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 | at 114.0 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 98.9 | 98.7 | 98.4 | 98.4 | 97.6 | 97.6 | 97.1 | 97.1 | 97.1 |
| # | 777 | 565 | 476 | 353 | 295 | 236 | 188 | 158 | 117 | 83 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1245 |
|---|---|
| Cumulative Months of Follow-Up | 44540 |
| Number of Leads Active in Study | 719 |
14
Qualifying Complications
| Failure to Capture | 7 |
|---|---|
| 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 | at 54.0 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
97.9 | 96.2 | 95.6 | 93.7 | 92.2 | |||||
| # | 488 | 211 | 109 | 73 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1012 |
|---|---|
| Cumulative Months of Follow-Up | 15103 |
| Number of Leads Active in Study | 831 |
25
Qualifying Complications
| Failure to Capture | 19 |
|---|---|
| Failure to Sense | 1 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 2 |
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.4 | 99.2 | 99.2 | 99.0 | 98.8 | 98.6 | 98.1 | 97.4 | 97.1 | 95.7 | 95.7 | ||||||||||
| # | 991 | 796 | 684 | 544 | 460 | 391 | 328 | 285 | 211 | 100 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1346 |
|---|---|
| Cumulative Months of Follow-Up | 65274 |
| Number of Leads Active in Study | 608 |
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 | 32 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 8 |
| Failure to Capture | 309 |
| Failure to Sense | 28 |
| Impedance Out of Range | 8 |
| Insulation Breach | 1 |
| Lead Dislodgement | 360 |
| Oversensing | 75 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 95696 |
| Estimated Active USA Implants | 73404 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 287110 |
USA Returned Product Analysis
| Conductor Fracture | 29 |
|---|---|
| Insulation Breach | 52 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 36 |
|---|---|
| Insulation Breach | 57 |
| 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 October 11, 2021