SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps - scan patients with these

(Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. (MDA/2008/087)

Central Alerting System (CAS) deadlines

Action underway: 19 January 2009, action complete: 17 March 2009

Device

Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637.

Problem

Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning.

Medtronic have found that the SynchroMed EL and SynchroMed II drug pumps do not behave as expected when they are exposed to the magnetic field of an MRI scan. The product labelling states that the magnetic field of an MRI scan will temporarily stop the rotor of the pump and suspend drug infusion for the duration of the MRI exposure for all SynchroMed pumps. The pump should resume normal operation when removed from the MRI magnetic field. However, the following issues have been found:

  • potential delay in resumption of drug infusion following an MRI scan (both models)
  • potential for pump programming to be altered (both models)
  • delay in logging of motor stall in the pump memory (SynchroMed II only)
  • delay in detecting motor stall recovery (SynchroMed II only)

There have been nine reported incidents of motor stall and 70 reports of event logging errors worldwide to date.

No patient deaths or serious injuries have been reported as a result of these problems.

Action

Ensure that departmental procedures are in place for the scanning of patients with Medtronic SynchroMed implantable drug pumps. Where prior consultation with pump management staff has not been possible, consider:

  • alternative imaging techniques if appropriate
  • more regular observations of the patient until confirmation that the pump has restarted.

For all personnel involved in the care of patients with these pumps:

  • Follow manufacturer’s advice regarding these risks (see appendix)

Before MRI

  • Ensure that an assessment has been undertaken to determine whether the patient could be safely deprived of their drug for the duration of the scan and until the pump can be interrogated
  • Ensure there is a Medtronic N’Vision programmer available to interrogate the pump as soon as possible after an MRI scan (and X-ray facilities for roller study on SynchroMed EL)

After MRI

  • Ensure that the patient and pump are reviewed promptly following scanning to confirm that therapy has resumed and that pump programming has not been affected. This could include:
    • close observation for signs of drug underdosing
    • for patients implanted with SynchroMed II pumps, interrogate the pump with the N’Vision programmer. If motor stall and recovery has not been confirmed after a second interrogation, contact the manufacturer for further advice
    • for patients implanted with SynchroMed EL pumps, interrogate the pump to identify whether programming has been affected and consider carrying out a roller study (as described in the IFU) to confirm that drug infusion has resumed
  • Before carrying out any medical intervention (e.g. administering a drug bolus or explanting the pump) consider the possibility of extended motor stall
  • Do not discharge patients until you have verified that normal drug infusion has resumed
  • Contact the manufacturer for advice if in doubt about pump status
  • Report drug pump incidents to the manufacturer and the MHRA

Distribution

Please bring this notice to the attention of all who need to know or be aware of it.

This may include distribution by:

Trusts to: CAS liaison officers for onward distribution to all relevant staff including:

Onward distribution

Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:

  • A&E departments (for information)
  • Clinical governance leads
  • Medical directors
  • Medical oncologists
  • MR radiographers
  • MR responsible persons
  • MR superintendent radiographers
  • MRI units, directors of
  • Nursing executive directors
  • Pain consultants
  • Radiation oncologists
  • Risk managers

Healthcare Commission (CHAI) to:

Headquarters for onward distribution to:

  • Hospitals in the independent sector

Manufacturer contact

Enquiries to the manufacturer should be addressed to:

Dr David Dunham
Regulatory Affairs Manager – UK & Ireland
Medtronic Limited
Suite One
Sherbourne House
Croxley Green Business Park
Watford WD18 8WW

Tel: 01923 212213
Fax: 01923 241004

E-mail: david.dunham@medtronic.com

England

Enquiries to the MHRA should quote reference number 2008/009/001/061/004 and be addressed to:

Technical aspects:

Michelle Kelly or Katy Hopkins
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3145 / 3176
Fax: 020 7084 3106

E-mail: michelle.kelly@mhra.gsi.gov.uk or katy.hopkins@mhra.gsi.gov.uk

Clinical aspects:

Dr Christopher Brittain
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

E-mail: christopher.brittain@mhra.gsi.gov.uk

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

E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible.

Further information about reporting incidents; online incident reporting facilities; and downloadable report forms are available from MHRA’s website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from MHRA Adverse Incident Centre

e-mail: aic@mhra.gsi.gov.uk

Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

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