3830
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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 | 98.7 | 98.5 | 98.3 | 98.3 | 97.5 | 97.5 | 96.9 | 96.9 | 96.9 |
| # | 684 | 548 | 461 | 346 | 288 | 231 | 183 | 151 | 98 | 69 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1118 |
|---|---|
| Cumulative Months of Follow-Up | 41812 |
| Number of Leads Active in Study | 607 |
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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
98.2 | 96.6 | 96.6 | 94.4 | ||||||
| # | 366 | 169 | 98 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 841 |
|---|---|
| Cumulative Months of Follow-Up | 12014 |
| Number of Leads Active in Study | 695 |
18
Qualifying Complications
| Failure to Capture | 14 |
|---|---|
| Failure to Sense | 1 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 2 |
| Oversensing | 1 |
| Other | 0 |
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 | at 126.0 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.4 | 99.2 | 99.2 | 99.0 | 98.8 | 98.6 | 98.0 | 97.4 | 97.0 | 95.2 | |
| # | 961 | 781 | 673 | 540 | 458 | 386 | 324 | 279 | 178 | 74 | 59 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1266 |
|---|---|
| Cumulative Months of Follow-Up | 63202 |
| Number of Leads Active in Study | 551 |
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 | 26 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 6 |
| Failure to Capture | 247 |
| Failure to Sense | 20 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 288 |
| Oversensing | 56 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 73220 |
| Estimated Active USA Implants | 59861 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 205772 |
USA Returned Product Analysis
| Conductor Fracture | 27 |
|---|---|
| Insulation Breach | 45 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 34 |
|---|---|
| Insulation Breach | 50 |
| 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 29, 2020