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MDA/2008/038 - Implantable drug pumps for intrathecal therapy. All manufacturers

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/038
Audience: Healthcare professionasl
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 09 June 2008 at 11:30
Ref: MDA/2008/038

 

 
Immediate action
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Action
 
Update
 
Information request


Device:
Implantable drug pumps for intrathecal therapy. All manufacturers.		  
Problem:
Risk of temporary or permanent neurological impairment due to inflammatory or granulomatous mass formation at the catheter tip.

>Page 2
Action by:
All healthcare professionals who are involved in the implantation and/or management of patients with implantable intrathecal drug pumps in hospitals and refill clinics.		  

Action:

  • Consider inflammatory mass or granuloma formation in the intrathecal space as a possible cause of any new neurological symptoms or loss of analgesic effect in patients receiving intrathecal drug therapy.
  • Consider prompt diagnostic imaging to confirm the diagnosis of an inflammatory or granulomatous mass in these patients who would then need early neurosurgical referral.
  • Ensure patient dose remains at minimum level to be clinically effective.
  • Consider reducing concentration of intrathecal opioids as far as possible.
  • Follow the patient management and system troubleshooting guidelines given by the pump manufacturer.
  • Report any incidents involving mass formation to the relevant drug pump manufacturer and the MHRA.
  

Distributed to:

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

* via CE Bulletin

>Page 2
Contacts:
Details of MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 3


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 07 July 2008
Deadline (action complete): 09 September 2008


Page last modified: 09 June 2008