3830
SelectSecure
VENTRICULAR PLACEMENT
Device Survival Probability
3830_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 | at 126.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 98.9 | 98.5 | 98.3 | 98.3 | 97.5 | 97.5 | 97.0 | 97.0 | 97.0 | 97.0 | ||||||||||
| # | 920 | 623 | 496 | 368 | 300 | 245 | 205 | 162 | 132 | 85 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1454 |
|---|---|
| Cumulative Months of Follow-Up | 49094 |
| Number of Leads Active in Study | 877 |
16
Qualifying Complications
| Failure to Capture | 9 |
|---|---|
| Impedance Out of Range | 1 |
| Lead Dislodgement | 5 |
| Other | 1 |
HIS BUNDLE PLACEMENT
Device Survival Probability
3830_HIS_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
97.9 | 96.5 | 96.1 | 94.5 | 91.6 | |||||
| # | 671 | 300 | 139 | 84 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1143 |
|---|---|
| Cumulative Months of Follow-Up | 20012 |
| Number of Leads Active in Study | 903 |
31
Qualifying Complications
| Failure to Capture | 23 |
|---|---|
| Failure to Sense | 2 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 2 |
| Oversensing | 1 |
| Other | 3 |
ATRIAL PLACEMENT
Device Survival Probability
3830_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 | at 138.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.5 | 99.2 | 99.2 | 99.1 | 98.9 | 98.7 | 98.1 | 97.5 | 97.2 | 96.2 | 96.2 | 96.2 | |||||||||
| # | 1070 | 847 | 703 | 566 | 463 | 398 | 338 | 287 | 237 | 160 | 71 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1418 |
|---|---|
| Cumulative Months of Follow-Up | 69373 |
| Number of Leads Active in Study | 640 |
19
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 4 |
| Failure to Sense | 3 |
| Impedance Out of Range | 2 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 4 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 34 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 8 |
| Failure to Capture | 317 |
| Failure to Sense | 28 |
| Impedance Out of Range | 8 |
| Insulation Breach | 1 |
| Lead Dislodgement | 368 |
| Oversensing | 78 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 99929 |
| Estimated Active USA Implants | 77293 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 302158 |
USA Returned Product Analysis
| Conductor Fracture | 29 |
|---|---|
| Insulation Breach | 53 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 36 |
|---|---|
| Insulation Breach | 59 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Fixed Screw |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium or Right Ventricle or Bundle of His |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LFF |
|---|---|
| Lead Body Diameter | 4.1 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of December 16, 2021