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This article was originally published in The Gray Sheet
MEDTRONIC HAS PACEMAKER LEAD SAFETY ALERT ACKNOWLEDGMENTS from all but 95 of the 12,500 physicians contacted by the firm when it issued the alert in October 1993. According to Medtronic, the alert was sent out after company statistical analyses of lead models 4004, 4004M and 4082 indicated that the devices have had more performance problems than expected.
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