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 | 8 yr | 9 yr | 10 yr | at 126.0 mo | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 99.7 | 99.5 | 99.4 | 99.4 | 99.0 | 98.9 | 98.1 | 97.8 | 97.3 | 97.1 | 97.1 | |||||||||||
# | 1834 | 1547 | 1363 | 1157 | 1002 | 838 | 697 | 575 | 453 | 222 | 94 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 2378 |
---|---|
Cumulative Months of Follow-Up | 128937 |
Number of Leads Active in Study | 693 |
US Acute Lead Observations
Cardiac Perforation | 40 |
---|---|
Conductor Fracture | 15 |
Extra Cardiac Stimulation | 12 |
Failure to Capture | 117 |
Failure to Sense | 46 |
Impedance Out of Range | 37 |
Insulation Breach | 1 |
Lead Dislodgement | 238 |
Oversensing | 85 |
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 December 1, 2023