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MDA/2005/041 - Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)

Document details:

Type: Medical Device Alert
Series No: MDA/2005/041
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages:
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/041
Issued: 30 June 2005

IMMEDIATE ACTION  Tick mark
ACTION  
UPDATE  
INFORMATION REQUEST  


  Further Information

DEVICE:
Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)

Device Family
Model Numbers
CONTAK RENEWAL© 4  H190, H195
 CONTAK RENEWAL© 4 HE  H197, H199
 CONTAK RENEWAL© 4 AVT  M170, M175
 CONTAK RENEWAL© 4 AVT HE  M177, M179
 RENEWAL© RF  H230, H235
 RENEWAL© RF HE  H239

 

 
PROBLEM:
Recall due to component failure resulting in potential loss of cardioversion, defibrillation and reduced device longevity.

 >

ACTION BY:
All cardiologists and cardiac technicians who implant and manage patients with any of these devices.
 
ACTION:
See actions on page 2.

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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 the Healthcare Commission.

 >



> Further information supplied in the following pages.

Page last modified: 07 February 2008