5033
CapSure Z
ALL
Device Survival Probability
| 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 177 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.6 | 99.1 | 99.0 | 98.8 | 98.3 | 97.7 | 96.9 | 96.0 | 96.0 | 95.6 | 95.6 | 94.9 | 93.9 | 93.9 | ||||||
| # | 1415 | 1143 | 944 | 795 | 658 | 527 | 416 | 347 | 290 | 240 | 188 | 153 | 126 | 78 | 45 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1899 |
|---|---|
| Cumulative Months of Follow-Up | 100842 |
| Number of Leads Active in Study | 148 |
29
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 8 |
| Failure to Capture | 13 |
| Impedance Out of Range | 4 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Unspecified Clinical Failure | 1 |
|---|
Distribution Data
| US Market Release | 1996-02-09 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 2336 |
| Estimated Active USA Implants | 479 |
| US Market Release | 1996-02-09 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 9278 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
WW Returned Product Analysis
| Conductor Fracture | 2 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | Unipolar |
| Serial Number Prefix | LDK |
|---|---|
| Lead Body Diameter | 5.1 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013