4798
Attain Stability
ALL
Device Survival Probability
4798_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.9 | 99.6 | 99.6 | 99.6 | ||||||
| # | 463 | 221 | 116 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 985 |
|---|---|
| Cumulative Months of Follow-Up | 14520 |
| Number of Leads Active in Study | 757 |
3
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 0 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 1 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 6 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 73 |
| Failure to Capture | 68 |
| Impedance Out of Range | 27 |
| Lead Dislodgement | 86 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 2017-04-17 |
|---|---|
| CE Approval Date | 2020-05-01 |
| Registered USA Implants | 37187 |
| Estimated Active USA Implants | 34936 |
| US Market Release | 2017-04-17 |
|---|---|
| CE Approval Date | 2020-05-01 |
| Estimated WW Distribution | 100397 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 9 |
WW Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 14 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Non-electrically Active Side Fixation |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Quadripolar |
| Serial Number Prefix | QFX |
|---|---|
| Lead Body Diameter | 4.4 FR |
| Insulation | Polyurethane (outer) SI-polyimide (SI-PI)(inner) |
| Pace/Sense Connector Style | IS4-LLLL |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of May 10, 2023