FOI release

Freedom of Information request on data regarding Heartware devices (FOI 21/1101)

Published 27 April 2022

18th October 2021

FOI 21/1101

Dear

Thank you for your information request, dated 28/9/21.

I have copied your questions below.

a) Please provide details of any investigations carried out into Heartware devices since they were first used in the UK. Please include the date, nature and outcome of the investigation and any regulatory action taken as a result, as well as details of the adverse incident report / intelligence that led to the investigation

b) Please provide copies of any compliance notices issued to Heartware / Medtronic over the same period, and the responses received from the company

c) Has the MHRA conducted any internal reports into the safety of these devices? If so, please provide a copy of these documents

Unfortunately, the information that you’ve requested asked in questions a) and c) is exempt from release under section 44 of the Freedom of Information (FOI) Act due to Prohibitions on Disclosure.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

• constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

• relates to the affairs of Medtronic, a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies, and the information is exempt from release.

I can also confirm that we do not hold the information that you have requested in question b)

You can find Field Safety Notices (FSNs) published by Heartware here https://www.gov.uk/drug-device-alerts

FSNs are legally required to be published by a medical device manufacturer when they are undertaking Field Safety Corrective Action. Further information on Field Safety Corrective Actions can be found here https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

If you have a query about this, please reply to this email.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk. Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices. Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU