Patrick E. O'Brien and Nancy O'Brien v‪.‬

Patrick and Nancy O'Brien appeal a judgment and order dismissing their complaint against Medtronic, Inc. The O'Briens contend
that the trial court erred by concluding that they could not recover damages incurred when Patrick had a Medtronic pacemaker
lead implanted in his chest replaced even though his lead appeared to be operating properly. The trial court found there was
no evidence that his original unit was defective, that it had not at any time malfunctioned, and that replacement was not
medically necessary. We conclude as a matter of law that the O'Briens cannot recover because the alleged wrongful acts on
the part of Medtronic are too remote from their injuries. Therefore, we affirm. In January, 1982, Patrick had a Medtronic pacemaker and polyurethane insulated lead, Model 6972, implanted. On February 20,
1984, Medtronic issued a memo stating that the failure rate for Model 6972 leads at that time was five in one thousand per
month three years after implant, or approximately ten percent after three years. On June 25, Medtronic notified doctors that
a previously issued FDA Class II recall was being upgraded to a Class I recall for unused units based on concern for "the
very small number of totally pacemaker dependent patients." 1