Events

Safety Alert Or Field Safety Notices for Implantable cardiac pacemakers

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 Medtronic Inc.

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/2019/008
  • Date
    2019-02-13
  • Event Date Posted
    2019-02-13
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/implantable-cardiac-pacemakers-specific-brands-of-dual-chamber-pacemakers-risk-of-syncope-due-to-pause-in-pacing-therapy
  • 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
    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.
  • Reason
    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 (mda/2019/008).
  • Action
    Read the manufacturer's Field Safety Notice (FSN) Identify all affected devices supplied to your hospital between March 2017 and January 2019 using the serial number look-up tool on Medtronic’s Product Performance website Additional support in identifying affected devices is available from Medtronic - see details in 'Manufacturer contact Do not implant affected devices; quarantine them and contact Medtronic to arrange return. Identify all patients already implanted with an affected device and verify the programmed pacing mode for their pacemaker. Arrange an in-clinic assessment for all patients with a pacemaker programmed to a susceptible pacing mode see FSN. Prioritise patients without an underlying escape rhythm to prevent syncope who should be seen as soon as possible and ideally within 1 month. Be aware that if these patients are also in atrial fibrillation, this increases the risk of a circuit error occurring. Follow the recommendations for pacemaker reprogramming included in the FSN. Consider pacemaker replacement for patients without an underlying ventricular escape rhythm who are unable to tolerate a non-susceptible pacing mode, taking account of their individual procedure-related risk.Report adverse events involving these devices either directly or through your local incident reporting system to your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to the manufacturer.Action byAll cardiologists and cardiac physiologists who manage patients implanted with pacemakers.Deadlines for actionsActions underway:20 February 2019Actions complete:13 May 2019Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.Remember : if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Device

Implantable cardiac pacemakers
  • Model / Serial
  • Product Description
    Brands distributed in the UK Models ADAPTA™ ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADVDD01 SENSIA™ SEDR01, SEDRL1 ATTESTA™ ATDR01 SPHERA™ SPDR01, SPDRL1 VITATRON™E, G, Q series E60A1, G70A2, Q70A2
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Manufacturer Address
    Medtronic Inc. Keith Taverner, Regulatory Affairs Manager UK and Ireland Tel: 01923 212 213 Email: [Vigilance.eu@medtronic.com](Vigilance.eu@medtronic.com)
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA