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 | 11 yr | 12 yr | 13 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.2 | 98.8 | 98.7 | 98.5 | 97.8 | 97.8 | 97.4 | 97.4 | 97.4 | 97.4 | 97.4 | 97.4 | ||||||||
| # | 2107 | 1377 | 919 | 602 | 402 | 298 | 240 | 191 | 162 | 125 | 106 | 89 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2602 |
|---|---|
| Cumulative Months of Follow-Up | 93014 |
| Number of Leads Active in Study | 1551 |
25
Qualifying Complications
| Failure to Capture | 13 |
|---|---|
| Impedance Out of Range | 2 |
| Lead Dislodgement | 8 |
| Other | 2 |
LEFT BUNDLE PLACEMENT
Device Survival Probability
3830_LBBA_SURV
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| 1 yr | 2 yr | 3 yr | at 42.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.5 | 99.1 | 99.1 | 99.1 | ||||||
| # | 804 | 309 | 122 | 69 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2154 |
|---|---|
| Cumulative Months of Follow-Up | 21713 |
| Number of Leads Active in Study | 1926 |
8
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Impedance Out of Range | 1 |
| Lead Dislodgement | 4 |
HIS BUNDLE PLACEMENT
Device Survival Probability
3830_HIS_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
98.2 | 97.4 | 97.1 | 96.3 | 95.4 | 93.8 | 93.8 | |||
| # | 1215 | 955 | 670 | 418 | 208 | 96 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1506 |
|---|---|
| Cumulative Months of Follow-Up | 51303 |
| Number of Leads Active in Study | 916 |
46
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 33 |
| Failure to Sense | 3 |
| Lead Dislodgement | 5 |
| 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 | 12 yr | 13 yr | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.6 | 99.4 | 99.4 | 99.3 | 99.1 | 98.9 | 98.4 | 97.9 | 97.6 | 96.7 | 96.7 | 96.7 | 96.7 | 96.7 | |||||||
| # | 1488 | 1145 | 933 | 704 | 568 | 456 | 378 | 320 | 272 | 220 | 192 | 156 | 85 | 62 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1841 |
|---|---|
| Cumulative Months of Follow-Up | 93107 |
| Number of Leads Active in Study | 667 |
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 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 86 |
|---|---|
| Conductor Fracture | 5 |
| Extra Cardiac Stimulation | 12 |
| Failure to Capture | 664 |
| Failure to Sense | 103 |
| Impedance Out of Range | 61 |
| Insulation Breach | 2 |
| Lead Dislodgement | 855 |
| Oversensing | 133 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 259709 |
| Estimated Active USA Implants | 225918 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 717732 |
USA Returned Product Analysis
| Conductor Fracture | 41 |
|---|---|
| Insulation Breach | 111 |
| Crimp/Weld/Bond | 0 |
| Other | 23 |
WW Returned Product Analysis
| Conductor Fracture | 50 |
|---|---|
| Insulation Breach | 122 |
| Crimp/Weld/Bond | 0 |
| Other | 26 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Fixed Screw |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium, Ventricle, Bundle of His, or Left Bundle Branch Area |
| 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 November 20, 2024