6947
Sprint Quattro Secure
ALL
Device Survival Probability
6947_SURV
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1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | 15 yr | 16 yr | 17 yr | 18 yr | 19 yr | at 234.0 mo | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.5 | 99.3 | 99.0 | 98.7 | 98.2 | 97.9 | 97.5 | 97.1 | 96.7 | 96.1 | 95.8 | 95.5 | 95.0 | 94.5 | 94.1 | 92.0 | 92.0 | 90.5 | 88.4 | 87.1 | ||
# | 3302 | 2902 | 2548 | 2259 | 2025 | 1787 | 1541 | 1380 | 1233 | 1073 | 885 | 679 | 514 | 332 | 204 | 146 | 120 | 100 | 78 | 58 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 4583 |
---|---|
Cumulative Months of Follow-Up | 298935 |
Number of Leads Active in Study | 570 |
US Acute Lead Observations
Cardiac Perforation | 29 |
---|---|
Conductor Fracture | 26 |
Extra Cardiac Stimulation | 2 |
Failure to Capture | 83 |
Failure to Sense | 36 |
Impedance Out of Range | 61 |
Insulation Breach | 4 |
Lead Dislodgement | 124 |
Oversensing | 141 |
Unspecified Clinical Failure | 20 |
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 | TDG |
---|---|
Lead Body Diameter | 8.6 FR |
Insulation | Silicone with Polyurethane Overlay |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | DF-1 |
Steroid | Yes |
Data as of April 30, 2024