4574
CapSure Sense
ALL
Device Survival Probability
| 1 yr | 2 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.5 | ||||||||
| # | 156 | 57 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 490 |
|---|---|
| Cumulative Months of Follow-Up | 5514 |
| Number of Leads Active in Study | 382 |
2
Qualifying Complications
| Lead Dislodgement | 2 |
|---|
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 14 |
| Failure to Sense | 8 |
| Lead Dislodgement | 33 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 61007 |
| Estimated Active USA Implants | 41056 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 274959 |
USA Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 8 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | J-shape, tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | BBE |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013