Field Safety Notices & Medical Device Alerts

This section outlines important clarification from the
Medicines & Healthcare Products Regulatory Agency (MHRA)

Who is Responsible for implementing Field Safety Notices (FSN) and Medical Device Alerts (MDA)?

It is the medical device manufacturer that is legally responsible for identifying when they need to undertake field action to address a safety risk with their devices. They should always issue a Field Safety Notice (FSN) when they do so to explain what they are doing and why. For cardiac implantable electronic devices (CIEDs) companies usually target their FSN to all customers or centres they can identify who received the devices or are managing affected patients. So some FSNs, affecting many patients, go to a large number of UK pacing centres, while others may be targeted to only a few.

As the regulatory authority MHRA is responsible for monitoring the action taken by the manufacturer. They will only issue a Medical Device Alert (MDA) if this will add value to the action already taken by the manufacturer. In rare circumstances MHRA will issue an MDA because there is no FSN, such as if the company no longer exists, does not recognised there is a problem, or if the concern is generic to a device type rather than to specific device models. MHRA reviews the FSN to help decide if they need to take any extra action. Criteria for when an MDA is issued following an FSN include: where additional advice or clarification would be helpful; where the message needs to reach a wider number of centres; if there is concern that the FSN may not have been appropriately received; or if an issue is sufficiently high profile or high risk that an MHRA opinion is expected.

On average around 2 FSNs are issued in the UK on CIEDs per month, whereas as it can be as few as 1 or 2 per year that are followed by an MDA. It is therefore important that centres pay urgent attention to any FSNs they receive, and don’t wait for an MDA. This includes responding to the manufacturer’s request for confirmation that the message has been received and understood.

IMPORTANT CLARIFICATION

Please ensure you read this page carefully. It contains important clarification from the Medicines and Healthcare Products Regulatory Agency (MHRA)

Field Safety Notice: MEDTRONIC

Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ cardiac resynchronization therapy pacemakers (CRT-P) Performance Note Low Voltage Capacitor (May 2019)
PERFORMANCE NOTE (May 2019) Potential for no output/no telemetry condition in subset of IPG and CRT-P products due to ceramic capacitor leakage pathway.

Medical Device Alert: MEDTRONIC

Implantable cardiac pacemakers: specific brands of dual chamber pacemakers – risk of syncope due to pause in pacing therapy (Feb 2019)

Field Safety Notice: MEDTRONIC

For a Subset of Medtronic Dual Chamber Pacemakers (Jan 2019)

Medical Device Alert: BOSTON SCIENTIFIC

Pacemakers and CRT-P – oversensing of minute ventilation sensor signal leading to risk of syncope and pre-syncope (Jan 2018)

Field Safety Notice: BOSTON SCIENTIFIC

Pacemakers – Technical Programming Information on Minute Ventilation Sensor (Dec 2017)

Field Safety Notice: ABBOTT

Battery Performance Management Tool for Implantable cardioverter Defibrillator with Risk of Premature Battery Depletion from Lithium Cluster Induced Shorts (Aug 2017)

Field Safety Notice: ABBOTT

Information About Cybersecurity Update (Aug 2017)
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