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Sunday, June 12, 2005Guidant has said that in April 2002 it increased the spacing between a wire and a device component after determining that electricity could potentially arc between them and cause a short circuit. In November 2002, Guidant made another change by adding extra insulation around the component, which is called the backfill tube. The implant data from Abbott Northwestern shows that three patients received implants after November 2002 using devices with earlier apparent manufacturing dates. .....Based on that timeline, the Guidant implant data provided to Dr. Hauser suggests that nine devices with manufacturing dates before April 1, 2002, were implanted in patients at Abbott Northwestern after that time. For example, one device with a manufacturing date of August 8, 2001, was implanted in a patient on May 22, 2002, the data indicates. In addition, seven devices with manufacturing dates in February 2002, two months before Guidant started making fixes, were implanted in patients in July, August and September of that year, the data suggests. [Note: Paragraphs rearranged to make the sequence of events clearer] Uriel Wittenberg also has correspondence with a Guidant advisor that makes for interesting reading. Sounds like someone at Guidant made the wrong decision. posted by Sydney on 6/12/2005 08:53:00 AM 0 comments 0 Comments: |
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