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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.4 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 98.6 | |
| # | 951 | 781 | 610 | 447 | 314 | 239 | 198 | 179 | 150 | 102 | 62 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1108 |
|---|---|
| Cumulative Months of Follow-Up | 55235 |
| Number of Leads Active in Study | 431 |
8
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 2 |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | 99.6 | |
| # | 214 | 205 | 198 | 179 | 162 | 154 | 146 | 131 | 118 | 87 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 227 |
|---|---|
| Cumulative Months of Follow-Up | 21793 |
| Number of Leads Active in Study | 114 |
1
Qualifying Complications
| Failure to Sense | 1 |
|---|---|
| Impedance Out of Range | 0 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 19 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 60 |
| Failure to Sense | 1 |
| Impedance Out of Range | 3 |
| Lead Dislodgement | 70 |
| Oversensing | 3 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 110136 |
| Estimated Active USA Implants | 62324 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 728676 |
USA Returned Product Analysis
| Conductor Fracture | 8 |
|---|---|
| Insulation Breach | 34 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 13 |
|---|---|
| Insulation Breach | 37 |
| Crimp/Weld/Bond | 0 |
| Other | 9 |
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 February 3, 2017