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:

Implants, active, leads and electrodes: defibrillator lead - Medtronic Inc - Sprint Fidelis Models 6949, 6931, 6948, 6930

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 19 October 2007 at 11:00

Ref: MDA/2007/078

	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

Download documents:

MDA/2007/078 - Implantable cardioverter defibrillator (ICD) lead. Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949 (771Kb)

Page last modified: 07 February 2008