6935M
Sprint Quattro Secure S
ALL
Device Survival Probability
6935M_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 | at 126.0 mo | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.6 | 99.5 | 99.2 | 99.0 | 98.6 | 98.2 | 97.8 | 97.4 | 97.0 | 96.3 | 95.6 | |||||||||||
# | 7654 | 5730 | 4571 | 3762 | 3092 | 2475 | 1865 | 1116 | 563 | 234 | 115 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 10085 |
---|---|
Cumulative Months of Follow-Up | 424941 |
Number of Leads Active in Study | 4231 |
US Acute Lead Observations
Cardiac Perforation | 210 |
---|---|
Conductor Fracture | 22 |
Extra Cardiac Stimulation | 34 |
Failure to Capture | 496 |
Failure to Sense | 177 |
Impedance Out of Range | 147 |
Insulation Breach | 3 |
Lead Dislodgement | 694 |
Oversensing | 378 |
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 | TDL |
---|---|
Lead Body Diameter | 2.8 mm (8.4 Fr) |
Insulation | Silicone with Polyurethane Overlay |
Pace/Sense Connector Style | DF4-LLHO |
High Voltage Connector | DF4-LLHO |
Steroid | Yes |
Data as of November 20, 2024