TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) - identify patients affected recently
(Boston Scientific) Rapid battery depletion leads to risk of loss of therapy. (MDA/2014/039)
CAS deadlines
Action underway: 21 October 2014, Action complete: 4 November 2014
Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up and testing.
Device
TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.
The manufacturer has issued a (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.
| Device family | Affected model numbers | |
|---|---|---|
| COGNIS CRT-D | N106/N107/N118/N119/P106/P107/P108 | |
| TELIGEN DR ICD | E110/F110/F111 | |
| TELIGEN VR ICD | E102/F102/F103 |
You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.
Problem
Risk of loss of therapy due to rapid battery depletion. Additional serial numbers of devices are affected since the manufacturer’s original notification in August 2013.
In August 2013 Boston Scientific notified users about a subset of COGNIS™ CRT-Ds and TELIGEN™ ICDs that had experienced an increased rate of premature battery depletion due to a problem with a low voltage (LV) capacitor. The manufacturer has now identified a second subset of devices from subsequent clinical experience and analysis, which is expected to be affected by the same capacitor issue. This adds an additional 885 UK patients to the previous total of approximately 1,000 UK patients identified in August 2013.
With this FSN the manufacturer has also notified pacing clinics about the recent introduction of updated Safety Architecture software that will improve early detection of diminished LV capacitor performance. In particular this software enhances detection rates for ICDs later in their device life, and provides a new alert indicator on the programmer screen and the LATITUDETM remote patient monitoring system (if used).
The manufacturer has confirmed that the current prevalence of failures within the original advisory population has risen from 0.67% in August 2013 to 2% to date, with the newly identified devices expected to perform similarly. The latest FSN provides important additional information on cumulative survival rates* for devices both within and outside the advisory subset population to help with future patient management.
*United States data, correct up to 21 July 2014
Action
- Identify newly affected patients according to Boston Scientific’s latest or look-up tool and schedule them for an in-clinic visit as soon as possible (within 3 months at the latest).
- Interrogate the device using a programmer which has received the new software provided by Boston Scientific. This will automatically download improved software for detecting a failing capacitor.
- If a ‘Code 1003’ alert is seen on the programmer screen, contact Boston Scientific Technical Services to help clarify the time to ‘End Of Life’ (EOL) of the device. Note that ‘Approximate time to Explant’ and ‘Time Remaining’ estimates displayed on the programmer are not accurate when this capacitor malfunction has occurred.
- Schedule device replacement taking into account time to EOL prediction provided by Boston Scientific.
- Ensure that all audible alerts have been programmed ‘ON’ and remind patients to contact their clinics immediately if they hear beeping.
- Consider the benefits of monitoring patients at home using the LATITUDE™ Patient Monitoring System.
- Schedule patients already identified by MDA/2013/072 for follow-up within 3 months to download their ICDs with the improved software for detecting a failing capacitor.
- This notice replaces MDA/2013/072 issued in September 2013.
Note:
Prophylactic replacement of these devices is not recommended
Action by
All cardiologists and cardiac physiologists who manage patients implanted with ICDs and CRT-Ds.
Distribution
This MDA has been sent to:
- Clinical commissioning groups (CCGs)
- HSC trusts in Northern Ireland (chief executives)
- NHS boards and trusts in Wales (chief executives)
- NHS boards in Scotland (equipment co-ordinators)
- NHS England area teams for information
- NHS trusts in England (chief executives)
- Special health authorities for information
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:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Cardiac laboratory technicians
- Cardiac pacing technicians
- Cardiologists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Clinical governance leads
- Coronary care departments
- Coronary care nurses
- Nursing executive directors
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Hospitals in the independent sector
- 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
Lisa Austin
Boston Scientific
Breakspear Park
Breakspear Way
Hemel Hemsptead, HP2 4TZ
Tel: 01442 411 600
Email: UK-Quality@bsci.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/2014/039 or 2013/008/029/291/001
Technical aspects
Guido Fumagalli or Simon Holmes
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7144 or 7240
Fax: 020 8754 3965
Email: guido.fumagalli@mhra.gsi.gov.uk or simon.holmes@mhra.gsi.gov.uk
Clinical aspects
Dr Camilla Fleetcroft
Medicines & Healthcare Products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 6097
Fax: 020 8754 3965
Email: camilla.fleetcroft@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
http://www.dhsspsni.gov.uk/index/hea/niaic.htm
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 3922
Email: Haz-Aic@wales.gsi.gov.uk
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