Single event upsets (SEU) have been observed in implantable cardiac defibri
llators. The incidence of SEUs is well modeled by upset rate calculations a
ttributable to the secondary cosmic ray neutron flux. The effect of recent
interpretations of the shape of the heavy ion cross-section curve on neutro
n burst generation rate calculations is discussed. The model correlates wel
l with clinical experience and is consistent with the expected geographical
variation of the secondary cosmic ray neutron flux. The observed SER was 9
.3 x 10(-12) upsets/bit-hr from 22 upsets collected over a total of 284672
device days. This is the first clinical data set obtained indicating the ef
fects of cosmic radiation on implantable devices. Importantly, it may be us
ed to predict the susceptibility of future implantable device designs to co
smic radiation. The significance of cosmic radiation effects relative to ot
her radiation sources applicable to implantable devices is discussed.