Enter a keyword or phrase to search all pages in this section:


Advanced search

Archive:

Looking for a previously published document in this section?

MDA/2005/047 - Guidant implantable pacemaker models: PULSAR®, PULSAR MAX, PULSAR MAX II, DISCOVERY®, DISCOVERY II, MERIDIAN®, CONTAK® TR, Manufactured between 25 November 1997 and 26 October 2000

Document details:

Type: Medical Device Alert
Series No: MDA/2005/047
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages:
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

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

Ref. MDA/2005/047
Issued: 09 August 2005

IMMEDIATE ACTION   Tick mark
ACTION  
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Guidant implantable pacemaker models:
PULSAR®, PULSAR MAX, PULSAR MAX II, DISCOVERY®, DISCOVERY II, MERIDIAN®, CONTAK® TR,
Manufactured between25 November 1997 and 26 October 2000.

 >

PROBLEM:
Failure of a hermetic seal, potentially leading to one or more of the following problems:

  • loss of pacing output without warning
  • inappropriate rate response function
  • loss of telemetry
  • premature battery depletion
  • earlier than expected display of replacement indicators
  • device reset to manufacturer's default settings.

 >

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

ACTION:
See detailed actions for patient management on page 3 - these include:

  • Review all patients as soon as possible
  • Consider device replacement if pacemaker dependent.

 >

DISTRIBUTED to:

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

* via CE Bulletin

 >

CONTACTS:
Details of manufacturer contacts, National Pacing and ICD Database and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for the Healthcare Commission.

 >



> Further information supplied in the following pages.

Page last modified: 07 February 2008