"the patient did not wear a lead support belt in accordance with...

"the patient did not wear a lead support belt in accordance with instructions for use"

what a ridiculous statement! evidently the lead setup was not designed to be fail-safe - i mean they are dealing with very sick and probably quite elderly patients here.
First it was the medico's ignorance that was slowing down uptake - now its the patients' fault that the leads failed!
(but wasn't bowtie involved in the design of the LVAS4? - his name was on the patent if I remember correctly - what a joke!)

These guys have seriously lost the plot

grrrrrrr!!!