Implantable pacemakers - residual longevity overestimated

(Sorin) Difference between predicted and actual pacemaker battery depletion characteristics. (MDA/2013/084)

CAS deadlines

Action underway: 7 January 2014, action complete: 21 January 2014

Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up.

Device

Implantable pacemakers manufactured by Sorin.

REPLY – models D, DR, VDR, SR
ESPRIT – models D, DR, S, SR

Problem

Risk of loss of pacing due to overestimation of the time remaining to elective replacement indicator (ERI).

Sorin has received 8 reports where the residual longevity determined during follow-up was overestimated due to a software inaccuracy. This has arisen as a result of a difference between predicted and actual pacemaker battery depletion characteristics. All reports reached ERI within 4 to 5 years and involved pacemakers programmed with high pulse amplitude and width, combined with a high percentage of paced events.

Over 20,000 pacemakers affected by this issue have been distributed in the UK since 2007.

The manufacturer has determined that the majority of affected pacemakers should not reach ERI within 8 years of implantation. However, it is important to note that this time may be significantly reduced for pacemakers with high programmed settings, for example in the case of pacing-dependent patients. It is also important to be aware that there are differences in nominal longevity between the pacemaker models (under Cenelec conditions of 70 min-1, 2.5V, 0.5ms). Reply DR and Reply D models have an expected nominal longevity of less than 8 years; being 7.1 and 7.4 years respectively, compared with Reply VDR and Reply SR at 9 years and 9.3 years respectively. Within the UK approximately 250 Reply DR and Reply D models were sold over 6 years ago. Early implants of these pacemaker models may be among the first to reach ERI, especially where they have a high percentage of pacing and/or high output settings.

The manufacturer will be issuing a new programmer software version to correct the quoted time to ERI and its presentation through the colour-coded gauge. All upgrades are expected to be completed in the UK within three months. However, the need for 6 monthly follow-up when the battery impedance reaches 3.5kΩ will remain.

Sorin distributed a Field Safety Notice (40Kb) concerning this issue to affected customers on 20 November 2013.

Action

Review the last follow-up exam for all patients implanted with an affected pacemaker.

Schedule three-month follow up:

  • for those patients whose battery impedance displayed a value greater than or equal to 3.5kΩ. Priority should be given to pacemaker-dependent patients and those with high programmed settings
  • if the last follow up was carried out without the use of a programmer and the magnet rate was less than 95 min-1.

Once Sorin has upgraded your programmer software:

  • obtain an accurate residual longevity reading by following up all patients within three months
  • continue with six-monthly follow-ups where pacemaker battery impedance becomes greater than or equal to 3.5kΩ.

Action by

All cardiologists and cardiac physiologists who manage patients implanted with pacemakers.

Distribution

This MDA has been sent to:

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • NHS 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 pacing technicians
  • Cardiac physiologists
  • Cardiologists
  • Cardiology departments
  • Cardiology nurses
  • Cardiology, directors of
  • Clinical governance leads
  • Medical directors
  • Nursing executive directors
  • Risk managers

NHS England area teams 
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

Elodie Vincent
Sorin CRM
Parc d'affaires NOVEOS
4, Avenue Réaumur
92143 Clamart Cedex
Tel: +33 1 46 01 36 65

Email: crm.complaints@sorin.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/2013/084 or 2013/011/021/291/004

Technical aspects

Michelle Kelly or Simon Holmes or Hazel Randall
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7145 / 7240 / 7287
Fax: 020 8754 3965

Email: michelle.kelly@mhra.gsi.gov.uk, simon.holmes@mhra.gsi.gov.uk or hazel.randall@mhra.gsi.gov.uk

Clinical aspects

Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road, London SW1W 9SZ
Tel: 020 3080 7032 / 7248
Fax: 020 8754 3965

Email: kayleigh.purdon@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

All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.

Other enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
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

Incident Reporting and Investigation Centre

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 5801

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: Implantable pacemakers manufactured by Sorin. (MDA/2013/084) (146Kb)

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