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MDA/2008/087 - Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/087
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 11
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 18 December 2008 at 11:30
Ref: MDA/2008/087

 

 
Immediate action
    Tick mark Action
 
Update
 
Information request


 

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.

>Page 2

Action by:
All MRI radiologists, radiographers and technicians responsible for carrying out MRI scans. All clinicians involved in managing patients implanted with SynchroMed drug pumps.

  

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.
  

>Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) – Headquarters
NHS Boards in Scotland - Chief Executives

* via CE Bulletin

 >Page 3
Contacts:
Details of manufacturer contacts and contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 3
Appendix:
Manufacturer’s Field Safety Notice (August 2008) (in pdf only).

>Pages 5-11

 

Action deadlines for the Central Alerting System (CAS)
Deadline (action underway): 19 January 2009
Deadline (action complete): 17 March 2009

Page last modified: 19 December 2008