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| Issued: 13 July 2006 at 15:00 |
Ref: MDA/2006/038
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Guidant implantable pacemaker and implantable defibrillator families: INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR 2, VENTAK PRIZM 2 VITALITY, VITALITY 2 - See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website. |
>Page 2 |
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| Problem: Recall due to component failure. |
>Page 2 |
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| Action by: All cardiologists, cardiothoracic surgeons and cardiac physiologists who manage patients implanted with any of these devices. |
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| Action: See actions on Page 3. |
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Distributed to:
* via CE Bulletin |
>Page 3 |
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| Contacts: Details of manufacturer, National Pacing and ICD Database and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
>Page 4 |
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| Appendix: UK Dear Doctor Letter 28 June 2006. |
>Pages 5 & 6 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 11 August 2006
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Deadline (action complete): 12 September 2006
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Appendix 2 - affected serial numbers - MDA/2006/038 
