6940
CapSureFix
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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.6 | 98.3 | 98.1 | 98.1 | 98.1 | 98.1 | 98.1 | 98.1 | 98.1 | 94.8 | ||||||||||
| # | 641 | 530 | 441 | 364 | 306 | 254 | 205 | 157 | 125 | 95 | 51 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 816 |
|---|---|
| Cumulative Months of Follow-Up | 43939 |
| Number of Leads Active in Study | 80 |
12
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Sense | 3 |
| Lead Dislodgement | 3 |
| Oversensing | 5 |
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 | 1 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 6 |
Distribution Data
| US Market Release | 1998-10-09 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 25367 |
| Estimated Active USA Implants | 7210 |
| US Market Release | 1998-10-09 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 31731 |
USA Returned Product Analysis
| Conductor Fracture | 12 |
|---|---|
| Insulation Breach | 17 |
| Crimp/Weld/Bond | 0 |
| Other | 15 |
WW Returned Product Analysis
| Conductor Fracture | 16 |
|---|---|
| Insulation Breach | 31 |
| Crimp/Weld/Bond | 0 |
| Other | 39 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Active Screw-in |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | TCP |
|---|---|
| Lead Body Diameter | 7.2 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Ster |
Data as of March 12, 2013