Upon receipt at our post market quality assurance laboratory, this lead was confirmed to be fractured.Based on the analysis results, we suspect that fatigue or stress in the region of the fracture site due to relative motion between the suture sleeve and an anatomical feature led to the fracture.As a lead moves in response to normal heart rhythms and blood flow, extensive flexing over a period of time may cause fatigue or stress, weakening the coil, ultimately resulting in a fracture.This can occur between the suture sleeve and some other part of the anatomy.Fatigue fractures in the pocket or clavicular/first rib area are well known and documented in the industry.A combination of lead design, implant techniques, and patient anatomy and activity level contribute to these types of occurrences.Updated evaluation results code and evaluation conclusion code.
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