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MDA/2005/064 - ELA Medical implantable pacemaker models

Document details:

Type: Medical Device Alert
Series No: MDA/2005/064
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 9
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/064
Issued: 28 November 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information

DEVICE:
ELA Medical implantable pacemaker models:

Device Family
Model Numbers
 Symphony  DR 2550 and SR 2250
 Rhapsody  DR+ 2530, DR 2510, D 2410 and SR 2210

 See Appendices 1 and 2 for lists of serial numbers of affected devices.

 
PROBLEM:
Potential for loss of pacing output and telemetry without warning.

 >

ACTION BY:
All cardiologists and cardiac physiologists who manage patients with any of these devices.

 

ACTION:
See detailed actions on page 3.

 >

DISTRIBUTED to:

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

* via CE Bulletin

 >

CONTACTS:
Details of manufacturer contacts, 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