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| Issued: 23 November 2006 at 14:00 |
Ref: MDA/2006/065
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Immediate action |
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Action |
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Update |
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Information request |
| Device: St Jude Medical pacemakers: Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376. St Jude Medical programmers: APS III model 3500, APS III model 3510 and Merlin PCS model 3650. |
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Problem:
at initial programmer interrogation. |
>Page 2 |
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| Action by: All cardiologists, cardiothoracic surgeons and cardiac physiologists who manage patients implanted with these devices. |
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| Action: See detailed actions for patient management on page 3. |
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Distributed to:
* via CE Bulletin |
>Page 3 |
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Contacts: |
>Page 3 |
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| Appendix: Manufacturer's letter. |
>Pages 5-7 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 04 January 2007
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Deadline (action complete): 27 February 2007
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