Implantable pulse generators (IPGs) neurostimulators - confirm actions from field safety notice

(St Jude Medical) manufacturer not received sufficient confirmation of action after a field safety notice was sent out on the faulty battery components that could result loss in ability to communicate with the programmer or recharge in some IPGs. (MDA/2011/079)

Device

Medical Device Alert: Implantable Pulse Generators (IPGs) – Neurostimulators manufactured by St Jude Medical (MDA/2011/079)

Implantable Pulse Generators (IPGs) – Neurostimulators. Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788).

Manufactured by St Jude Medical.

Problem

Faulty battery components have resulted in some IPGs losing the ability to communicate with the programmer or recharge. In the cases reported, the duration between recharges became progressively shorter until the IPG failed to charge or there was a sudden loss of power, which resulted in the need for device replacement. The time from manufacture of affected devices to explant has so far ranged from eight months to two years.

Action

  • Read the manufacturer’s Field Safety Notice (FSN) (226Kb)
  • Identify affected patients using the list of serial numbers within the FSN
  • Review affected patients and advise them to contact their clinician immediately in the event of a sudden loss of device power
  • Patients fitted with devices that are noted to have a shorter duration between recharges should be considered for a replacement device on an individual

Action by:

  • Implanting surgeons and clinicians involved in the management and follow-up of patients with these devices
  • Neurologists
  • Neurological surgeons
  • Chronic pain consultants

Distribution

This MDA has been sent to: 

  • NHS trusts in England (Chief Executives)
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Equipment Co-ordinators)
  • Local Authorities in Scotland (Equipment Co-ordinators)
  • NHS boards and trusts in Wales (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:

  • Chronic pain consultants
  • Medical directors
  • Neurological surgeons
  • Neurologists
  • Nursing executive directors

For information only 
General practitioners

Independent distribution

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

Sean Hogarth
St Jude Medical UK Ltd
Capulet House
Stratford Business and Technology Park
Stratford Upon Avon CV37 7GX

Tel: 01789 207 611
Fax: 01789 207 601

Email: SHogarth@SJM.com

Feedback

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

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/079 or 2011/005/024/081/002.

Technical aspects

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

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

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

Clinical aspects

Dr Nicola Lennard 
Medicines and 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: Implantable Pulse Generators (IPGs) – Neurostimulators manufactured by St Jude Medical (MDA/2011/079) (335Kb)

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