External pacemaker 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Risk of under-sensing or output failure when used on patients with epicardial pacing wires.In April 2012, Pace Medical issued a Field Safety Notice (314Kb) (FSN) due to a risk of inadequate output from these pacemakers, which they now understand to arise from damage caused by application of direct heart defibrillation when the pacemaker is used with epicardial pacing wires.  The manufacturer then began action aimed at solving the output problem by replacing an electronic component in devices in the field.At the end of June 2012, the manufacturer issued a second FSN (393Kb) due to reports of under-sensing, once again when the pacemaker was used with epicardial pacing wires following surgery.A further schedule of field up-grades began for all 4,580 pacemakers in use.In September 2012, the manufacturer issued a third FSN (372Kb) to implement a further hardware upgrade to these temporary pacemakers, introducing a component to provide greater protection in the event of defibrillation.  This action arose from their continued investigations, which had improved their understanding of the root cause of the failures.To date there have been no reported problems when these pacemakers have been used with temporary endocardial pacing leads.