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 | 99.0 | 98.7 | 98.2 | 98.0 | 97.5 | 96.9 | 96.9 | 96.4 | 96.4 | 95.7 | ||||||||
| # | 1715 | 1395 | 1137 | 840 | 596 | 485 | 395 | 298 | 234 | 198 | 159 | 109 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2522 |
|---|---|
| Cumulative Months of Follow-Up | 104025 |
| Number of Leads Active in Study | 720 |
27
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 6 |
| 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 | 14 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.6 | 99.4 | 99.2 | 98.9 | 98.6 | 98.6 | 98.4 | 98.4 | 98.3 | 98.1 | 98.0 | 98.0 | 97.3 | |||||||
| # | 5798 | 4469 | 3569 | 2739 | 1940 | 1463 | 1081 | 775 | 586 | 464 | 340 | 205 | 114 | 57 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 7984 |
|---|---|
| Cumulative Months of Follow-Up | 324408 |
| Number of Leads Active in Study | 3806 |
56
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 10 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 8 |
| Failure to Sense | 4 |
| Impedance Out of Range | 6 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 16 |
| 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 | 788 |
|---|---|
| Conductor Fracture | 21 |
| Extra Cardiac Stimulation | 58 |
| Failure to Capture | 879 |
| Failure to Sense | 280 |
| Impedance Out of Range | 58 |
| Insulation Breach | 9 |
| Lead Dislodgement | 2303 |
| Oversensing | 218 |
| Unspecified Clinical Failure | 31 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2346371 |
| Estimated Active USA Implants | 1528342 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 5265491 |
USA Returned Product Analysis
| Conductor Fracture | 873 |
|---|---|
| Insulation Breach | 904 |
| Crimp/Weld/Bond | 0 |
| Other | 223 |
WW Returned Product Analysis
| Conductor Fracture | 988 |
|---|---|
| Insulation Breach | 976 |
| Crimp/Weld/Bond | 0 |
| Other | 331 |
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 January 31, 2018