Issued: 22 October 2003
Medtronic SynchroMed® Implantable Drug Pump.
MHRA is aware of five incidents in the United Kingdom where the use of diamorphine solution has resulted in malfunction of the SynchroMed® pump. In four of these incidents, pump malfunction led to cessation of drug delivery (motor stalling) resulting in return of patient symptoms. In the remaining incident (still under investigation) pump malfunction led to over-infusion of diamorphine solution and the patient suffered a cardiorespiratory arrest.
Failure analysis of the four cases of motor stalling by Medtronic has shown that motor stalling was associated with the long-term administration of diamorphine solution, where the materials of the internal components were damaged. Diamorphine (diacetyl morphine) in aqueous solution will degrade over time, producing an insoluble active compound (6-monoacetyl morphine), which is an acetate and is believed to have caused the damage to the pump.
Current Instructions for Use for the SynchroMed® implantable drug pump do not include diamorphine in the list of medications that are compatible with the pump.
In October 2002 Medtronic distributed an “Educational Brief: Revised Drug Formulation SynchroMed® Infusion System”, which listed drugs and additives known to be incompatible with the SynchroMed® implantable drug pump. Diamorphine was not included in this listing since its adverse effect had not been recognised at that time. To clarify this situation Medtronic plans to distribute further information shortly.
It is estimated that there are 1200 SynchroMed® drug pumps currently implanted in the UK.
All clinicians that implant or manage patients implanted with SynchroMed® implantable
drug pumps, and pharmacists
For patients currently receiving diamorphine solution via the SynchroMed® pump, clinicians should consider :
- changing to an alternative medication compatible with the pump as soon as possible (note that changing the patient’s medication requires careful assessment and observation by experienced personnel);
- elective replacement of the pump when patient management dictates.
- Clinicians should be aware that other drugs are contraindicated for delivery via SynchroMed® implantable drug pumps. Where doubt exists, check the instructions for use as supplied with the pump, or seek manufacturer’s advice.
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)
- Medical directors
- Nursing executive directors
- Directors of anaesthetics
- Directors of radiotherapy/oncology
- Neurologists and neurological surgeons
- Medical oncologists
- Clinicians involved with pain clinics
- Theatre managers
- Adult & paediatric intensive care units
- Accident & emergency departments
- Health & safety officers
- Risk managers
- Clinical governance leads
NATIONAL CARE STANDARDS COMMISSION to:
- Headquarters (for onward distribution)
- Care homes providing personal care
- Care homes providing nursing care
- Domiciliary care providers
- Hospitals in the independent sector
Enquiries to the manufacturer should be addressed to:
Mr Jacques Thielen
Medtronic Bakken Research Center BV
6220 GW Maastricht
Tel: 0031 43 3566 756
Fax: 0031 43 3566 504
Enquiries to the MHRA should quote reference number 2003/007/023/121/003 and be addressed to:
Dr Crina Cacou or Mr Peter Solesbury
Medicines & Healthcare products Regulatory Agency
Elephant and Castle
London SE1 6TQ
Tel: 020 7972 8338 / 8215Fax: 020 7972 8106
Dr Jon HopperMedicines & Healthcare products Regulatory Agency
Elephant and Castle
London SE1 6TQ
Tel: 020 7972 8126Fax: 020 7972 8103
Change of address or removal from list for services registered under the Care Standards Act 2000
NCSC Customer Service Unit
St Nicholas Building
St Nicholas Street
Tel: 0191 233 3556
MDA/2003/035 - Medtronic SynchroMed® Implantable Drug Pump