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| Issued: 06 February 2006 at 16:00 |
Ref: MDA/2006/006
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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 models: PULSAR®, PULSAR MAX, PULSAR MAX II, DISCOVERY®, DISCOVERY II, MERIDIAN®, CONTAK® TR. |
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Problem:
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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:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer, National and Pacing ICD Database, and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (Action underway): 06 March 2006
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Deadline (Action complete): 06 June 2006
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Download documents:
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MDA/2006/006 - Guidant implantable pacemaker models: PULSAR®, PULSAR MAX, PULSAR MAX II, DISCOVERY®, DISCOVERY II, MERIDIAN® CONTAK® TR (537Kb)
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Serial numbers of 44 potentially affected devices in the UK that should have been included in the list notified in July 2005 (MDA/2005/047) - MDA/2006/006 (10Kb)
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Extension to list of UK and Ireland serial numbers for affected population, notified by Guidant in January 2006 - MDA/2006/006 (63Kb)
