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MDA/2005/070 - Guidant INSIGNIA and NEXUS implantable pacemakers

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/070
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/070
Issued: 19 December 2005

IMMEDIATE ACTION Tick mark
ACTION  
UPDATE Tick mark
INFORMATION REQUEST  


This alert is an update to MDA/2005/067 issued on 08 December 2005.

 Further Information
DEVICE:
Guidant INSIGNIA and NEXUS implantable pacemakers - see list of affected serial numbers distributed in the UK on our website.

>
PROBLEM:
Recall due to component failure.		  

>
ACTION BY:
All cardiologists and cardiac physiologists who implant these devices.		  

ACTION:

  • Do not implant affected INSIGNIA or NEXUS implantable pacemakers Review stocks of INSIGNIA and NEXUS implantable pacemakers and identify those included in the recall.
  • Immediately quarantine affected devices and return them to Guidant in accordance with their instructions.
  • Report all instances of devices failure to MHRA and Guidant.
  

>

DISTRIBUTED to:

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

* via CE Bulletin

  

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CONTACTS:
Details of manufacturer and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.		  

>


> Further information supplied in the following pages.

Page last modified: 07 February 2008