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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 99.0 | 98.8 | 98.3 | 98.2 | 97.7 | 97.2 | 97.2 | 96.8 | 96.8 | 96.2 | 95.1 | |||||||
| # | 1893 | 1474 | 1219 | 982 | 810 | 560 | 430 | 330 | 248 | 201 | 164 | 126 | 90 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2986 |
|---|---|
| Cumulative Months of Follow-Up | 117944 |
| Number of Leads Active in Study | 959 |
30
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 6 |
| Failure to Capture | 12 |
| 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 | 15 yr | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.5 | 99.4 | 99.1 | 98.8 | 98.6 | 98.4 | 98.3 | 98.3 | 98.1 | 98.0 | 97.9 | 97.9 | 97.5 | 97.5 | ||||||
| # | 6749 | 5518 | 4363 | 3369 | 2657 | 1833 | 1313 | 972 | 686 | 478 | 372 | 289 | 182 | 109 | 62 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 9277 |
|---|---|
| Cumulative Months of Follow-Up | 395281 |
| Number of Leads Active in Study | 4294 |
74
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 12 |
| Failure to Sense | 5 |
| Impedance Out of Range | 6 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 26 |
| Oversensing | 3 |
| Other | 4 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 1069 |
|---|---|
| Conductor Fracture | 22 |
| Extra Cardiac Stimulation | 80 |
| Failure to Capture | 1288 |
| Failure to Sense | 495 |
| Impedance Out of Range | 135 |
| Insulation Breach | 11 |
| Lead Dislodgement | 3252 |
| Oversensing | 400 |
| Unspecified Clinical Failure | 26 |
Distribution Data
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Registered USA Implants | 2627903 |
| Estimated Active USA Implants | 1755185 |
| US Market Release | 2000-08-31 |
|---|---|
| CE Approval Date | 1999-08-12 |
| Estimated WW Distribution | 6130288 |
USA Returned Product Analysis
| Conductor Fracture | 1061 |
|---|---|
| Insulation Breach | 1097 |
| Crimp/Weld/Bond | 0 |
| Other | 176 |
WW Returned Product Analysis
| Conductor Fracture | 1203 |
|---|---|
| Insulation Breach | 1202 |
| Crimp/Weld/Bond | 0 |
| Other | 219 |
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 November 8, 2019