4074
CapSure Sense
VENTRICULAR PLACEMENT
Device Survival Probability
4074_VEN_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | at 150.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 99.3 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 98.6 | 98.6 | 98.6 | 98.6 | ||||||||
| # | 1003 | 832 | 688 | 587 | 443 | 309 | 243 | 196 | 166 | 146 | 131 | 79 | 63 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1157 |
|---|---|
| Cumulative Months of Follow-Up | 65561 |
| Number of Leads Active in Study | 326 |
9
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 1 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 2 |
| Other | 1 |
ATRIAL PLACEMENT
Device Survival Probability
4074_ATR_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | 99.1 | ||||||||
| # | 214 | 205 | 198 | 183 | 167 | 158 | 148 | 135 | 125 | 113 | 103 | 76 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 227 |
|---|---|
| Cumulative Months of Follow-Up | 24411 |
| Number of Leads Active in Study | 99 |
2
Qualifying Complications
| Failure to Sense | 1 |
|---|---|
| Lead Dislodgement | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 25 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 93 |
| Failure to Sense | 5 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 121 |
| Oversensing | 6 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 128034 |
| Estimated Active USA Implants | 77325 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 847800 |
USA Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 40 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 16 |
|---|---|
| Insulation Breach | 43 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | BBD |
|---|---|
| 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 April 11, 2019