6946M
Sprint Quattro
ALL
Device Survival Probability
6946M_SURV
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| at 6.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 57 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 62 |
|---|---|
| Cumulative Months of Follow-Up | 2286 |
| Number of Leads Active in Study | 35 |
1
Qualifying Complications
| Conductor Fracture | 1 |
|---|
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 6 |
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 9 |
| Oversensing | 6 |
Distribution Data
| US Market Release | 2016-01-05 |
|---|---|
| CE Approval Date | 2013-09-12 |
| Registered USA Implants | 4556 |
| Estimated Active USA Implants | 3959 |
| US Market Release | 2016-01-05 |
|---|---|
| CE Approval Date | 2013-09-12 |
| Estimated WW Distribution | 11793 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar/Two Coils |
| Serial Number Prefix | TDN |
|---|---|
| Lead Body Diameter | 2.8 mm |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | DF4-LLHH |
| High Voltage Connector | DF4-LLHH |
| Steroid | Yes |
Data as of November 20, 2024