5032
CapSure VDD
ALL
Device Survival Probability
| at 0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 37 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 38 |
|---|---|
| Cumulative Months of Follow-Up | 1683 |
| Number of Leads Active in Study | 0 |
1
Qualifying Complications
| Failure to Sense | 1 |
|---|
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Failure to Capture | 1 |
|---|---|
| Failure to Sense | 1 |
| Lead Dislodgement | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1996-03-22 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 5307 |
| Estimated Active USA Implants | 1209 |
| US Market Release | 1996-03-22 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 9005 |
USA Returned Product Analysis
| Conductor Fracture | 7 |
|---|---|
| Insulation Breach | 6 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 8 |
| Crimp/Weld/Bond | 1 |
| Other | 0 |
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 | Quadripolar |
| Serial Number Prefix | LCN, LCM, LCL |
|---|---|
| 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