5568
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 | 99.2 | 99.2 | 99.2 | 98.8 | 97.8 | 97.8 | 97.8 | 97.8 | 97.8 | 97.8 | ||||||||||
| # | 712 | 526 | 402 | 287 | 222 | 170 | 136 | 114 | 95 | 72 | 45 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1053 |
|---|---|
| Cumulative Months of Follow-Up | 40661 |
| Number of Leads Active in Study | 99 |
11
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 5 |
| Failure to Sense | 2 |
| Lead Dislodgement | 1 |
| Oversensing | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 7 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 19 |
| Failure to Sense | 2 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 30 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 1997-01-02 |
|---|---|
| CE Approval Date | 1996-08-14 |
| Registered USA Implants | 90933 |
| Estimated Active USA Implants | 50511 |
| US Market Release | 1997-01-02 |
|---|---|
| CE Approval Date | 1996-08-14 |
| Estimated WW Distribution | 143883 |
USA Returned Product Analysis
| Conductor Fracture | 13 |
|---|---|
| Insulation Breach | 28 |
| Crimp/Weld/Bond | 0 |
| Other | 38 |
WW Returned Product Analysis
| Conductor Fracture | 14 |
|---|---|
| Insulation Breach | 29 |
| Crimp/Weld/Bond | 0 |
| Other | 96 |
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 | LDN |
|---|---|
| Lead Body Diameter | 7.2 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013