FDA-Device2015-12-09Class II
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Medtronic Inc.
Hazard
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
Sold states
Worldwide Distribution - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
Affected count
96,787
Manufactured in
8200 Coral Sea St Ne, Saint Paul, MN, United States
Products
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2016Don't want to check this manually?
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