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 | at 102.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 99.0 | 98.8 | 98.6 | 98.6 | 98.1 | 98.1 | 97.5 | 97.5 | |
| # | 622 | 519 | 413 | 327 | 272 | 207 | 162 | 92 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 888 |
|---|---|
| Cumulative Months of Follow-Up | 36818 |
| Number of Leads Active in Study | 454 |
10
Qualifying Complications
| Failure to Capture | 4 |
|---|---|
| Impedance Out of Range | 1 |
| Lead Dislodgement | 4 |
| Other | 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.3 | 99.1 | 99.1 | 98.9 | 98.7 | 98.5 | 97.9 | 97.2 | 96.7 | |
| # | 928 | 774 | 634 | 520 | 435 | 352 | 284 | 179 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1163 |
|---|---|
| Cumulative Months of Follow-Up | 57220 |
| Number of Leads Active in Study | 517 |
18
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| 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 |
HIS PLACEMENT
Device Survival Probability
3830_HIS_SURV
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| 1 yr | 2 yr | 3 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
98.2 | 97.6 | 97.6 | |||||||
| # | 178 | 108 | 68 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 537 |
|---|---|
| Cumulative Months of Follow-Up | 6799 |
| Number of Leads Active in Study | 464 |
8
Qualifying Complications
| Failure to Capture | 6 |
|---|---|
| Impedance Out of Range | 0 |
| Lead Dislodgement | 1 |
| Oversensing | 1 |
| Other | 0 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 15 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 5 |
| Failure to Capture | 187 |
| Failure to Sense | 10 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 218 |
| Oversensing | 47 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 58098 |
| Estimated Active USA Implants | 46768 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 154726 |
USA Returned Product Analysis
| Conductor Fracture | 24 |
|---|---|
| Insulation Breach | 41 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 31 |
|---|---|
| Insulation Breach | 46 |
| Crimp/Weld/Bond | 0 |
| Other | 9 |
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 |
| 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 8, 2019