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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 99.0 | 98.8 | 98.5 | 98.5 | 98.0 | 98.0 | 97.3 | ||
| # | 593 | 489 | 405 | 318 | 251 | 202 | 140 | 66 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 772 |
|---|---|
| Cumulative Months of Follow-Up | 34626 |
| Number of Leads Active in Study | 354 |
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 | at 102.0 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.3 | 99.0 | 99.0 | 98.9 | 98.7 | 98.4 | 97.8 | 97.0 | 96.3 | |
| # | 896 | 739 | 628 | 514 | 418 | 349 | 247 | 122 | 74 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1100 |
|---|---|
| Cumulative Months of Follow-Up | 54197 |
| Number of Leads Active in Study | 483 |
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 |
HIS PLACEMENT
Device Survival Probability
3830_HIS_SURV
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| 1 yr | 2 yr | 3 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
98.0 | 98.0 | 98.0 | |||||||
| # | 133 | 91 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | |
|---|---|
| Cumulative Months of Follow-Up | |
| Number of Leads Active in Study |
Qualifying Complications
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 11 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 4 |
| Failure to Capture | 145 |
| Failure to Sense | 7 |
| Impedance Out of Range | 1 |
| Insulation Breach | 1 |
| Lead Dislodgement | 190 |
| Oversensing | 35 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Registered USA Implants | 49472 |
| Estimated Active USA Implants | 39220 |
| US Market Release | 2005-08-03 |
|---|---|
| CE Approval Date | 2003-01-31 |
| Estimated WW Distribution | 124126 |
USA Returned Product Analysis
| Conductor Fracture | 23 |
|---|---|
| Insulation Breach | 36 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
WW Returned Product Analysis
| Conductor Fracture | 30 |
|---|---|
| Insulation Breach | 41 |
| 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 April 11, 2019