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 | at 78.0 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.5 | 99.3 | 99.3 | 99.0 | 99.0 | 97.7 | |||
| # | 1715 | 1434 | 1229 | 980 | 782 | 416 | 182 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2113 |
|---|---|
| Cumulative Months of Follow-Up | 91022 |
| Number of Leads Active in Study | 954 |
17
Qualifying Complications
| Conductor Fracture | 9 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 2 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 1 |
| Other | 1 |
US Acute Lead Observations
| Cardiac Perforation | 30 |
|---|---|
| Conductor Fracture | 9 |
| Extra Cardiac Stimulation | 10 |
| Failure to Capture | 94 |
| Failure to Sense | 34 |
| Impedance Out of Range | 26 |
| Lead Dislodgement | 193 |
| Oversensing | 69 |
Distribution Data
| US Market Release | 2012-02-13 |
|---|---|
| CE Approval Date | 2010-03-12 |
| Registered USA Implants | 115553 |
| Estimated Active USA Implants | 103417 |
| US Market Release | 2012-02-13 |
|---|---|
| CE Approval Date | 2010-03-12 |
| Estimated WW Distribution | 228460 |
USA Returned Product Analysis
| Conductor Fracture | 145 |
|---|---|
| Insulation Breach | 13 |
| Crimp/Weld/Bond | 0 |
| Other | 23 |
WW Returned Product Analysis
| Conductor Fracture | 254 |
|---|---|
| Insulation Breach | 19 |
| Crimp/Weld/Bond | 0 |
| Other | 27 |
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 November 8, 2019