Implantable cardiac pacemakers 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.

Medtronic issued a Field Safety Notice on 17 January 2019 addressing the potential risk of loss of pacing therapy in a specific subset of dual chamber pacemakers. The problem is limited to these pacemakers when programmed to a dual chamber mode with atrial-sensing.156,957 potentially affected devices were distributed worldwide from March 2017 to January 2019 inclusive, with around 7,400 sold in the UK. Devices distributed before March 2017 are not affected.These pacemakers are at risk of experiencing a circuit error following an atrial sensed event, that may result in a device lock-up condition. During the lock-up condition, the pacemaker will not provide atrial or ventricular pacing, neither will it initiate a session with the programmer or CareLink remote monitor or respond to a magnet.For most patients the chance of device circuit error is low, estimated by Medtronic to be around 2.8% per month. This, however, increases significantly for patients in atrial fibrillation, whose pacemaker is atrial sensing, due to the high number of atrial sensed events.The pacemaker will resume normal pacing therapy as soon as an intrinsic ventricular event is detected. Therefore, patients with no ventricular escape rhythm are at greatest risk, as the cessation of pacing will be prolonged. Attention should also be paid to patients previously suspected to have experienced ventricular over-sensing, especially if this resulted in programming changes to ventricular sensing threshold.As of the date of the FSN, there had been 4 non-UK events of clinically apparent pause in 2 patients ranging from 6 to 61 seconds. However, according to the analysis performed by Medtronic using CareLink data, for most patients the duration of the pacing pause would be clinically insignificant in the event of a circuit error, due to the detection of a ventricular sensed event.A software fix mitigating the risk of circuit error is currently being developed by the manufacturer and is estimated to be released in the second half of 2019.
Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing.