 | 570 | 414 | 266 | 150 | 81 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 7272 |
|---|---|
| Cumulative Months of Follow-Up | 275934 |
| Number of Leads Active in Study | 3763 |
46
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 8 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 8 |
| Failure to Sense | 2 |
| Impedance Out of Range | 4 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 15 |
| Oversensing | 2 |
| Other | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 600 |
|---|---|
| Conductor Fracture | 21 |
| Extra Cardiac Stimulation | 48 |
| Failure to Capture | 676 |
| Failure to Sense | 173 |
| Impedance Out of Range | 44 |
| Insulation Breach | 9 |
| Lead Dislodgement | 1760 |
| Oversensing | 136 |
| Unspecified Clinical Failure | 31 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2133965 |
| Estimated Active USA Implants | 1348691 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 4653655 |
USA Returned Product Analysis
| Conductor Fracture | 750 |
|---|---|
| Insulation Breach | 749 |
| Crimp/Weld/Bond | 0 |
| Other | 205 |
WW Returned Product Analysis
| Conductor Fracture | 845 |
|---|---|
| Insulation Breach | 810 |
| Crimp/Weld/Bond | 0 |
| Other | 309 |
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 February 3, 2017