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 | 13 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 99.3 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 99.2 | 98.6 | 98.6 | 97.8 | 97.8 | ||||||||
| # | 1009 | 840 | 697 | 590 | 458 | 334 | 254 | 207 | 168 | 146 | 137 | 108 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1168 |
|---|---|
| Cumulative Months of Follow-Up | 67456 |
| Number of Leads Active in Study | 314 |
10
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 2 |
| 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 | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
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 | 99.1 | |||||||
| # | 214 | 205 | 198 | 183 | 167 | 158 | 148 | 135 | 126 | 114 | 106 | 93 | 61 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 227 |
|---|---|
| Cumulative Months of Follow-Up | 24976 |
| Number of Leads Active in Study | 98 |
2
Qualifying Complications
| Failure to Capture | 0 |
|---|---|
| Failure to Sense | 1 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 1 |
| Other | 0 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 26 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 104 |
| Failure to Sense | 6 |
| Impedance Out of Range | 3 |
| Lead Dislodgement | 140 |
| Oversensing | 7 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 132863 |
| Estimated Active USA Implants | 80244 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 881190 |
USA Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 41 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 16 |
|---|---|
| Insulation Breach | 44 |
| 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 November 8, 2019