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Ref. MDA/2005/048
Issued: 11 August 2005
| IMMEDIATE ACTION |  |
| ACTION | |
| UPDATE | |
| INFORMATION REQUEST |
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This alert supersedes MDA/2005/039. It is important that the guidance issued on 27 June is NOT followed. |
Further Information | ||||||||||
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DEVICE:
See Appendix for list of serial numbers. |
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| PROBLEM: Guidant has revised programming recommendations (previously issued and described in MDA/2005/039) - to reduce risk of a software error that can potentially cause loss of cardioversion, defibrillation, telemetry and programmability. |
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| ACTION BY: All cardiologists and cardiac technicians who implant and manage patients with any of these devices. |
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| ACTION: See actions on page 3. |
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DISTRIBUTED to:
* via CE Bulletin |
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| CONTACTS: Details of manufacture, National Pacing and ICD Database, and 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.
MDA/2005/048 - Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). 
