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MDA/2007/078 - Implantable cardioverter defibrillator (ICD) lead. Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/078
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Related information:

MHRA pages:

Page 1

Issued: 19 October 2007 at 11:00
Ref: MDA/2007/078


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Implantable cardioverter defibrillator (ICD) lead. Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949.		  
Problem:
ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.

>Page 2

Action by:
All cardiologists, cardiothoracic surgeons and cardiac physiologists who implant any of these leads or manage patients implanted with them.		  

Action:

  • Do not implant any Sprint Fidelis ICD leads (models listed above).
  • Identify and return to Medtronic any of these leads which have not been implanted.
  • Identify all patients implanted with affected models and arrange a follow-up as soon as practicable (within 8 weeks).
  • Ensure programming parameters are set to maximise the chance of detecting lead fractures and avoiding inappropriate therapy (in accordance with manufacturer’s advice).
  • Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any audible patient alert.
  • Follow up patients at 3-month intervals.

>Pages 2-3

Distributed to:

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

* via CE Bulletin

>Page 3

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

>Pages 3-4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 31 October 2007
Deadline (action complete): 28 December 2007

 

Page last modified: 19 October 2007