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MDA/2006/065 - St Jude Medical pacemakers: Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/065
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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MHRA pages:

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Page 1

Issued: 23 November 2006 at 14:00
Ref: MDA/2006/065


 

 
Immediate action
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Device:
St Jude Medical pacemakers:
Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376.
St Jude Medical programmers:
APS III model 3500, APS III model 3510 and Merlin PCS model 3650.

>Page 2

Problem:
Potential for inaccurate display of:

  • battery voltage
  • expected battery longevity
  • Elective Replacement Indicator (ERI) status

at initial programmer interrogation.

>Page 2

Action by:
All cardiologists, cardiothoracic surgeons and cardiac physiologists who manage patients implanted with these devices.		  
Action:
See detailed actions for patient management on page 3.

>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:
Manufacturer's letter.

>Pages 5-7

 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 04 January 2007
Deadline (action complete): 27 February 2007

 

Page last modified: 07 February 2008