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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.4 | 99.3 | 99.3 | 99.3 | 99.3 | 99.3 | 99.3 | 99.3 | 98.7 | 98.7 | 98.7 | |||||||||
| # | 982 | 815 | 676 | 548 | 376 | 274 | 210 | 182 | 159 | 132 | 83 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1124 |
|---|---|
| Cumulative Months of Follow-Up | 60823 |
| Number of Leads Active in Study | 378 |
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 | 12 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 | |||||||||
| # | 214 | 205 | 198 | 183 | 167 | 158 | 148 | 134 | 122 | 112 | 74 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 227 |
|---|---|
| Cumulative Months of Follow-Up | 23130 |
| Number of Leads Active in Study | 104 |
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 | 21 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 73 |
| Failure to Sense | 3 |
| Impedance Out of Range | 4 |
| Lead Dislodgement | 91 |
| Oversensing | 4 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 119708 |
| Estimated Active USA Implants | 70043 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 792742 |
USA Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 35 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 15 |
|---|---|
| Insulation Breach | 38 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
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 January 31, 2018