FOI release

Freedom of Information request on Barnet Hospital notifying them of a defect with some of their St Jude pacemaker models (FOI 21/1269)

Published 31 May 2022

FOI 21/1269

20th December 2021

Dear,

Thank you for your information request, dated 27 November and 7 December, where you asked for:

(1)   On the 15th March 2021, Abbott, wrote to Barnet Hospital notifying them of a defect with some of their St Jude pacemaker models and confirming that they would notify the regulatory agencies about the matter (see attached letter, second paragraph). I want to know if they also filed a device list (model serial numbers) with the MHRA, and if so, I would like to receive a copy of it under FOI Act.

(2)   Sometime in late 2020 Barnet Hospital made a defective-pacemaker report to the MHRA in relation to me. I do not believe that I was a named in the report but a relevant pacemaker serial number would have been reported. I would like disclosure of that report under FIO. If I was named, I will make a separate request under GDPR. Please confirm.

I am pleased to provide you with the following information , see below.

• Abbott notified MHRA of the Field Safety Corrective Action concerning potential moisture ingress in a subset of Assurity and Endurity pacemakers on March 15 2021.  You can see the Field Safety Notice on Gov.uk here:

https://www.gov.uk/drug-device-alerts/field-safety-notices-15-to-19-march-2021#abbott-assurity-endurity

You will see it is the same Field Safety Notice you attached in your email to MHRA on 7 December.  The MHRA were not provided with a list of serial numbers affected.  To determine which devices were affected, Abbott provided an online device lookup tool which you can find here: https://www.cardiovascular.abbott/us/en/hcp/product-advisories/pacemaker-lookup.html

• MHRA are only able to share report details or outcomes with the original reporter. We are unable to provide you reporter’s personal information or details of the report as the information is exempt from release under sections 40 and 41.

Section 40 – Personal information: Section 40 protects personal data, the disclosure of which would breach one or more of the data protection principles. The Agency is satisfied that disclosure here would breach the first data protection principle, in particular the requirement of fairness on the basis that disclosure would not be reasonably expected by the people mentioned in the information.

Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.

We recommend you contact Barnet Hospital for the information on the report they have made.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000