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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 98.7 | 98.3 | 98.1 | 97.8 | 97.1 | 97.1 | 96.7 | 96.7 | 96.7 | 96.7 | 96.7 | |||||||||
| # | 1334 | 905 | 616 | 420 | 334 | 262 | 219 | 182 | 146 | 116 | 87 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2393 |
|---|---|
| Cumulative Months of Follow-Up | 65296 |
| Number of Leads Active in Study | 1651 |
25
Qualifying Complications
| Failure to Capture | 14 |
|---|---|
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
97.8 | 96.9 | 96.2 | 95.2 | 92.1 | 90.6 | ||||
| # | 1008 | 659 | 355 | 168 | 91 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1387 |
|---|---|
| Cumulative Months of Follow-Up | 34621 |
| Number of Leads Active in Study | 985 |
46
Qualifying Complications
| Failure to Capture | 35 |
|---|---|
| Failure to Sense | 3 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 4 |
| Oversensing | 1 |
| Other | 2 |
| Unspecified Clinical Failure | 1 |
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 | at 150.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.5 | 99.3 | 99.3 | 99.1 | 99.0 | 98.7 | 98.2 | 97.6 | 97.3 | 96.4 | 96.4 | 96.4 | 96.4 | ||||||||
| # | 1241 | 986 | 798 | 619 | 503 | 416 | 354 | 307 | 255 | 212 | 161 | 93 | 60 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1679 |
|---|---|
| Cumulative Months of Follow-Up | 80081 |
| Number of Leads Active in Study | 775 |
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 | 50 |
|---|---|
| Conductor Fracture | 5 |
| Extra Cardiac Stimulation | 9 |
| Failure to Capture | 455 |
| Failure to Sense | 54 |
| Impedance Out of Range | 26 |
| Insulation Breach | 2 |
| Lead Dislodgement | 543 |
| Oversensing | 93 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 153960 |
| Estimated Active USA Implants | 127406 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 455053 |
USA Returned Product Analysis
| Conductor Fracture | 35 |
|---|---|
| Insulation Breach | 72 |
| Crimp/Weld/Bond | 0 |
| Other | 13 |
WW Returned Product Analysis
| Conductor Fracture | 43 |
|---|---|
| Insulation Breach | 82 |
| Crimp/Weld/Bond | 0 |
| Other | 15 |
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 May 10, 2023