Affected devices may be contained in the following serial number ranges. Model 1349: Serial numbers 100003 thru 100076. Model 1384: Serial numbers 300000 thru 300073. Model 1385: INITIAL RECALL serial numbers 400005 thru 400019. EXPANDED RECALL serial numbers 400003, 400004. Model 1483: Serial numbers 600005 thru 600082. Model 1484: Serial numbers 700005 thru 700064. Model 1485: INITIAL RECALL serial numbers 800005 thru 800053. EXPANDED RECALL serial numbers 800000, 800001, 800002, 800003, 800004. Model 1499: Serial numbers 200001 thru 200073.
worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.
Description du dispositif
INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. INTELIS II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.