6947M
Sprint Quattro Secure
ALL
Device Survival Probability
6947M_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.5 | 99.3 | 99.3 | 99.0 | 99.0 | 98.3 | |||
| # | 1737 | 1453 | 1258 | 1007 | 823 | 584 | 162 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2136 |
|---|---|
| Cumulative Months of Follow-Up | 96581 |
| Number of Leads Active in Study | 906 |
17
Qualifying Complications
| Conductor Fracture | 9 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 2 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 1 |
| Other | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 32 |
|---|---|
| Conductor Fracture | 9 |
| Extra Cardiac Stimulation | 10 |
| Failure to Capture | 96 |
| Failure to Sense | 36 |
| Impedance Out of Range | 26 |
| Lead Dislodgement | 201 |
| Oversensing | 72 |
Distribution Data
| US Market Release | 2012-02-13 |
|---|---|
| CE Approval Date | 2010-03-12 |
| Registered USA Implants | 118538 |
| Estimated Active USA Implants | 104466 |
| US Market Release | 2012-02-13 |
|---|---|
| CE Approval Date | 2010-03-12 |
| Estimated WW Distribution | 234527 |
USA Returned Product Analysis
| Conductor Fracture | 160 |
|---|---|
| Insulation Breach | 12 |
| Crimp/Weld/Bond | 0 |
| Other | 27 |
WW Returned Product Analysis
| Conductor Fracture | 271 |
|---|---|
| Insulation Breach | 18 |
| Crimp/Weld/Bond | 0 |
| Other | 31 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Active Screw In |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar/Two Coils |
| Serial Number Prefix | TDK |
|---|---|
| Lead Body Diameter | 8.6 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | DF4-LLHH |
| High Voltage Connector | DF4-LLHH |
| Steroid | Yes |
Data as of April 10, 2020