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MDA/2005/038 - Guidant CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds).

Document details:

Type: Medical Device Alert
Series No: MDA/2005/038
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages:
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/038
Issued: 27 June 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Guidant CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds).
 
PROBLEM:
Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock.

 >

ACTION BY:
All cardiologists and cardiac technicians who manage patients implanted with CONTAK RENEWAL® (model H145) or CONTAK RENEWAL® 2 (model H155) CRT-Ds.
 
ACTION:
See actions on page 3.
 

 >

DISTRIBUTED to:

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

* via CE Bulletin

 

 >

CONTACTS:
Details of manufacturer contacts, National Pacing and ICD Database 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