5038
CapSure VDD-2
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | at 81 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.8 | 99.8 | 99.8 | 98.8 | 98.2 | 98.2 | 95.2 | |||
| # | 420 | 308 | 220 | 176 | 135 | 83 | 52 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 558 |
|---|---|
| Cumulative Months of Follow-Up | 20718 |
| Number of Leads Active in Study | 51 |
6
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 1 |
| Failure to Sense | 2 |
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 | 1 |
| Failure to Sense | 1 |
| Lead Dislodgement | 2 |
Distribution Data
| US Market Release | 1998-09-10 |
|---|---|
| CE Approval Date | 1997-04-15 |
| Registered USA Implants | 9093 |
| Estimated Active USA Implants | 3527 |
| US Market Release | 1998-09-10 |
|---|---|
| CE Approval Date | 1997-04-15 |
| Estimated WW Distribution | 111854 |
USA Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 14 |
|---|---|
| Insulation Breach | 10 |
| Crimp/Weld/Bond | 0 |
| Other | 11 |
Product Characteristics
| Lead Type | VDD Single Pass |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LEG, LEE, LEF |
|---|---|
| Lead Body Diameter | 8.1 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | Two IS-1 Bi |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013