This advisory is limited to devices identified in the
product model list that were implanted subpectorally. Devices implanted
subcutaneously are not included in this advisory.
Boston Scientific has determined that the bond between the
header and case could be weakened by significant forces associated with a
subpectoral implant procedure or when a device in a subpectoral position is
pushed against a rib during contraction of the pectoralis muscle. A weakened
header bond may alter lead impedance and introduce noise that may inhibit
pacing therapy or initiate inappropriate tachy therapy. Additional mechanical
stress applied to a weakened bond may eventually cause header connection wires
to fracture, resulting in loss of therapy.
