(Guidant) component failure. (MDA/2005/070)
This alert is an update to MDA/2005/067 issued on 08 December 2005.
Deadline (Action underway): 20 January 2006 Action plan to be agreed and actions started.
Deadline (Action complete): 20 April 2006 All actions to be completed.
Guidant INSIGNIA and NEXUS implantable pacemakers - specific serial numbers distributed in the UK
Due to the number of products involved it is not possible to include the list of serial numbers on this page. A comprehensive list of serial numbers of affected devices distributed in the UK can be found in the following attachments:
Recall due to component failure.
The information provided in this alert is an update to the information provided in MDA/2005/067 issued on 08 December 2005 which advised of two failure modes, which were described as: ‘First failure mode’ and ‘Second failure mode’.
This Alert provides updated information concerning the second failure mode. There is no change to previous information provided about the first failure mode.
Guidant has initiated a world-wide recall of certain INSIGNIA and NEXUS implantable pacemakers and has now identified why a subset of these devices exhibits no output conditions during verification testing prior to implant or during the implantation procedure (the second failure mode).
Guidant has identified that these devices can malfunction if they incorporate a defective crystal timing component manufactured by one of two suppliers.
Guidant has determined that a problem with the manufacturing process of this component can, in rare instances, result in a microscopic particle of quartz crystal entering the internal cavity of the crystal timing component. This particle can electrostatically attach to the inner surface of the crystal casing and subsequently detach through normal handling or during transit. The loose particle can then adhere to the crystal tuning mechanism causing crystal malfunction, and consequential malfunction of the master oscillator circuit that controls all pacemaker timing functions. Malfunction of the master oscillator will result in intermittent/permanent loss of pacing or telemetry.
Although all models of INSIGNIA and NEXUS implantable pacemakers are affected, this recall is restricted to those devices that have been assembled using defective crystal timing components (see list of affected serial numbers distributed in the UK on our website).
To date, Guidant has received 17 confirmed reports of device malfunction out of 257,000 devices distributed worldwide. These all occurred at pre-implant testing or during the implantation procedure.
There have been no reports of device malfunction in the UK at pre-implant testing or during the implantation procedure. The number of potentially affected devices in the UK is approximately 8,000.
Since all failures have occurred before or during the implantation procedure neither Guidant nor MHRA advise additional follow-up for successfully implanted devices at this time.
Guidant also issued updated information related to this problem to UK clinicians on 16 December 2005 (see Appendix 1).
MHRA will continue to monitor the situation and will consider issuing further advice.
- Do not implant affected INSIGNIA or NEXUS implantable pacemakers Review stocks of INSIGNIA and NEXUS implantable pacemakers and identify those included in the recall.
- Immediately quarantine affected devices and return them to Guidant in accordance with their instructions.
- Report all instances of devices failure to MHRA and Guidant.
All cardiologists and cardiac physiologists who implant these devices.
- NHS Trusts (England) - Chief Executives
- Healthcare Commission (CHAI) - Headquarters
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:
- Liaison officers (for onward distribution)
- Accident & emergency departments
- Cardiac pacemaker/ICD physiologists
- Cardiologists with pacemaker/ICD responsibilities
- Cardiothoracic surgeons
- Clinical governance leads
- Medical directors
- Nursing executive directors
- Risk managers
HEALTHCARE COMMISSION (CHAI) to:
- Headquarters (for onward distribution)
- Hospitals in the independent sector
Enquiries to the manufacturer should be addressed to:
Ms Jayne Puckeridge Regulatory Affairs Manager Guidant Limited Hampshire International Business Park Crockford Lane Chineham Basingstoke RG24 8WH
Tel: 01256 374 010Fax: 01256 374 014
Enquiries to the MHRA should quote reference number 2005/009/027/291/007 and be addressed to:
Miss Andleeb Arshad or Mr Peter Solesbury, Medicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ
Tel: 020 7084 3145/3215 Fax: 020 7084 3106
Dr Susanne Ludgate Medicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ
Tel: 020 7084 3123 Fax: 020 7084 3111
Change of address or removal from address list for Healthcare Commission
Healthcare Commission, Finsbury Tower, 103-105 Bunhill Row, London EC1Y 8TG
Tel: 020 7448 0842
All appendices are contained in the attached PDF files: