BEUDAMED
    FDA Recall Terminated

    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

    Recall: Z-0342-2016 · Initiated November 9, 2015

    Recall

    Recall Number
    Z-0342-2016
    Event Number
    72618
    Firm
    Medtronic Inc.
    FEI Number
    2182208
    Product Code
    NKE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 9, 2015
    Posted
    November 27, 2015
    Terminated
    August 24, 2016
    Address
    8200 Coral Sea St Ne, Saint Paul, MN, 55112-4391

    Description

    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

    Reason

    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.

    Action

    Medtronic sent an Urgent Medical Device Correction letter dated November 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Medtronic records indicate you are following one or more patients with this device. Please see the enclosed Physician/Patient Detail Report. We regret any difficulties this may cause you and your patients. We will continue to monitor device performance and provide regular updates in our product performance report available at wwwp.medtronic.com/productperformance/. Medtronic Patient Services is available to assist patients at 800-551-5544. Medtronic will offer a supplemental device warranty. Contact your sales representative for terms and conditions. If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

    Distribution

    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.

    Quantity

    96,787