Events

Safety Alert Or Field Safety Notices for Pacemakers and CRT-P

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Boston Scientific.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2018/001
  • Date
    2018-01-12
  • Event Date Posted
    2018-01-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/pacemakers-and-crt-p-oversensing-of-minute-ventilation-sensor-signal-leading-to-risk-of-syncope-and-pre-syncope
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Manufactured by boston scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal (mda/2018/001).
  • Action
    Read the manufacturer’s Field Safety Notice (FSN) Identify all patients implanted with the affected devices listed below. Schedule a follow-up of pacemaker-dependent patients as soon as possible, within 6 weeks, with priority to those with pacemakers connected to competitors’ pacing leads (see Problem/background). This should include reassessment of patients whose current degree of pacemaker-dependency is uncertain. Turn off the minute ventilation (MV) sensor for all pacemaker-dependent patients. Evaluate the risks of pacing inhibition against the benefits of MV based rate adaptive pacing (and other MV based diagnostic functions) within 6 months for patients not considered to be pacemaker-dependent. Prioritise those with pacemakers connected to competitors’ pacing leads (see Problem/background). Consider the following for patients left with the MV sensor “ON”: * monitoring for signs of MV oversensing, such as transient, abrupt changes or out-of-range RA/RV pacing impedance measurements, or MV sensor signal artefacts on ECGs. * increasing the frequency of patient follow-ups to assess for future pacemaker dependency. Adopt increased vigilance and report any suspected incidents to the MHRA and Boston Scientific

Device

Pacemakers and CRT-P
  • Model / Serial
  • Product Description
    Product name Models VALITUDE™ CRT-P U125, U128 ACCOLADE™ Pacemakers L300, L301, L310, L311, L321, L331 ESSENTIO™ Pacemakers L100, L101, L110, L111, L121, L131 VISIONIST™ CRT-P U225, U226, U228 PROPONENT™ Pacemakers L200, L201, L209, L210, L211, L221, L231 ALTRUA™ 2 Pacemakers S701, S702, S722In addition to the FSN which details affected product, please refer to the Excel spreadsheet below which accompanies this MDA for additional unique device identification information.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHRA