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MDA/2005/072 - Medtronic Sigma® implantable pacemakers

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/072
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 8
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/072
Issued: 21 December 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information

DEVICE:
Medtronic Sigma® implantable pacemakers:

Model Numbers

SD203
SDR203
SS203
SSR203
SD303
SDR303
SS303
SSR303
SS103
SS106
SDR306
SVDD303

see list of affected serial numbers distributed in the UK under 'Download Documents' below

  

PROBLEM:
Failure of interconnecting wires within the pacemaker may cause:

  • loss of pacing output from atrial and/or ventricular ports
  • premature battery depletion
  • intermittent or total loss of telemetry
  • undersensing
  • high lead impedance values
  • loss of rate response
  • device reset to manufacturer's default settings

 >
ACTION BY:
All cardiologists and cardiac physiologists who manage patients implanted or to be implanted with any of these devices.		  
ACTION:
See detailed actions on page 2 and 3.		  

 >

DISTRIBUTED to:

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

* via CE Bulletin

  

 >

CONTACTS:
Details of manufacturer/National Pacing & ICD Database, 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: 21 December 2005