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MDA/2005/037 - Guidant VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) model No 1861.

Document details:

Type: Medical Device Alert
Series No: MDA/2005/037
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages:
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/037
Issued: 27 June 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Guidant VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) model No 1861 - see Appendix for full list of affected serial numbers.

 

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 a VENTAK PRIZM® 2 DR ICD.
 
ACTION:
See action points 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