5038
CapSure VDD-2
ALL
Device Survival Probability
5038_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.3 | 99.3 | 97.9 | 97.1 | 97.1 | 94.1 | |||
| # | 288 | 218 | 160 | 132 | 105 | 78 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 570 |
|---|---|
| Cumulative Months of Follow-Up | 15946 |
| Number of Leads Active in Study | 3 |
8
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Failure to Capture | 2 |
| Failure to Sense | 3 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 2 |
| Lead Dislodgement | 7 |
| Oversensing | 2 |
Distribution Data
| US Market Release | 1998-09-10 |
|---|---|
| CE Approval Date | 1997-04-15 |
| Registered USA Implants | 9657 |
| Estimated Active USA Implants | 2205 |
| US Market Release | 1998-09-10 |
|---|---|
| CE Approval Date | 1997-04-15 |
| Estimated WW Distribution | 183694 |
USA Returned Product Analysis
| Conductor Fracture | 8 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 20 |
|---|---|
| Insulation Breach | 15 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
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 | 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 November 20, 2024