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MDA/2007/023 - Boston Scientific Ltd: Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/023
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 15 March 2007 at 11:45
Ref: MDA/2007/023

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Boston Scientific Ltd:
Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families (see Appendix 2 for full details of models affected)		  

Problem:

  • Delay in delivery of therapy during device middle-of-life phase due to temporarily extended charge time limits.
  • Transition to device end of life (EOL) without prior observation of elective replacement indication (ERI) even though battery capacity remains available.

>Page 2
Action by:
All cardiologists, cardiothoracic surgeons and cardiac physiologists who implant any of these devices or manage patients implanted with them.		  
Action:
Identify patients implanted with these devices, asses clinical risks associated with the above device problems, and follow the actions on page 2.

>Page 2

Distributed to:

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

* via CE Bulletin

>Page 3
Contacts:
Details of manufacturer and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Page 3

Appendix 1:
Aspects of device behaviour to be considered during patient follow-up, when assessing the appropriateness of patient exposure to extended capacitor charge times.

Appendix 2:
Projected rate of display of replacement indicators during the middle-of-life phase.

>Pages 5-6


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 16 April 2007
Deadline (action complete): 18 June 2007


Page last modified: 07 February 2008