6949
Sprint Fidelis
ALL

Device Survival Probability
6949_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 | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
% | ![]() |
98.5 | 96.5 | 93.4 | 91.0 | 88.2 | 84.4 | 81.5 | 79.3 | 78.6 | 77.2 | 71.5 | 69.0 | 66.6 | ||||||||
# | 717 | 624 | 530 | 456 | 390 | 342 | 280 | 236 | 188 | 153 | 126 | 94 | 65 |
Product Surveillance Registry Results
Number of Leads Enrolled in Study | 980 |
---|---|
Cumulative Months of Follow-Up | 55832 |
Number of Leads Active in Study | 73 |

US Acute Lead Observations
Cardiac Perforation | 10 |
---|---|
Conductor Fracture | 48 |
Failure to Capture | 32 |
Failure to Sense | 19 |
Impedance Out of Range | 19 |
Insulation Breach | 5 |
Lead Dislodgement | 22 |
Oversensing | 35 |
Unspecified Clinical Failure | 25 |

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 | LFJ |
---|---|
Lead Body Diameter | 6.6 FR |
Insulation | Silicone with Polyurethane Overlay |
Pace/Sense Connector Style | IS-1 BI |
High Voltage Connector | DF-1 |
Steroid | Yes |
Data as of October 29, 2020