6935
Sprint Quattro Secure S
ALL
Device Survival Probability
6935_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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.5 | 99.3 | 98.9 | 98.6 | 98.5 | 98.1 | 97.5 | 96.8 | 95.9 | 94.7 | 94.3 | 93.9 | 93.3 | |||||||||
# | 2415 | 1976 | 1626 | 1330 | 1125 | 968 | 807 | 678 | 571 | 432 | 248 | 143 | 57 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 2977 |
---|---|
Cumulative Months of Follow-Up | 164563 |
Number of Leads Active in Study | 720 |
US Acute Lead Observations
Cardiac Perforation | 29 |
---|---|
Conductor Fracture | 3 |
Extra Cardiac Stimulation | 2 |
Failure to Capture | 35 |
Failure to Sense | 15 |
Impedance Out of Range | 28 |
Insulation Breach | 1 |
Lead Dislodgement | 68 |
Oversensing | 67 |
Unspecified Clinical Failure | 5 |
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/One Coil |
Serial Number Prefix | TAU |
---|---|
Lead Body Diameter | 8,2 FR |
Insulation | Silicone with Polyurethane Overlay |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | DF-1 |
Steroid | Yes |
Data as of December 1, 2023