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MDA/2005/067 - Guidant INSIGNIA and NEXUS implantable pacemakers

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/067
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 15
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/067
Issued: 08 December 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Guidant INSIGNIA and NEXUS implantable pacemakers.

 >

PROBLEM:
Device may exhibit:

  • intermittent or permanent loss of pacing output without warning
  • intermittent or permanent loss of telemetry
  • reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.
  

 >
ACTION BY:
All cardiologists and cardiac physiologists who manage patients already implanted with or to be implanted with these devices.		  
ACTION:
See Action points on page 3.		  

 >

DISTRIBUTED to:

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

* via CE Bulletin

  

 >
CONTACTS:
Details of manufacturer, 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