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MDA/2004/019 - Medtronic implantable defibrillators, models: Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277.

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Document details:

Type: Medical Device Alert
Series No: MDA/2004/019
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page1

Ref. MDA/2004/019
Issued: 26 April 2004

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Medtronic implantable defibrillators, models: Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277.		  
*
PROBLEM:
Potential battery defect; possible rapid depletion, prevalence unknown.		  
*
ACTION BY:
All cardiologists and cardiac technicians managing patients with the above devices.		  

ACTION:
Clinicians are advised to:

  • Identify and return to Medtronic any of the potentially affected devices not yet implanted (see the lists of affected serial numbers under 'Device' section).
  • Ensure that patients implanted with potentially affected devices are followed up at intervals of no more than three months.
  • Inform all patients to immediately contact their ICD centre if they experience:
    1. Persistent arrhythmias/resumption of symptoms which remain uncorrected by the ICD and/or
    2. Heating sensations or pain in body tissue surrounding the implant.
  
*

DISTRIBUTED to:

NHS Trusts (England) - Chief Executives
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives
 
*
CONTACTS:
Details of manufacturer contacts, MHRA contacts for technical and clinical aspects.		  
*
FEEDBACK REQUIREMENTS:
Report all instances of unexpected battery depletion or telemetry failure to MHRA and Medtronic. Report explants to the National Pacing and ICD database, PO Box 9205, Bridge of Weir, Strathclyde PA11 3DZ, telephone 01505 612 829.		  


* Further information supplied in the following pages.

Page last modified: 07 February 2008