The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).
Model 4196 LV lead complication-free survivability will be summarized.
Study Type
OBSERVATIONAL
Enrollment
1,847
Lead-related complication rate
Time frame: 5 years
Types of lead-related events
Time frame: 5 years
Percent of subjects with changes in electrode programming
Time frame: 5 Years
Percent of fractures with loss of function
Time frame: 5 years
Mean bipolar pacing threshold
Time frame: 1 year
Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Gilbert, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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East Palo Alto, California, United States
...and 93 more locations