INSIGNIA and NEXUS implantable pacemakers - consider replacement of elective device if there are one or more malfunctions

(Guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI), and/or reset warning message upon interrogation. (MDA/2005/067)

Deadline (Action underway): 11 January 2006 Action plan to be agreed and actions started.

Deadline (Action complete): 11 April 2006 All actions to be completed.

Device

Guidant INSIGNIA and NEXUS implantable pacemakers.

Guidant Pacemakers

Device Family Model Numbers
INSIGNIA Entra SSI 0484, 0485
INSIGNIA Entra DDD 0985, 0986
INSIGNIA Entra SR 1195, 1198
INSIGNIA Entra DR 1294, 1295, 1296
INSIGNIA Ultra SR 1190
INSIGNIA Ultra DR 1290, 1291
INSIGNIA Plus SR 1194
INSIGNIA Plus DR 1297, 1298
INSIGNIA AVT SSI 482
INSIGNIA AVT VDD 882
INSIGNIA AVT DDD 982
INSIGNIA AVT SR 1192
INSIGNIA AVT DR 1292

Guidant Intermedics Pacemakers

Device Family Model Numbers
NEXUS Entra SSI 1325, 1326
NEXUS Entra DDD 1425, 1426
NEXUS Entra SR 1395, 1398
NEXUS Entra DR 1466, 1494, 1495
NEXUS Ultra SR 1390
NEXUS Ultra DR 1490, 1491
NEXUS Plus SR 1394
NEXUS Plus DR 1467, 1468
NEXUS AVT SSI 1328
NEXUS AVT VDD 1428
NEXUS AVT DDD 1432
NEXUS AVT SR 1392
NEXUS AVT DR 1492
  • NB. Not all models are available in the UK

A list of UK serial numbers for devices distributed on or before 12 March 2004, affected by the first failure mode can be found in Appendix 1.

Problem

Device may exhibit:

  • intermittent or permanent loss of pacing output without warning
  • intermittent or permanent loss of telemetry
  • reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.

Guidant has informed MHRA that all INSIGNIA and NEXUS implantable pacemakers may be subject to either one or two separate failure modes each having a different root cause.

Affected devices will exhibit one or more of the following:

  • intermittent or permanent loss of pacing output without warning
  • intermittent or permanent loss of telemetry
  • reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.

Although there have been no reports of death as a result of these failure modes, serious health complications may result from the abnormal device behaviours associated with these failure modes.

Details of the two failure modes are described below:

First failure mode

Guidant has identified the potential for loss of pacing output and/or telemetry in a subset of INSIGNIA and NEXUS devices distributed prior to 12 March 2004.

Guidant has confirmed that the root cause of this malfunction is the obstruction of a crystal timing component by loose material used in the component’s manufacturer. When this timing component is disrupted all device operations such as pacing, telemetry and magnet response may be prevented and the device can cease to function.

To date, all device malfunctions associated with this failure mode have occurred within the first 22 months of implantation. Guidant believes that the likelihood of this malfunction occurring decreases with implant time, with a mean time to failure of seven months.

Device failure is rare. As of November 2005, Guidant has received three reports of syncope and six reports of bradycardia requiring emergency hospitalisation. Engineering analysis by Guidant of an explanted device revealed that it had failed briefly but then resumed functioning with no detectable indication to the physician during routine follow-up.

Guidant has received 37 confirmed reports of device malfunction associated with this failure mode: 7 devices exhibited a no output condition during the implant procedure; 21 devices exhibited a no output condition post implant procedure and 9 devices reverted to VVI pacing at 65 bpm.

Out of 49,500 devices distributed prior to 12 March 2004, Guidant estimates that approximately 41,000 devices remain implanted, with approximately 2,200 implanted in the UK.

Guidant predicts that up to 14 additional devices may malfunction worldwide over the remaining lifetime of the implanted products. Guidant has ensured corrective measures to address this issue have been implemented.

MHRA has received two UK reports of syncope associated with these devices. Guidant issued information related to this problem to UK clinicians on 29 September 2005 (see Appendix 2).

Second failure mode

Guidant has identified that all INSIGNIA and NEXUS devices may exhibit a no output condition during verification testing prior to implant or during implantation. No malfunctions have been observed after successful verification of the device at implant.

As of November 2005, Guidant has received 17 confirmed reports of device malfunction at pre-implant testing or during implantation out of approximately 341,000 devices distributed worldwide. In one (non-UK) report a pacemaker dependent patient experienced syncope and was resuscitated following cardiac arrest. This was associated with loss of pacing output during an elective pacemaker replacement procedure.

There have been no reports of device malfunction at pre-implant testing or during implantation in the UK to date. The number of potentially affected devices in the UK is approximately 11,000.

Guidant has yet to determine a specific root cause for this failure mode and continues to investigate this failure.

Guidant will issue further advice when more information is available.

Guidant also issued information related to this problem on 29 September 2005 (see Appendix 2).

MHRA will continue to monitor both these situations.

Action

First failure mode (see list of affected devices in Appendix 1)

  • identify and review all patients implanted with affected pacemakers as soon as possible, giving priority to those who are pacemaker dependent or who have not been followed up within the last six months
  • instruct patients to contact their follow-up centre immediately, or to go to a hospital Accident and Emergency department if they experience a slow heart rate, syncope/light headedness, or new or increased symptoms of heart failure
  • during follow-up, verify device function using normal programmer follow-up procedures, checking for:
    • intermittent or permanent loss of telemetry/pacing output
  • reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.
  • consider elective device replacement if one or more of the above malfunctions is confirmed
  • consider elective device replacement for pacemaker dependent patients
  • schedule future pacemaker follow-ups at intervals of no longer than 6 months for early detection of device failure.

Second failure mode (all devices)

  • verify device function when the device is still in its packaging prior to the implant procedure
  • do not implant if device function verification confirms intermittent or permanent loss of telemetry/pacing output.

Report all instances of device failure to MHRA and Guidant.

Report all explants to the National Pacing and ICD Database (see contacts).

Action by

All cardiologists and cardiac physiologists who manage patients already implanted with or to be implanted with these devices.

Distribution

  • 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:

TRUSTS to:

  • Liaison officers (for onward distribution)
  • Accident & emergency departments
  • Cardiac pacemaker/ICD physiologists
  • Cardiologists with pacemaker/ICD responsibilities
  • Clinical governance leads
  • Medical directors
  • Nursing executive directors
  • Risk managers

HEALTHCARE COMMISSION (CHAI) to:

  • Headquarters (for onward distribution)
  • Hospitals in the independent sector

Contacts

Details of manufacturer, MHRA contacts for technical and clinical aspectsChange of address or removal from address list for Healthcare Commission.

Manufacturer

Enquires to the manufacturer, National Pacing and ICD Database should be addressed to:

Ms Jayne Puckeridge Regulatory Affairs Manager, Guidant Limited, Hampshire International Business Park, Crockford Lane, Chineham, Basingstoke, Hampshire, RG24 8WH

Tel: 01256 374 010, Fax: 01256 374 014

E-mail: jpuckeri@guidant.com

National Pacing and ICD Database, PO Box 9205, Bridge of Weir, Strathclyde, PA11 3DZ

Tel: 01505 612 829Fax: 01505 612 829

E-mail: mwc@btconnect.com

MHRA

Enquiries to the MHRA should quote reference number 2005/009/027/291/027 and be addressed to:

Technical aspects

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

E-mail:andleeb.arshad@mhra.gsi.gov.ukpeter.solesbury@mhra.gsi.gov.uk

Clinical aspects

Dr Jon Hopper Medicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ

Tel: 020 7084 3126, Fax: 020 7084 3111

E-mail:jon.hopper@mhra.gsi.gov.uk

Change of address or removal from address list for the Healthcare Commission

Healthcare Commission, Finsbury Tower, 103-105 Bunhill Row, London EC1Y 8TG

Tel: 020 7448 0842

E-mail: contact@healthcarecommission.org.uk

Appendix

Appendix 1 and 2 are available in the following PDF file:

MDA/2005/067 - Guidant INSIGNIA and NEXUS implantable pacemakers

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