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 | at 150.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.1 | 98.8 | 98.6 | 98.4 | 97.8 | 97.8 | 97.3 | 97.3 | 97.3 | 97.3 | 97.3 | 97.3 | ||||||||
| # | 1829 | 1156 | 813 | 501 | 369 | 286 | 230 | 187 | 159 | 121 | 106 | 87 | 68 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2575 |
|---|---|
| Cumulative Months of Follow-Up | 82642 |
| Number of Leads Active in Study | 1626 |
23
Qualifying Complications
| Failure to Capture | 12 |
|---|---|
| Impedance Out of Range | 2 |
| Lead Dislodgement | 8 |
| 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 | 6 yr | at 78.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
98.2 | 97.3 | 97.0 | 96.0 | 94.8 | 93.7 | 93.7 | |||
| # | 1158 | 884 | 576 | 308 | 143 | 79 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1490 |
|---|---|
| Cumulative Months of Follow-Up | 45837 |
| Number of Leads Active in Study | 957 |
44
Qualifying Complications
| Failure to Capture | 33 |
|---|---|
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 5 |
| Oversensing | 1 |
| Other | 2 |
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 | 99.3 | 99.3 | 99.2 | 99.1 | 98.9 | 98.4 | 97.8 | 97.5 | 96.7 | 96.7 | 96.7 | 96.7 | 96.7 | |||||||
| # | 1394 | 1083 | 887 | 678 | 536 | 444 | 366 | 315 | 268 | 219 | 192 | 152 | 77 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1827 |
|---|---|
| Cumulative Months of Follow-Up | 88926 |
| Number of Leads Active in Study | 703 |
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 | 73 |
|---|---|
| Conductor Fracture | 5 |
| Extra Cardiac Stimulation | 11 |
| Failure to Capture | 578 |
| Failure to Sense | 88 |
| Impedance Out of Range | 47 |
| Insulation Breach | 2 |
| Lead Dislodgement | 722 |
| Oversensing | 120 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 213132 |
| Estimated Active USA Implants | 182541 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 600655 |
USA Returned Product Analysis
| Conductor Fracture | 39 |
|---|---|
| Insulation Breach | 90 |
| Crimp/Weld/Bond | 0 |
| Other | 14 |
WW Returned Product Analysis
| Conductor Fracture | 48 |
|---|---|
| Insulation Breach | 100 |
| Crimp/Weld/Bond | 0 |
| Other | 16 |
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 April 30, 2024