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MDA/2007/042 - External pacemakers and temporary cardiac pacing leads

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/042
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

We are concerned that some insecure adaptor systems are still being used to connect temporary pacing leads to external pacemakers.
 

Issued: 23 May 2007 at 15:30

Ref: MDA/2007/042

 

 
Immediate action
 Tick mark 
Action
 
Update
 
Information request


Device:
External pacemakers and temporary cardiac pacing leads.

 
Problem:
Potential for loss of pacing due to accidental disconnection of temporary pacing leads and lead adaptors.		  

>Page 2  

Action by:
Cardiologists, cardiothoracic surgeons, cardiac physiologists and biomedical engineering departments.

  

Action:

  • Ensure that the connectors on temporary cardiac pacing leads and external pacemaker are compatible. Do not use lead adaptors.
  • Under exceptional circumstances where the use of an adaptor is unavoidable, use only an adaptor that incorporates a retention mechanism, which prevents accidental disconnection.
  • Note that the recommendations in this MDA supersede the advice given in Safety Notice SN2002(015) issued in May 2002.
  

Distributed to:

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

* 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): 27 June 2007
Deadline (action complete): 26 September 2007


Page last modified: 23 May 2007