Alerta De Seguridad O Notificaciones De Seguridad para Pacemakers and CRT-P

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.

Boston Scientific issued an FSN on the 19 December 2017, following reports of pacing inhibition due to oversensing of the MV sensor signal. Note that the nominal setting for MV sensor in affected Boston Scientific pacemakers is “Passive”, which presents the same patient risk of oversensing as when it is reprogrammed to “ON”.There are approximately 32,500 affected patients at 308 centres in the UK. To date there have been 184 reported oversensing events worldwide (22 in the UK) representing 0.05% of sales of these device models. These include 31 known incidents of serious injury or death (8 in the UK) including patient dizziness, syncope or falls. The true prevalence of the MV oversensing is, however, unknown as it can go undetected if the patient remains asymptomatic.Intermittency related to the lead or pacemaker-lead connection can lead to transient high impedance conditions, which can alter the MV sensor signal which can become visible on an electrogram and potentially cause oversensing on the right atrial or right ventricular channels. Further information is provided in the FSN.Based upon data from reported events, and testing of competitors’ leads, Boston Scientific has indicated that the issue tends to be more prevalent in leads with greater terminal ring motion within the pacemaker header such as Medtronic or Abbott leads. Boston Scientific has also indicated that over 60% of MV oversensing reports have involved their devices connected to Medtronic or Abbott leads, despite only around 12% of the affected models being implanted with these competitors leads (based on US data).A software fix mitigating the risk of MV oversensing is currently being developed by the manufacturer and is planned to be released by October 2018. In the meantime, an accelerometer based rate response function can be programmed for these pacemakers where deemed clinically necessary. Further information is available from Boston Scientific.Note that some patients affected by this MV field action may also be affected by a second FSN issued simultaneously by Boston Scientific on left ventricular offset interaction, which provides separate patient management recommendations not covered by this MHRA alert.