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 | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 99.0 | 98.8 | 98.3 | 98.1 | 97.6 | 97.1 | 97.1 | 96.7 | 96.7 | 96.0 | 96.0 | |||||||
| # | 1785 | 1448 | 1191 | 968 | 755 | 520 | 415 | 320 | 237 | 198 | 164 | 123 | 84 | 68 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2819 |
|---|---|
| Cumulative Months of Follow-Up | 112827 |
| Number of Leads Active in Study | 869 |
29
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 6 |
| Failure to Capture | 11 |
| Failure to Sense | 1 |
| Impedance Out of Range | 4 |
| Lead Dislodgement | 4 |
| 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 | at 174.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.5 | 99.4 | 99.1 | 98.8 | 98.6 | 98.4 | 98.2 | 98.2 | 98.1 | 98.0 | 97.8 | 97.8 | 97.4 | 97.4 | ||||||
| # | 6444 | 5191 | 4029 | 3184 | 2432 | 1648 | 1232 | 896 | 628 | 472 | 370 | 274 | 164 | 90 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 8774 |
|---|---|
| Cumulative Months of Follow-Up | 370123 |
| Number of Leads Active in Study | 4063 |
68
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 12 |
| Failure to Sense | 5 |
| Impedance Out of Range | 6 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 21 |
| Oversensing | 3 |
| Other | 4 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 956 |
|---|---|
| Conductor Fracture | 22 |
| Extra Cardiac Stimulation | 72 |
| Failure to Capture | 1147 |
| Failure to Sense | 414 |
| Impedance Out of Range | 101 |
| Insulation Breach | 10 |
| Lead Dislodgement | 2901 |
| Oversensing | 341 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2522836 |
| Estimated Active USA Implants | 1683781 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 5800321 |
USA Returned Product Analysis
| Conductor Fracture | 992 |
|---|---|
| Insulation Breach | 1027 |
| Crimp/Weld/Bond | 0 |
| Other | 175 |
WW Returned Product Analysis
| Conductor Fracture | 1119 |
|---|---|
| Insulation Breach | 1122 |
| Crimp/Weld/Bond | 0 |
| Other | 218 |
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 11, 2019