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Reduced Ion Permeability
When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.
PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula