5534
CapSure Z
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 78 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.3 | 97.8 | 97.8 | 97.1 | 97.1 | 97.1 | 97.1 | |||
| # | 207 | 182 | 155 | 108 | 72 | 56 | 51 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 264 |
|---|---|
| Cumulative Months of Follow-Up | 13009 |
| Number of Leads Active in Study | 6 |
6
Qualifying Complications
| Failure to Capture | 5 |
|---|---|
| Impedance Out of Range | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Lead Dislodgement | 6 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 1996-02-09 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 25776 |
| Estimated Active USA Implants | 6800 |
| US Market Release | 1996-02-09 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 30752 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 6 |
|---|---|
| Insulation Breach | 6 |
| Crimp/Weld/Bond | 0 |
| Other | 7 |
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 | LDG |
|---|---|
| Lead Body Diameter | 7.8 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013