5554
CapSure Z Novus
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 78 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 99.2 | 98.7 | 98.2 | 98.2 | 98.2 | 98.2 | |||
| # | 273 | 227 | 182 | 159 | 137 | 80 | 49 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 344 |
|---|---|
| Cumulative Months of Follow-Up | 15784 |
| Number of Leads Active in Study | 35 |
4
Qualifying Complications
| Failure to Capture | 1 |
|---|---|
| Impedance Out of Range | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 25 |
| Failure to Sense | 2 |
| Lead Dislodgement | 29 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-06-05 |
| Registered USA Implants | 62013 |
| Estimated Active USA Implants | 29209 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-06-05 |
| Estimated WW Distribution | 220963 |
USA Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 18 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 36 |
|---|---|
| Insulation Breach | 25 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LEJ |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013