Events

Safety Alert Or Field Safety Notices for Cardiac Resynchronization Therapy Pacing (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 Medtronic.

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
  • Date
    2015-12-09
  • Event Date Posted
    2015-12-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/cardiac-resynchronization-therapy-pacing-crt-p-risk-of-loss-of-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 has identified that an unpredictable, but very small, subset of InSync III devices may develop unexpectedly high and variable battery impedances, which can reduce the battery voltage to a point where the current is insufficient to support pacing output. Reported harms to date include bradycardia, dyspnoea, complete heart block, weakness and dizziness. Medtronic has received one report of a patient death where it is possible, but unconfirmed, that this issue was a contributing factor.There is no provocative testing that can predict which specific devices may fail, and there is no programming that can mitigate this issue. The failure results from the development of a resistive film on the cathode current collector. Development of the film is erratic and it is, therefore, not possible to identify a specific current drain above which the film will not develop and hence at which the devices are not at risk.To date Medtronic has received 30 reports of devices affected by this issue, which represents 0.03% of those distributed worldwide, all of which have involved devices with implant duration over 53 months. Medtronic predicts the failure rate will be between 0.16% and 0.6% for the remaining active devices, with an associated mortality risk of 0.007-0.02%. This should be compared to Medtronic’s estimated average mortality risk presented by early device replacement of around 0.005%, although clearly this will vary significantly depending upon the patient circumstances.Unfortunately the InSync III models are not supported by Medtronic’s Carelink network, and so it is not possible to review patients remotely.In the UK nearly 6,000 potentially affected devices have been supplied between June 2001 and October 2010 when this product was discontinued, and therefore most devices can be expected to have exceeded 4 years implant duration. To date there have been two incidents associated with this problem reported within the UK.Medtronic issued an FSN to affected hospitals on 10 November 2015 which includes patient management recommendations to mitigate the risk associated with this issue.
  • Reason
    Manufactured by medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - mda/2015/038.
  • Action
    Identify all affected patients. Schedule an early follow up to discuss this issue with the patient, with priority given to pacing dependent patients. Compare the risk presented by device failure against that associated with device replacement on an individual patient basis. Patient assessment should include review of the: degree of pacing-dependency estimated remaining device longevity/time to ERI applicability of the average mortality risk associated with device failure and device replacement, given by Medtronic (see background). Be aware that the low risk of device failure does not justify prophylactic replacement for the majority of non-pacing dependent patients. Repeat the above assessment at each follow-up appointment (intervals of 6 months or less). Remind patients to contact their follow-up centre if they experience increased symptoms of bradycardia or heart failure (including breathlessness) as this may be an indication of device failure.

Device

Cardiac Resynchronization Therapy Pacing (CRT-P)
  • Model / Serial
  • Product Description
    InSync III Models 8042U:Product description Unique device identifier IPG 8042U INSYNC III UNI INTL 00613994322524 IPG 8042U INSYNC III DC UNI EAME 00681490993364 IPG 8042U INSYNC III DC UNI EN/SV/DA 00681490993388 IPG 8042U INSYNC III DC UNI 5L 00681490993395 IPG 8042U INSYNC III DC UNI INTL 00681490993425
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Address
    Manufacturer:Keith Taverner Medtronic Limited Building 9, Hatters Lane Croxley Green Business Park Watford WD18 8WWTelephone: 01923 212 213Email: 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