Dual Chamber Pacemakers - confirm actions with manufacturer after receipt of field safety notices

(Medtronic Ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (Reference: FA507). (MDA/2011/060)

Device

Dual Chamber Pacemakers.

Medtronic models:
Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia.

Vitatron models:
E50A1, E60A1 and G70A1.

Problem

The manufacturer issued a Field Safety Notice (FSN) – Medtronic Reference: FA507 (675Kb) – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information.

A copy of the FSN is in the appendix of this Alert, and it is also available on the MHRA website.

Action

  • Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.

Distribution

This MDA has been sent to:

  • NHS trusts in England (Chief Executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Equipment Co-ordinators)
  • NHS boards and trusts in Wales (Chief Executives)
  • Primary care trusts in England (Chief Executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Cardiac laboratory technicians
  • Cardiac physiologists
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Clinical governance leads
  • Medical directors
  • Nursing executive directors
  • Risk managers

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • General practitioners

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Manufacturer contact

Lezlie Bridge
Medtronic Ltd
Building 9
Croxley Green Business Park
Hatters Lane
Watford
WD18 8WW

Tel: 07740 899 216
Fax: 01923 225 273

Email: lezlie.j.bridge@medtronic.com

Feedback

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk 

Appendix

Medtronic Field Safety Notice (357Kb)

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/060 or 2011/004/004/081/023.

Technical aspects

Miss Feza Haque or Mr Simon Holmes
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7066 / 7240
Fax: 020 8754 3965

Email: feza.haque@mhra.gsi.gov.uk and simon.holmes@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices.

Further information about CAS can be found on the CAS website

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website .

Further information about SABS can be found on the SABS website .

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) 

Wales

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: Dual Chamber Pacemakers. Manufactured by Medtronic Ltd (MDA/2011/060) (722Kb)

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